Announcement of the National Medical Products Administration on Matters Concerning the Implementation of Measures for the Administration of Registration and Filing of Medical Devices and Measures for the Administration of Registration and Filing of In-Vitro Diagnostic Reagents

The Measures for the Administration of Registration and Filing of Medical Devices (Order of State Administration for Market Regulation (No. 47)) and the Measures for the Administration of Registration and Filing of In-Vitro Diagnostic Reagents (Order of State Administration for Market Regulation (No. 48)) (hereinafter collectively, the Measures) have been issued and will come into force on October 1, 2021. In order to do a good job in implementing the Measures, the relevant matters are hereby announced as follows:
I. About the processing of registration applications accepted before the implementation of the Measures
For registration applications accepted before the implementation of the Measures, for which no approval decisions have been made, medical products administrations should continue the review and approval process according to the original provisions and issue the Registration Certificates for Medical Device to those meeting the conditions for marketing. The provision of Article 84 of the Measures should be implemented for the starting dates of validity periods of registration certificates renewed.
II. About inspection reports involved in the correcting materials
For registration applications accepted before the implementation of the Measures, for which no approval decisions have been made, if inspection reports are involved in the correcting materials, registration applicants should entrust qualified medical device inspection bodies to issue supplementary inspection reports; if registration applicants’ systems cover inspection capacity, they may submit supplementary self-inspection reports according to the Measures and relevant requirements.
III. About the review of registration applications accepted before the implementation of the new mandatory standards
For medical devices applied for registration, if the mandatory standards referenced in their product technical requirements change, unless otherwise stipulated by the National Medical Products Administration in the standard documents issued, those whose registration applications are accepted before the implementation of the new standards may be reviewed and approved according to the original standards, however, from the dates the new standards come into force, enterprises should fully implement the new standards, with their products meeting the requirements thereof.
IV. About the biological tests for medical devices
If biological tests are involved in the biological evaluations of medical devices, the biological test reports should be submitted by applicants at the time of applying for registration as research data. Medical device inspection bodies with biological test qualifications should be entrusted to conduct biological tests according to the relevant standards. Biological test reports issued by foreign laboratories should be attached with quality assurance documents of the foreign laboratories showing their compliance with GLP requirements.
V. About the form of registration (filing) of imported medical devices and medical devices produced in China
For imported medical devices, foreign registration applicants (filing parties) should apply for registration (process filing); for medical devices produced in China by foreign enterprises, the producers in China should apply for registration (process filing) as registration applicants (filing parties).
VI. About the filing of Class I medical devices
Clinical evaluation data is not required for the filing of Class I medical devices.
VII. About documents related to the administration of registration of medical devices
(I) The documents related to the administration of registration of medical devices as listed in the attachment will be abolished after the Measures come into force.
(II) For matters not covered in the Measures, if there are explicit provisions in the documents concerning the administration of registration of medical devices previously issued by the medical products administration of the State Council, the original provisions should be implemented.
 It is hereby announced.

Attachment: List of Abolished Documents

                              National Medical Products Administration
                            September 28, 2021

Attachment of Announcement No. 76 of 2021 of National Medical Products Administration.docx