CFDA Announcement No.144 2014
SYJXG No. 144 [2014]
Issued on August 1, 2014
All food and drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government:
Provisions for Medical Device Registration (CFDA Decree No. 4) and Provisions for IVD Registration (CFDA Decree No. 5) (hereinafter uniformly referred to as the “Provisions”) have been issued, which shall come into force as of October 1, 2014. In order to implement the Provisions, relevant issues are hereby announced as follows:
1 Publicity and training of the Provisions
The food and drug regulatory authorities at all levels shall earnestly carry out the Provisions, strengthen the publicizing and training of the Provisions, pay attention to the important situations and problems encountered in carrying out the Provisions, and promptly communicate with and feed back to CFDA.
2 Disposal of the projects approved for registration before the implementation of the Provisions
For the Class II and Class III medical devices approved for registration prior to October 1, 2014, the Registration Certificate shall continue to be effective within its validity period and the instruction for use and original label of medical devices registered and inspected may continue to be used.
When applying for registration renewal, the registration applicant shall submit application materials in accordance with the Provisions, and simultaneously submit original copy of Standard for Product Registration, product technical requirements and the description on comparison between product technical requirements and former Standard for Product Registration as well as design sample of the labels of minimum marketing unit. Those reviewed and approved for registration, Registration Certificate for Medical Device in new format shall be granted, and the serial number of Registration Certificate shall be re-prepared in accordance with the format specified in the Provisions.
When applying for registration renewal, the registration applicant shall prepare the instruction for use and labels in accordance with Provisions for IFU and Label of Medical Devices (CFDA Decree No. 6) newly revised. Where there is change in the instruction for use compared with that of medical devices registered and inspected, the description on comparison of changes, etc. shall be provided.
For the Registration Certificate within its validity period with changes to content indicated in the former Registration Certificate and changes to in vitro diagnostic reagents, the change application or re-registration shall be applied in accordance with the regulations of former Provisions for Medical Device Registration (SFDA Decree No. 16) and Provisions for IVD Registration (Interim) (CFDA No. 229 [2007]) prior to October 1, 2014; since October 1, 2014, registration change shall be applied in accordance with corresponding regulations of the Provisions. For those approved for changing, the change document of medical device registration in new format shall be granted, which shall be used in combination with former Registration Certificate for Medical Device without changing the serial number of Registration Certificate.
Where the change is applied in accordance with former Provisions prior to October 1, 2014, and the change is approved after October 1, 2014, the change document of medical device registration in new format shall be granted, which shall be used in combination with former Registration Certificate for Medical Device without changing the serial number of Registration Certificate.
3 Disposal of the projects of registration application accepted before the implementation of the Provisions
Where the registration of Class II and III medical devices accepted by food and drug regulatory authorities at all levels while the approval decision has not yet made before the implementation of the Provisions, they shall continue to be inspected and approved in accordance with former Provisions. For those approved for registration, the Registration Certificate for Medical Device shall be granted in accordance with the format specified in the Provisions, in which the “Product technical requirements” in “Annex” Column of Registration Certificate shall be changed to “Standard for Product Registration”. The Standard for Product Registration re-checked shall be sealed with standard re-checking seal and granted as the annex of Registration Certificate. For the Registration Certificate within its validity period, the original instruction for use and original labels registered and inspected may continue to be used.
Where the registration is accepted before the implementation of the Provisions and approved after the implementation of the Provisions, the application of registration renewal and registration change shall be carried out in accordance with relevant regulations in “II Disposal of the projects approved for registration before the implementation of the Provisions” in this document.
4 Registration testing
4.1 Disposal of the projects with registration testing report issued before the implementation of the Provisions
Where registration testing report is issued before the implementation of the Provisions, applicants may submit the registration testing report and pre-evaluation comments on Product Standard as registration application materials and simultaneously submit other application materials such as product technical requirements in accordance with the requirements in the Provisions.
4.2 Disposal of the projects with registration testing accepted before the implementation of the Provisions
Where the registration testing is accepted but registration testing report has not yet been issued before the implementation of the Provisions, applicants shall supplement the documents such as product technical requirements to testing institutions in accordance with the requirements in the Provisions, and testing institutions shall carry out inspection and issue registration testing report in accordance with the requirements in the Provisions.
5 Time of application for registration renewal
5.1 Since April 1, 2015, for those failing to submit application for registration renewal 6 months prior to the expiration of validity period of Registration Certificate for Medical Device, food and drug regulatory authorities shall not accept their application for registration renewal. Applicants shall apply for registration in accordance with the provisions both in Chapter V of Provisions for Medical Device Registration and Chapter VI of Provisions for IVD Registration.
Since April 1, 2015, applicants shall apply for registration renewal 6 months prior to the expiration of validity period of Registration Certificate for Medical Device. The food and drug regulatory authorities accepting registration renewal shall make the decision prior to validity period of Registration Certificate for Medical Device. The decisions made overdue shall be regarded as approval for the registration renewal.
5.2 Prior to April 1, 2015, registration renewal and registration change may be applied in combination and application materials shall be submitted in accordance with the requirements for registration renewal and registration change.
Since April 1, 2015, registration renewal and registration change shall be applied respectively and relevant materials shall be submitted in accordance with corresponding requirements in the Provisions.
6 Relevant documents on administration of medical device registration
6.1 After the implementation of the Provisions, the relevant documents on administration of medical device registration listed in the annex shall be simultaneously abolished.
6.2 For the matters not involved in the Provisions, if there are clear provisions in the documents (including documents issued by CFDA and those issued by the office of CFDA) on administration of medical device registration issued by CFDA (including former SFDA and former State Drug Administration) and the documents are still valid, then former Provisions shall still be implemented.
7 Other matters
7.1 Connection of corresponding contents before and after the implementation of the Provisions
7.1.1 Where the requirements for manufacturers are involved in relevant documents on administration of medical device registration before the implementation of the Provisions, they refer to the requirements for applicants, the registration applicant and filing applicants in the documents after the implementation of the Provisions.
7.1.2 Where clinical trial data are involved in the documents before the implementation of the Provisions, they are replaced by clinical evaluation data in the documents after the implementation of the Provisions.
7.1.3 Where Standard for Product Registration is involved in the documents before the implementation of the Provisions, they are replaced by product technical requirements in the documents after the implementation of the Provisions.
7.1.4 Where the matters are required to be fulfilled in re-registration in the documents before the implementation of the Provisions, they shall be fulfilled in registration renewal after the implementation of the Provisions.
7.2 Guiding principles for the technical review of medical device product registration
For the guiding principles for the technical review of medical device product registration developed and issued by CFDA before the implementation of the Provisions, applicants and food and drug regulatory authorities may continue to refer to technical content thereof and simultaneously conduct registration in accordance with the requirements in the Provisions.
7.3 Clinical trials of in vitro diagnostic reagents
7.3.1 Clinical trial institutions
Prior to the issue of Catalogue of Clinical Trial Institutions of Medical Devices by CFDA, applicants shall carry out clinical trials of in vitro diagnostic reagents at medical and health institutions at provincial level.
For the products with special intended use, clinical trials of in vitro diagnostic reagents may be carried out at Centers for Disease Control, special hospitals or inspection and quarantine office and detoxification centers, etc. at municipal level and above conforming to the requirements.
7.3.2 Start time of clinical trials
After the implementation of the Provisions, clinical trials of in vitro diagnostic reagents shall be carried out after the registration testing is qualified. Where the Clinical Trial Agreement has been executed before the implementation of the Provisions, the clinical trial report carried out prior to registration testing shall be submitted as registration application materials, and the Clinical Trial Agreement shall be simultaneously submitted.
7.4 Import medical devices and the medical devices manufactured in China
The registration applicant and filing applicant of medical devices shall be the enterprises legally registered.
The registration application or filing for import medical devices shall be carried out by overseas applicants (filing applicants); the registration application or filing for the medical devices manufactured in China shall be carried out by domestic applicants (filing applicants).
7.5 Inapplicable clauses
After the implementation of the Provisions, Item (1) and (2) under Article 1 and Article 2 in Announcement of Relevant Issues on Change Review of Partial Medical Devices and Adjustment of Examination Responsibilities of Quality Management System by CFDA (SYJXG No. 28 [2013]) are no longer applicable.
Annex: List of Abolished Documents
China Food and Drug Administration
August 1, 2014
SYJXG No. 144 [2014]
