The MDCSS contains over 4000 types of medical devices which approved in Chinese market. There are included class I, class II, class III medical devices as well as product which not considered as medical devices (Non medical devices).

Class I Medical Devices are those with low risk degree and for which safety and effectiveness can be ensured through routine administration

Class II Medical Devices are those with moderate risk and for which strict administration is required to ensure their safety and effectiveness

Class III Medical Devices are those with higher risk and for which must be strictly controlled via special measures in respect to safety and effectiveness

Non Medical Devices are those not managed as medical device under CFDA related regulations, or it doesn’t meet the definition of medical devices.

Medical Devices are defined as any instrument, apparatus, appliance, material, in vitro diagnostic reagents and calibration substances and other similar substances and related articles, including the needed computer software. Its main effectiveness is achieved via physics ways and so on. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:

1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
3. Investigation, replacement or modification for anatomy or a physiological process;
4. Life support or maintenance;
5. Control of conception；
6. Offer information for medical or diagnosis purpose via inspecting the human samples.

What does it do?

MDCSS lists the product name, classification name, classification codes, intended purpose, structure features, and the managing category. The medical device name and classification codes identify the generic category of medical device for CFDA and the classification assigned to a medical device is based upon the classification rule of medical device designated under the Regulations for the Supervision and Administration of Medical Device (State Council Decree No. 650).

MDCSS enables you to determine the managing category/class of medical device with regulatory controls by classification code, classification name or product name. MDCSS also provides initial assessment of your regulatory obligations under CFDA regulations. CIRS is constantly maintaining its database to keep it up to date.

How it works?

• Input product identifier and verification code;
• View classification and relevant information of your product;

The MDCS is defined according to the latest medical devices classification rules (The Provisions for Medical Device Classification) issued by CFDA. Medical Devices (including IVD) are divided into three managing categories: class I, class II and class III medical devices based on the different risk level. There are higher controlled requirements if the product classified as higher level, such as class II or class III, and there are different requirements for each level as well. So the confirmation of the classification is the most important process and the first step to start the medical device registration.

What does it do?

The classification should be determined by the combined judgment from four aspects: intended purpose, structural features, intended for use and use descriptions. MDCS enables you to determine the managing category for your product by screening the factors of intended purpose, structural features, intended for use and use descriptions. MDCS also provides initial assessment of your regulatory obligations under CFDA regulations. CIRS is constantly maintaining its rules to keep it up to date.

How it works?

• Select the intended purpose of your product, and
• Select the structural feature of your product, and
• Select the intended for use of your product, and
• Select the use descriptions of your product, then
• View classification (managing category ) of your product
• Input your email address and send the classification result with initial registration proposals to your email;

The MDRGD contains the relevant medical device regulations, guidance and related technical measures, and those are for search queries only. Those are divided into the separate type based on its status from the supply chains.

• Main Enabling Legislation
• Registration
• Classification
• Manufacture
• Distribution
• Use
• Import/Export
• QMS
• Clinical Verification
• Labeling/Packaging
• Adverse Event Monitoring
• Reevaluation/Recall
• Administrative Supervision
• Medical Device Inventory

What does it do?

The MDRGD contains the text of medical device regulations, guidance and related technical measures, as well as the implementation information and the practical know how to comply with it.  The MDRGD enables you to determine the following conditions:

• What product are applicable to China medical device supervision procedures
• What is the legal obligations under CFDA regulations
• The special regulations for overseas applicant
• The data requirements and application dossiers for overseas applicant should be prepared
• The implementation timeline and the deadline
• The background of the regulations (revision history)
• Who are the regulatory authorities for medical device approval of overseas product
• Practical know how to comply with CFDA regulations
• How to prepare the technical files for medical device registration in China.
• Expert suggestions for overseas applicant to acquire the relevant approval from CFDA

How it works?

• Screening the relevant regulations by keywords, supply chain or issuance date
• Select the target regulations and click into,
• View the relevant information: summary, history, timeline, documents and follow up

The MDSSS contains the national standards, industrial standards and technical guideline of medical device in China. The product technical requirement for medical device shall be compiled according to the China related national standard of medical product. It is the most important document for product safety and effectiveness evaluating and the appendix of the medical device registration certificate.

Whatdoes it do?

The MDSSS enables you to search the relevant standards and technical guideline by standards number and name, and apply for the text from CIRS Medical Devices Regulatory Supporting Center (MDRSC).

How it works?

• Input standard number or name;
• View the standard information (number, name, IDT, effective date etc.,);
• Input your email address and send the search request to CIRS experts;
• CIRS expert will keep response to you up your request.

The China Medical Devices Regulatory Supporting Center (MDRSC) provides comprehensive medical devices regulatory support for overseas healthcare product entering into Chinese market. It is supported by CIRS medical device regulatory consulting team. The MDRSC’s primary mission is to provide a network or communication platform for all regulatory activities in China.

MDRSC enables you to acquire the practical advice on how to comply with the medical devices regulations in China and how to export your product into China, and to ensure efficient and effective integration of regulatory information in support of medical device entering into Chinese market.

Disclaimer:

1. CIRS aims to keep the content of this site accurate and up to date. However, CIRS makes no warranties or representations regarding the quality, accuracy, completeness or reliability of information on the site.
2. In no event shall CIRS assume or have any responsibility or liability for any information on this site or for any claims, damages or losses resulting from their use.
3. CIRS reserves the right, at our discretion, to change, modify, add to, or remove portions of information on this site at any time without notice.

Support:

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TEL: +86-571-8720 6541 FAX: +86-571-8720 6533 Mail: Edwin.wen@cirs-group.com