The revised Regulations for the Supervision and Administration of Medical Devices (State Council Order No.739, hereinafter referred to as the Regulations) will be implemented as of June 1, 2021. NMPA is organizing the formulation and revision of supporting regulations, normative documents and technical guidances, which will be released one after another in accordance with procedures. The matters related to implementation of the new Regulations are hereby announced as follows:
I. Full Implementation of the Medical Device Registrantand Filing Applicant System
As of June 1, 2021, the enterprises and the medical device R&D institutions, which have obtained the medical device registration certificate or have filed Class I medical devices, shall fulfill the obligations of medical device registrant and filling applicant respectively, strengthen the quality management over the whole life cycle of medical devices, and bear responsibilities for the safety and effectiveness of medical devices in the process of R & D, manufacture, distribution and use in accordance with the new Regulations.
II. Registration and Filing of Medical Devices
As of June 1, 2021, prior to the issuance and implementation of relevant provisions on registration and filing supporting the new Regulations, medical device registrants and filing applicants shall continue to apply for registration and conduct filing in accordance with the current provisions. The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article III of this Announcement. Medical products administration shall carry out the registration and filing in accordance with the currently specified procedures and time limits.
III. Clinical Evaluation Management of Medical Devices
As of June 1, 2021, medical device registrants and filing applicants shall carry out clinical evaluation in accordance with the new Regulations. Clinical evaluation may be exempted for those complying with the provisions for exemption from clinical evaluation in the new Regulations; for the purpose of performing clinical evaluation, it is feasible to prove the safety and effectiveness of the medical device by carrying out clinical trials according to the product characteristics, clinical risks and the existing clinical data or by performing analysis and evaluation on the clinical literatures and clinical data of predicate medical devices; clinical trials shall be carried out for medical devices whose safety and effectiveness cannot be proved by the existing clinical literatures and clinical data. Prior to the issuance and implementation of relevant documents on exemption from clinical evaluation, the current Catalogue of Medical Devices Exempted from Clinical Trials shall be referenced for the Catalogue of Medical Devices Exempted from Clinical Evaluation.
IV. Production Licensing and Filing Management of Medical Devices
Prior to the issuance and implementation of relevant provisions on production licensing and filing supporting the new Regulations, medical device registrants and filing applicants shall handle the production licensing, filing and entrusted production in accordance with the existing rules and normative documents.
V. Distribution Licensing and Filing Management of Medical Devices
Medical device sold by its registrant and filing applicant at their residence or manufacturing site may not apply for medical device distribution licensing or filing, but shall comply with the specified distribution conditions; for Class II and Class III medical devices stored and sold at other sites, application for medical device distribution licensing or filing shall be made as required.
NMPA has drafted a Catalogue of Class II Medical Devices Exempted from Distribution and Filing, for which public comments are currently solicited. After being issued, the Catalogue shall be executed.
VI. Investigation and Punishment of Illegal Acts of Medical Devices
Where an illegal act of medical device occurs before June 1, 2021, the Regulations before revision shall apply. However, if the act is not considered illegal or the punishment is relatively light according to the new Regulations, the new Regulations shall apply. Where an illegal act occurs after June 1, 2021, the new Regulations shall apply.
It is hereby announced.