CFDA Announcement No.43 2014
In order to standardize the registration management of medical devices and direct the registration application by the enterprise, the format of the evidentiary documents of requirements and approval for the registration application materials of medical devices is formulated by the China Food and Drug Administration (see Appendix 1-8) according to the Regulations for the Supervision and Administration of Medical Devices (The state council order No. 650) and the Medical Devices Registration Administration Method (China Food and Drug Administration order No. 4), and it is hereby issued and effected on Oct. 1st 2014.
Hereby Announced
Attachment:
1. The Registration Certificate of Medical Devices of the People’s Republic of China (Format)
2. The Registration Changing Document of Medical Devices of the People’s Republic of China (Format)
3. The Approval of Clinical Trial of Medical Devices of the China Food and Drug Administration (Format)
4. The Requirements and Descriptions of the Registration Application Materials of Medical Devices
5. The Requirements and Descriptions of the Renewal Registration Application Materials of Medical Devices
6. The Requirements and Descriptions of the Registration Changing Application Materials of Medical Devices
7. The Requirements and Descriptions of the Application Materials for the Approval of Clinical Trail of Medical Devices
8. List of Basic Requirements of the Safety and Effectiveness of Medical Devices
No. of registration certificate:
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Name of the Registrant |
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Address of the Registrant |
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Production Address |
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Name of the Agent |
(Applicable for imported medical devices) |
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Address of the Agent |
(Applicable for imported medical devices) |
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Product Name |
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Type and Specification |
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Structure and Composition |
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Applicable Scope |
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Appendix |
Product Technical Requirements |
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Other Contents |
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Remark |
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Department for approval: Approved on: Day Month Year
Valid Date: Day Month Year
(Seal by the department for approval)
No. of Registration Certificate:
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Product Name |
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Changing Content |
“*** (Original registration content or item)” is changed to “*** (Content after changing)”. |
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Remark |
The document can be used with “ ” registration certificate. |
Department for approval: Approved on: Day Month Year
(Seal of the department for approval)
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Applicant |
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Address of the Applicant |
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Name of the Medical Devices for Trial |
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Type and Specification of Medical Devices of Trial |
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Structure and Composition of Medical Device for Trial |
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Approval Advice |
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To |
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cc |
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Remark |
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Department for Approval: Approved on:Day Month Year |
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(Seal by the department for approval) |
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First Heading of Declaration Data |
Secondary Heading of Declaration Data |
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1. Application form |
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2. Probative document |
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3. List of safe and effective basic requirements of medical instruments |
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4. Summary |
4.1 Overview 4.2 Product description 4.3 Model specifications 4.4 Packing instruction 4.5 Range of application and contraindication 4.6 Condition of referential like product or product of previous generation (if any) 4.7 Other contents required to be explained |
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5. Research data |
5.1 Product performance research 5.2 Biocompatibility evaluation research 5.3 Biological safety research 5.4 Sterilization and disinfection technical study 5.5 Period of validity and packaging research 5.6 Animal research 5.7 Software research 5.8 Others |
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6. Manufacturing information |
6.1 Productive process information description of passive product/active product 6.2 Production field |
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7. Clinical assessment data |
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8. Product risk analysis data |
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9. Product technical requirements |
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10. Product registration inspection report |
10.1 Registration inspection report 10.2 Pre-assessment opinion |
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11. Sample of specification and label |
11.1 Specification 11.2 Label sample of minimum marketing unit |
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12. Declaration of conformity |
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All in formation of the registration shall have a catalogue, including the first and the second class subjects of the information. The corresponding data of the second data shall number the page alone.
1 Application Form
2 Probative Document
2.1 Domestic applicant should submit:
2.1.1 Copy of business license duplicate and copy of Organization Code Certificate.
2.1.2 When the application for registration is made according to domestic medical instruments of Approval of Special Vetting Process of Innovative Medical Instruments, the letter of examination notice of special vetting process of innovative medical instruments should be submitted and in case other enterprises are entrusted to produce samples, the production license of the entrusted enterprises and the consignment agreement should be provided. The production range of the production license should contain declared product category.
2.2 Overseas applicant should submit:
2.2.1 Supporting documents allowing the sale of products and documentary evidence for enterprise qualification provided by medical instrument competent department of the country (district) in which the registration place or the address for manufacturing of an overseas applicant is.
2.2.2 If the product is not managed as the medical instrument in the country (district) in which the registration place or the address for manufacturing of an overseas applicant is, the applicant should provide relevant documentary evidence including the supporting document for the sale of the product of the country (district) in which the registration place or the address for manufacturing of an overseas applicant is.
2.2.3 The letter of authorization for overseas applicant to appoint agent within the territory of China, the letter of commitment of the agent and the copy of business license duplicate or the copy of organization registration certificate.
3 List of Safe and Effective Basic Requirements of Medical Instruments
Methods adopted for explaining that the product conforms to various applicable requirements of List of Safe and Effective Basic Requirements of Medical Instruments (please see attachment 8) and documents proving its conformity. Reasons for various inapplicable requirements in List of Safe and Effective Basic Requirements of Medical Instruments should be explained.
For the document contained in the product registration declaration data, its specific location in the declaration data should be given; for the document not contained in the product registration declaration data, its name and serial number in the quality management system document should be indicated for future reference.
4 Summary
4.1 Overview
Describing management class, sorting code number and name determination basis of declared product.
4.2 Product description
4.2.1 Passive medical instrument
Describing contents including the operating principle, mechanism of action (if applicable), structural composition (including accessories used cooperatively) and main raw materials of the product and characteristics differing from that of other like products; providing graphical explanation when necessary.
4.2.2 Active medical instrument
Describing contents including the operating principle, mechanism of action (if applicable), structural composition (including accessories used cooperatively) and main functions of the product, functions of its component parts (key components and software) and characteristics differing from that of other like products; providing graphical explanation when necessary.
4.3 Model specifications
For the product with various model specifications, it is necessary to make clear the differences of various model specifications. Correlation table and pictures and charts with descriptive texts should be adopted to describe structural composition (or configuration), function, product features and running mode, performance index etc of various models specifications.
4.4 Packing instruction
Information relevant to product packaging and packaging condition of accessories sold together with the product; for sterile medical instrument, the information about the primary packaging adaptive to the sterilization method should be introduced.
4.5 Range of application and contraindication
4.5.1 Range of application: it is necessary to make clear that the therapy, diagnosis etc provided by the product conform to the purpose of the definition of Article Seventy-six of Medical Instrument Supervision and Administration Regulations and it is able to describe its applicable medical phase (such as supervision, recovery etc after treatment); to make clear target users and their skills/knowledge/training that should be owned to operate the product; to explain whether the product is disposable or reusable; to describe the instrument expected to be used cooperatively with the product.
4.5.2 Expected operating environment: expected operating locations of the product include medical institution, laboratory, ambulance, family and environmental conditions that may affect the safety and effectiveness of the product (such as temperature, humidity, power, pressure, movement etc).
4.5.3 Target user: information about target patients (such as adults, children or newborn), information about patient selection criteria and parameters to be monitored and factors to be considered during the use procedure.
4.5.4 Contraindication: if applicable, it is necessary to specify diseases, conditions or specific groups (such as children, old people, pregnant and breast feeding women, people with hepatic and renal dysfunction) for which the instrument is not suitable.
4.6 Information about referential like product (already launched at home and abroad) or product of previous generation (if any) should be provided and the research and development background and purpose of the product applied for registration should be elaborated. For like product, the reason why it is selected as the reference for the research and development should be explained.
At the same time, tables should be listed to comparatively explain similarities and differences between the product and the referential product (like product or product of previous generation) in aspects of operating principle, structural composition, manufacturing material, performance index, mode of action (such as implantation, intervention) and range of application.
4.7 Other contents to be illustrated. For parts having been approved or accessories used cooperatively, approval number and the copy of document of approval should be provided; introductions should be provided for the product which is expected to be used cooperatively with other medical instruments or general products; physical and electrical connection types of all cooperative medical instruments of the system should be illustrated.
5 Research Data
Applicable research data are provided according to the declared product.
5.1 Product performance research
Product performance research data and research and preparation instructions of product technical requirements should be provided, including the determination basis for function and security indexes (electric safety and electromagnetic compatibility, radiation safety) and other indexes relevant to quality control, adopted standard or method, adopted reason and theoretical basis.
5.2 Biocompatibility evaluation research
The biocompatibility of the material in a finished product that is in direct or indirect contact with patient and user should be evaluated.
The biocompatibility evaluation research data should include:
5.2.1 Basis and method for the biocompatibility evaluation.
5.2.2 Description of the material used in the product and the property of its contact with human body.
5.2.3 Reason and argument for the implementation or exemption of biology test.
5.2.4 Evaluation on available data or test results.
5.3 Biological safety research
For those products containing allogeneic material, animal derived material or bioactive substance which has bio-safety risk, relevant materials and biological safety research data of the bioactive substance should be provided, including the explanation of the acquisition, processing, conservation, test and processing procedure of tissue, cell and material; the elaboration of source (including donor selecting details) and the description of verification test for the removing or inactivation method of virus, other pathogens and immunogenicity substances during the productive process; brief summary of process certification.
5.4 Sterilization/disinfection technical study
5.4.1 Sterilization for manufacturing enterprise: sterilization process (method and parameter) and Sterility Assurance Level (SAL) should be made clear and sterilization confirmation report should be provided.
5.4.2 Sterilization for end-user: recommended sterilization process (method and parameter) and the determination basis for the recommended sterilization method should be made clear; for the product that can tolerate sterilization two or more times, the relevant tolerance research data of the recommended sterilization method of the product should be provided.
5.4.3 Residual toxicity: if the sterilization method used may easily cause residue, the information about the residue and the adopted processing method should be made clear and the research data should be provided.
5.4.4 Disinfection for end-user: the recommended disinfection technology (method and parameter) and the determination basis for the recommended disinfection method should be made clear.
5.5 Period of validity and packaging research of product
5.5.1 Determination of period of validity: if applicable, the verification report of the period of validity of the product should be provided.
5.5.2 For medical instrument reused for limited times, the verification data for the number of use should be provided.
5.5.3 Packaging and packaging integrity: ensure the packaging is integrity under the transport and store condition, within the period of validity.
5.6 Preclinical animal experiment
If applicable, the purpose, results and records of the animal experiment research should be included.
5.7 Software research
For the product with software, a separate medical instrument software description document should be provided, the content of which includes basic information, realization process and core algorithm and the level of detail of which depends on the safety level and complexity of the software. At the same time, a statement of the naming rule for the software version should be provided, all fields and the meaning of the fields of the software version should be made clear and the full version of the software and the marking version used for publishing should be determined.
5.8 Other information
Other research data which can prove the product is safe and effective.
6 Manufacturing Information
6.1 Passive medical instrument
It is necessary to make clear the production and the processing technologies of the product, give clear indication of key technology and special technology and explain the process control point. The service condition of various processing agents and the control of impurities (such as residual monomer, micromolecule residue etc) during the productive process should be made clear.
6.2 Active medical instrument
The technical process of production of the product should be made clear, the form of flow chart can be adopted and the process control point should be illustrated.
Notes: the description about the productive process information in (Ⅰ) of “Ⅵ Manufacturing Information” should be considered to be adopted for a part of active medical instruments (for example: cardiac pacemaker and conductor).
6.3 Production field
There are many development and production fields and the actual condition of every development and production field should be summarized.
7 Clinical Assessment Data
The clinical assessment data should be submitted according to relevant regulations. For imported medical instrument, the clinical assessment data of the medical instrument competent department of the overseas government approving the product launch should be provided.
8 Product Risk Analysis Data
The product risk analysis data mean the data formed by the recording of the risk management process of the product and its evaluation result. The traceability of every following process, the harm of which has already been determined, should be provided:
8.1 Risk analysis: Including the determination of the range of application of medical instrument and the features related to safety, the determination of harm and the estimation of the risk of every hazardous situation.
8.2 Risk evaluation: For every determined hazardous situation, evaluating and deciding whether to lower the risks.
8.3 Implementation and verification results of risk control measures. When necessary, test and evaluation reports should be quoted, such as medical electric safety, biological assessment etc.
8.4 Acceptability assessment of any or more risks.
9 Product Technical Requirements
The medical instrument product technical requirements should be compiled according to the stipulation of the “Compiling Guideline of Medical Instrument Product Technical Requirements”. The product technical requirements should be made in duplicate and two statements with completely consistent product technical requirements.
10 Product Registration Inspection Report
Registration inspection report and pre-assessment opinions given by medical instrument inspection body with medical instrument inspection qualification should be provided.
11 Sample of Product Specification and Minimum Marketing Unit Label
Requirements of relevant laws and regulations should be conformed to.
12 Declaration of Conformity
12.1 The applicant declares that the product conforms to Medical Instrument Registration Administrative Measures and the requirements of relevant laws and regulations, declares that the product conforms to the requirement of classification in Medical Instrument Classification Rules, declares that the product accords with the current national standard and industry standard and provides the list conforming to the standards.
12.2 Self-guarantee statement for the truth of submitted data (given by the applicant for domestic products and given respectively by the applicant and the agent for imported products).
1 Application Form
2 Evidentiary Documents
For domestic registrant, a photocopy of the duplicate of enterprise business license and a photocopy of organization code certificate shall be provided; for overseas registrant, a letter of authorization for the agent authorized in China, a letter of commitment of the agent, a photocopy of the duplicate of enterprise business license and a photocopy of organization registration certification shall be provided.
Note: for the renewal registration of imported medical device, it is not necessary to provide the evidentiary documents for the product to be marketed approved in the registration place of the registrant or the country (region) of the production address.
3 Statement of No Changes to the Product
The registrant shall provide the statement of no changes to the product.
4 A photocopy of the original registration certificate of medical devices and its Appendixes, a photocopy of the document for each previous change to medical device registration.
5 Product Analysis Report within the Valid Period of Registration Certificate
5.1 Product clinical application status, user complaint status and measures taken.
5.2 For the evaluation summary report of adverse events by medical devices, a list shall be made for the suspicious adverse events after the product is marketed to describe the handling measures and resolution taken by the manufacturer under each circumstance. It aims to analyze and evaluate the above adverse events, explain the reasons for the occurrence of adverse events and describe their effects on the product safety and effectiveness.
5.3 Descriptions of product marketing status in all countries and regions.
5.4 Product supervision and selective acceptance status (if any).
5.5 If a recall is made after product marketing, the reason, process and handling results of the recalled products shall be described.
5.6 For the medical device registration certificate that requires continuing the work, related summary report shall be provided, and related data shall be attached.
6 Product Inspection Report
If the medical device mandatory standard has been revised, a product inspection report to prove that the product meets the new requirements shall be provided. The product inspection report can be the self-inspection report, authorized inspection report or the inspection report conforming to the requirements in the notice of mandatory standard implementation. Among them, the authorized inspection report shall be issued by the medical device inspection unit with related medical device inspection qualifications.
7 Conformity Statement
7.1 The registrant states that this product conforms to the regulations in the Medical Device Registration Management Measures and related regulations; the registrant states that this product conforms to existing national standard and industry standard, and a list of conformity standard shall be provided.
7.2 The self-assurance statement of the authenticity of the submitted materials (that for domestic product is issued by the registrant, and that for imported product shall be issued by the registrant and the agent respectively).
8 Others
If there are changes to the product technical requirements within the valid period of the original registration certificate of medical devices, the registration changing document of product technical requirements shall be submitted in duplicates.
1 Application Table
2 Evidentiary Documents
2.1 Domestic applicants shall submit:
2.1.1 A photocopy of the duplicate of enterprise business license.
2.1.2 A photocopy of organization code certificate.
2.2 Overseas applicants shall submit:
2.2.1 If the changing item is in the registration place of overseas registrant or the country (region) of production address, a new evidentiary document for the product to be marketed issued by the competent department of medical devices and enterprise qualification certificate are needed, and related documents shall be provided. If the changing item need no approval from the competent department of medical devices in the registration place of the registrant or the country (region) of production address, related descriptions shall be provided.
2.2.2 A letter of authorization and a letter of commitment of the agent authorized within the territory of China by the overseas applicator as well as a photocopy of the duplicate of business license or a photocopy of the organization registration certificate.
3 Statement of Related Changes by the Registrant
4 The photocopies of original registration certificate of medical devices and its Appendixes, photocopies of all registration changing documents of medicinal devices.
5 Requirements of Application Materials for Changing Application Items
5.1 Changes to registrant name
The approval notice of change to company name (Registrant in China), and/or the change information explanations in detail, and the corresponding documentary.
5.2 Changes to registrant address
Change information explanations in detail, and the corresponding documentary.
5.3 Change to address of manufacturing site in China
Provide the corresponding the manufacturing certificate of the alteration.
5.4 Change to agent
5.4.1 The registrant shall submit a statement for the changes to the agent.
5.4.2 The registrant shall submit a letter of authorization for the new agent, and a letter of commitment submitted by the new agent.
5.4.3 A photocopy of the duplicate of business license and a photocopy of organization registration certificate of the agent after changing.
5.5 Changes to the agent’s address:
A photocopy of the duplicate of business license and a photocopy of organization registration certificate after changing.
6 Conformity Statement
6.1 The registrant states that this product conforms to the regulations of the Medical Device Registration Management Measures and related regulations; the registrant states that the product conforms to existing national standard and industry standard, and the list of conformity standard shall be provided.
6.2 The self-assurance statement of the authenticity of submitted materials (that of the domestic product is submitted by the registrant, and that of imported product is submitted by the registrant and the agent respectively).
1 Application Table
2 Evidentiary Documents
2.1 Domestic applicants shall submit:
2.1.1 A photocopy of the duplicate of enterprise business license.
2.1.2 A photocopy of organization code certificate.
2.2 Overseas applicants shall submit:
2.2.1 If the changing item is in the registration place of overseas registrant or the country (region) of production address, a new evidentiary document for the product to be marketed issued by the competent department of medical devices and enterprise qualification certificate are needed, and related documents shall be provided. If the changing item need no approval from the competent department of medical devices in the registration place of the registrant or the country (region) of production address, related descriptions shall be provided.
2.2.2 A letter of authorization and a letter of commitment of the agent authorized within the territory of China by the overseas applicator as well as a photocopy of the duplicate of business license or a photocopy of the organization registration certificate.
3 Statement of Related Changes by the Registrant
4 The photocopies of original registration certificate of medical devices and its Appendixes, photocopies of all registration changing documents of medicinal devices.
5 Requirements of Application Materials for Changing Application Items
The following documents shall be submitted according to specific changing status:
5.1 Changes to product name, comparison table and related descriptions.
5.2 Changes to product technical requirements, comparison table and related descriptions.
5.3 Changes to product types and specifications, comparison table and related descriptions.
5.4 Changes to structure and composition, comparison table and related descriptions.
5.5 Changes to product applicable scope, comparison table and related descriptions.
5.6 Changes to production address of imported medical devices, comparison table and related descriptions.
5.7 Changes to "other contents” in the registration certificate, comparison table and related descriptions.
5.8 Description of other changes.
6 Safety Risk Management Report Related to Product Changes
7 Materials on the Effects of Changed Part on Product Safety and Effectiveness
The effect of changed part on product safety and effectiveness shall be analyzed and described, and related study data shall be provided. Clinical evaluation data must be provided for changes to applicable scope.
8 Registration Inspection Report on the Changing Part of Product Technical Requirements
9 Conformity Statement
9.1 The registrant states that this product conforms to the regulations of the Medical Device Registration Management Measures and related regulations; the registrant states that the product conforms to existing national standard and industry standard, and the list of conformity standard shall be provided.
9.2 The self-assurance statement of the authenticity of submitted materials (that of domestic product shall be provided by the registrant, and that of imported product shall be provided by the registrant and the agent respectively).
1 Application Table
2 Evidentiary Documents
2.1 Domestic applicants shall submit:
2.1.1 A photocopy of the duplicate of enterprise business license.
2.1.2 A photocopy of organization code certificate.
2.2 Overseas applicants shall submit:
2.2.1 The evidentiary document for the product to be marketed issued by the competent department of medical devices in the registration place of the applicant and the country (region) of production address and legal qualification evidentiary document.
2.2.2 A letter of authorization and a letter of commitment of the agent authorized within the territory of China by the overseas applicator as well as a photocopy of the duplicate of business license or a photocopy of the organization registration certificate.
3 Test Product Description
The description shall include the design principles, operation principles, product characteristics, structural composition and diagram, manufacturing materials, packaging materials, types and specifications and classification basis, main production technology, delivery status, action mechanism and applicable scope of medical device for test.
4 Pre-clinical Study Data
Generally, the data shall include:
4.1 The pre-clinical study data of the medical devices for test by the applicator. For example, laboratory study and animal test, etc.
4.2 The already published literature and critical reviews on the safety and effectiveness of medical devices for evaluation test.
4.3 The R&D, marketing and clinical application of domestic and overseas products of the same class and comparison data on the similarities and differences of the operation principles, structural composition, manufacturing materials, technical parameters and applicable scope, etc., between the medical devices for test domestic and overseas products of the same class.
4.4 Information of adverse events related to medical devices for test.
4.5 Comparison analysis report of benefit and risk of clinical test.
4.6 Study data submitted for other requirements.
5 Product Technical Requirements
6 The registration inspection report and pre-evaluation advice submitted by medical device inspection organizations
7 Instructions for use and label template
8 Clinical test protocol
The clinical test protocol shall conforms to related requirements of the Medical Device Clinical Trial Quality Management Standard issued by the China Food and Drug Administration, and the analysis materials to prove the scientific rationality of clinical trial protocol shall be provided.
9 Written Advice to Conduct Clinical Trial Approved by the Ethics Committee
The written advice to conduct clinical trial approved by all Ethics Committees of the clinical trial organizations shall be submitted.
10 Conformity Statement
10.1 The applicator states that the product conforms to the requirements of the Medical Device Registration Management Measures and related regulations.
10.2 The applicator states the authenticity of submitted materials.
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Term No. |
Requirements
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Applicability
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The methods used to prove the conformity |
The documents to provide objective evidence for the conformity |
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A |
General principles |
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A1 |
The design and production of medical devices shall ensure under intended conditions and applications, the intended users (if applicable) with corresponding technical knowledge, experience, education background, training experience, medical hardware conditions can use the product as per intended usage, not damaging medical environment, patient safety, or the user’s and other’s safety and health; compared with the benefit to the patient, the potential risk during the use is acceptable, and there are high-level health and safety protection methods.
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A2 |
The design and production of medical devices shall follow safety principles and also give considerations to existing technical capabilities, and following principles shall be used to ensure the residue risk of each hazard is acceptable: a. The known and expected hazards shall be identified, and the risks of expected use an expected improper use shall be evaluated. b. The risks shall be eliminated as far as possible during the design and production. c. The residue risks shall be reduced as far as possible with sufficient protective measures (e.g., send out alarm, etc.). d. The residual risks shall be informed. |
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A3 |
The use of medical devices under prescribed using conditions shall meet expected properties to satisfy the requirements of applicable scope. |
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A4 |
During the life cycle, under normal using and maintenance conditions, the degeneration degree of the characteristics and properties of medical devices will not affect their safety. |
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A5 |
The design, production and package of medical devices shall be able to ensure the transport, storage conditions (e.g., temperature and humidity changes) prescribed in the instructions for use exert no adverse effects to the characteristics and properties of the products. |
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A6 |
All risks and unintended effects shall be minimal and acceptable to ensure the benefit of normal use is greater than the risk. |
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B |
Basic principles of the safety properties of medical devices |
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B1 |
Chemical, physical and biological properties |
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B1.1 |
The materials shall be able to ensure the medical devices conform to the requirements specified in section A, and special attention shall be given: a. Special considerations shall be given to the toxicity and inflammability during the selection of the materials (if applicable). b. The compatibility between the materials and the biological tissues, cells and body fluid shall be considered according to their applicable scope. c. The hardness, abrasive resistance, fatigue strength and other properties (if applicable) shall be considered during the selection of the materials. |
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B1.2 |
The risks of contaminants and residues to the persons involved in the transport, storage and usage and the patients shall be reduced as far as possible during the design, production and package of medical devices, and special attention shall be given to the contacting time and frequency of human body exposed tissue.
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B1.3 |
The design and production of medical devices shall be able to ensure the safe use of the product when the product contacts other materials, substances and gases during normal use. If a medical device is used for drug administration, the design and production of this product shall conform to related regulations of drug management and its normal use shall not change product performance. |
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B1.4 |
Special considerations shall be given to the risks caused by filtrate and leakage for the design and production of medical devices, especially the carcinogenesis, teratogenesis and reproductive toxicity. |
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B1.5 |
The product and its using environment characteristics under intended using conditions shall be considered for the design and production of medical devices to reduce the risk caused by the access of foreign matter to the product by accident. |
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B2 |
Infection and microbial contamination |
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B2.1 |
The risks to the patient and the user and infection to others shall be reduced for the design and production of medical devices. The design shall: a. Be easy to operate. b. Reduce the microbial leakage and/or microbial exposure from the product during the using. c. Prevent the microbial contamination to medical devices and samples by human. |
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B2.2 |
The microbial requirements shall be met for the medical devices marked with microbial requirements before using. |
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B2.3 |
The sterile medical devices shall be ensured conforming to sterile requirements before using. |
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B2.4 |
The verified methods shall be used for the processing, manufacturing and sterilization of sterile medical devices or medical devices marked with microbial requirements. |
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B2.5 |
The sterile medical devices shall be produced under corresponding control conditions (environment of corresponding clean grade). |
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B2.6 |
The package of non-sterile medical devices shall be kept clean and complete. For the products that need sterilization before using, the packages shall reduce the risks of microbial contamination to the products as far as possible, which shall meet appropriate corresponding sterilization method. |
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B2.7 |
The medical devices can be marketed in sterile and non-sterile forms, and the packages and labels of the products shall be distinguished. |
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B3 |
Combined products of drug instruments |
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B3.1 |
The product safety, quality and performance of drug and drug instrument combination shall be verified. |
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B4 |
Biologically derived medical devices |
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B4.1 |
For the medical devices containing animal derived tissues, cells and other substances, the animal derived tissues, cells and other substances shall conform to related regulations, and meet their applicable scope requirements. The animal derivation materials shall be properly stored for future record. For the processing, storage, inspection and treatment process of animal tissues, cells and other substances, the optimal safety protection for the patients, users and others shall be provided (if applicable). For special virus and other pollution source, the verified treatment methods for clearing and sterilization shall be used. |
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B4.2 |
For the medical devices containing human tissues, cells and other substances, proper source and donor shall be selected to reduce the risk of infection. For the processing, storage, inspection and treatment process of human tissues, cells and other substances, the optimal safety protection for the patients, users and others shall be provided (if applicable). Especially for the virus and other pollution source, the verified treatment methods for clearing and sterilization shall be used. |
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B4.3 |
For the processing, storage, inspection and treatment process of the medical devices containing microbial cells and other substance, the optimal safety protection for the patients, users and others shall be provided (if applicable). Especially for the virus and other pollution source, the verified treatment methods for clearing and sterilization shall be used.。 |
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B5 |
Environmental characteristics |
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B5.1 |
For intended combined use of medical devices with other medical derives or instruments, the safety of the entire system shall be ensured after combined use, and the performance of various instruments and equipment shall not be weakened. The limits of any combined use shall be marked on the labels and/or instruction for use. For the connection system for the liquid and gas transmission and mechanical coupling, the safety risk of the fault connection to the user shall be reduced to minimum from the design and structure aspects. |
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B5.2 B5.2.1 |
The following risks shall be eliminated and reduced to minimum for the design and production of medical devices. The risks of hazards to the patients, users and other persons due to physical or human-machine ergonomics factors. |
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B5.2.2 |
The risks of faulty operation caused by human-machine ergonomics, human factors and using environment.
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B5.2.3 |
The risks related to rationally expectable external factor or environmental conditions, for example, the changes in radiation, pressure, temperature, humidity, force and accelerated speed caused by magnetic field, external electromagnetic effects, electrostatic discharge, diagnosis and treatment, etc.
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B5.2.4 |
The risks contacting the materials, liquid and gas during normal using. |
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B5.2.5 |
The risks caused by the compatibility of software and its operation environment. |
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B5.2.6 |
The risks of the access of foreign matter by accident. |
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B5.2.7 |
The risks of the interference by other medical devices in the combined use of this product in clinical practice. |
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B5.2.8 |
The risks caused by material aging, reduction of measurement or control accuracy due to inability to maintain or calibrate (implanted product) the medical devices. |
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B5.3 |
For the design and production of medical devices, the risks of combustion and explosion shall be reduced to minimum during normal using and under single faulty conditions. Especially the medical devices exposure to combustibles and inflammables and the combined use of medical devices with combustibles and inflammables during expected using. |
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B5.4 |
For the design and production of medical devices that must be adjusted, calibrated and maintained, they shall be ensured to be operated safely during corresponding process. |
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B5.5 |
For the design and production of medical devices, safety disposal of the waste shall be ensured. |
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B6 |
The products of medical devices with diagnostic and measurement functions |
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B6.1 |
For the medical devices with diagnostic or measurement functions, full considerations shall be given to the precision, accuracy and stability for the design and production. Limiting value shall be prescribed for the accuracy. |
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B6.2 |
The design of any measurements or monitored or indicated value range shall meet the principals of human-machine ergonomics. |
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B6.3 |
The standardized units commonly used in China shall be used for the expressed variables, which shall be understandable to the users. |
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B7 |
Radiation protection |
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B7.1 |
General requirements: for the design, production and package of medical devices, full considerations shall be given to the reduction of radiation exposure to the patients, users and others (not affecting to the factions). |
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B7.2 |
Intended radiation: for the medical devices using radio-radiation for the treatment and diagnosis, the dose of radio-radiation shall be controllable. The design and production shall ensure the repeatability of adjustable parameters and the error in allowed range. There shall be light and sound alarming functions to possible hazard of the expected radiation of medical devices. |
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B7.3 |
Unintended radiation: for the medical devices, the risks of the exposure of the patients, users and other to unintended, stray or scattered radiations shall be reduced to minimum. |
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B7.4 |
Ionizing radiation: for the design and production of the medical devices sending out intended ionization radiation, the dose of radiation, geometric distribution and energy distribution (mass) shall be controllable. For the design and production of the medical devices sending out ionization radiation (intended for radiology diagnosis), the dose of radiation to the patients and users shall be reduced to minimum (at the same time ensuring the imaging quality required clinically). Reliable monitoring and control shall be performed for the dose, type, energy and energy distribution of ray bundles (if applicable). |
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B8 |
Medical devices with software and independent software for medical devices |
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B8.1 |
For the design of medical devices with software and independent software for medical devices, the repeatability, reliability and performance shall be ensured. When a single fault occurs, proper measures shall be taken to eliminate and reduce the risks as far as possible. |
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B8.2 |
For the medical devices with software and independent software for medical devices, the software must be verified with latest technological levels (full considerations shall be given to R&D cycle, risk management requirements, verification and conformation requirements). |
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B9 |
Active medical devices and related connective instruments |
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B9.1 |
When single fault occurs in active medical devices, proper measures shall be taken to eliminate and reduce the resultant risks to minimum. |
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B9.2 |
The safety of the patient shall be guaranteed by the medical devices supplied by internal electric source, the medical devices shall feature the power supply examinations. |
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B9.3 |
The safety of the patient shall be guaranteed by the medical devices supplied by internal electric source, the medical devices shall include the alarming system indicating power failure. |
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B9.4 |
For the medical devices intended for monitoring one or several clinical parameters, proper alarming system shall be equipped to give out alarms in case the patient’s life and health are severely deteriorating or the life is in stake. |
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B9.5 |
For the design and production of medical devices, there shall be the method to reduce electromagnetic interference. |
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B9.6 |
For the design and production of medical devices, the products shall be ensured to have sufficient capability of anti-electromagnetic disturbance to ensure the product operates as expected. |
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B9.7 |
For the design and production of medical devices, after the products are installed and maintained as per the requirements, the patients, users and other shall be protected from electric shock by accident under normal using and single fault. |
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B10 |
Prevention of mechanical risks |
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B10.1 |
For the design and production of medical devices, the patients and users shall be protected from the mechanical risks caused by resistance in moving, unstable components and moving parts, etc. |
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B10.2 |
Except the vibration is the special property requirements of medical devices, for the design and production of medical devices, the risks of product vibration shall be reduced to minimum. If practical, the method of restrictive vibration shall be used (especially for vibration source). |
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B10.3 |
Except the vibration is the special property requirements of medical devices, for the design and production of medical devices, the risks caused by product noise shall be reduced to minimum. If practical, the method of restrictive noise shall be used (especially for noise source). |
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B10.4 |
The terminals and connectors for connecting electricity, gas or providing hydraulic pressure and air pressure that shall be operated by the user, the design and structure shall reduce the risk from operation to minimum. |
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B10.5 |
If some parts of medical devices shall be connected or re-connected before and during the using, the risks caused by connection error shall be reduced to minimum for product design and production. |
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B10.6 |
For the accessible components of medical devices (not including the components and areas intended to provide heat or reach special temperature) and surroundings, normal operation shall not cause the temperature leading to hazards. |
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B11 |
Preventing the risks caused by the energy and substances provided to the patient |
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B11.1 |
For the medical devices to provide energy and substances to the patient, the design and structure shall accurately set and maintain the output quantity to ensure the safety of the patients and users. |
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B11.2 |
If the output quantity is not sufficient to cause hazard, the medical devices shall prevent and/or indicate the functions of “insufficient output quantity”. There shall be proper preventative methods to prevent the output of energy and substances reach hazard grade by accidents. |
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B11.3 |
The functions of the controller and indicator shall be clearly marked on the medical devices. If the display system indicates the direction for use, operation status or adjustment parameters during the operation of the devices, such information shall be easy to understand. |
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B12 |
Preventing the risks from the use by non-professional users |
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B12.1 |
For the design and production of medical devices, consideration shall be given to the knowledge, techniques and using environment mastered by non-professional users, and sufficient descriptions shall be provided for easy understanding and using. |
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B12.2 |
For the design and production of medical devices, the risks of operation error or understanding error by non-professional users shall be reduced to minimum. |
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B12.3 |
The procedure for non-professional users to inspect the product for normal operation during the using process shall be set as far as possible. |
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B13 |
Labels and instructions for use |
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B13.1 |
Considering the trainings taken and knowledge owned by the users, the labels and instructions for use shall provide sufficient information to the users to identify the manufacturer and safely use the product to achieve expected functions. The information shall be easy to understand. |
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B14 |
Clinical evaluation |
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B14.1 |
The clinical evaluation materials of medical devices shall be provided as per existing regulations. |
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B14.2 |
The clinical trial shall conform to the Declaration of Helsinki. The approval of clinical trial shall according to the regulations of existing laws. |
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Description |
1. If Line 3 is applicable, mark “Yes”. If inapplicable, mark “No", and give the reasons for inapplicable. 2. The method to prove the medical devices conform to the basic requirements of safety and effectiveness shall be filled in Line 4, generally the following methods can be used to prove the conformity to basic requirements: a. Conform to the issued regulations and normative documents of the medical device department. b. Conform to medical device related national standard, industry standard and international standard. c. Conform to generally accepted test method. d. The method defined by the enterprise. e. Comparison with the products of the same class that have been approved for marketing. f. Clinical evaluation. 3. The evidence provided for conformity shall be marked with the position and number in the registration application materials. For the documents contained in the product registration application materials, their specific position in application materials shall be described. For example: 8. Registration inspection report (Medical electric safety: The section of prevention of mechanical risks); Chapter 4.2 of the instructions for use. For the documents not included in product registration application materials, the names of these evidentiary documents and their numbers in the documents of quality management system shall be marked for future check. |
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