The newly revised Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No. 739; hereinafter referred to as the “Regulations”) will come into force on June 1, 2021. The National Medical Products Administration of China (hereinafter referred to as “NMPA”) is organizing the formulation and revision of the supporting regulations, normative documents and technical guidelines, which will be released successively in accordance with established procedures. Following are announcements pertaining to the implementation of the "Regulations":
I About the Registration and Recordation of Medical Devices
According to the new Regulations, from June 1, 2021, all enterprises and medical device researchers and manufacturers that have a medical device registration certificate or put Class I medical devices on record shall perform the duties pertaining to medical device registration and recording, strengthen quality management throughout the life cycle of medical devices and take responsibility for the safety and effectiveness of medical devices in the entire process of R & D, production, operations and use.
II About Medical Device Registration and Recordation Management
Before the promulgation and implementation of the supporting regulations on registration and recording in the new "Regulations," medical device registration and recording applicants shall continue to register and record medical devices in accordance with the current regulations from June 1, 2021. The requirements for clinical evaluation of medical devices shall be observed in accordance with Article 3 of this announcement. The medical products regulatory authorities shall handle the registration and recording in accordance with the procedures and time limits stipulated in the current regulations.
III About Management of Clinical Evaluation of Medical Devices
From June 1, 2021, entities that apply for registration or recording of medical devices shall conduct clinical evaluations in accordance with the new "Regulations." Those that meet the requirements for exemption from clinical evaluation stipulated in the new "Regulations" can be exempted from clinical evaluation. Those that need to conduct clinical evaluation shall carry out clinical trials in terms of product features, clinical risks and existing clinical data etc. or conduct an analysis or evaluation of the clinical literature and clinical data of the medical devices of the same category to prove the safety and effectiveness of the medical devices. For medical devices that cannot be proven safe or effective due to insufficient clinical literature or clinical data, clinical trials shall be carried out. Before the promulgation or implementation of the relevant documents pertaining to exemption from clinical evaluation, the current catalogue of medical devices that are entitled to exemption from clinical evaluation shall be used.
IV About Medical Device Manufacturing License and Recording Management
Before the promulgation and implementation of the relevant provisions on production licensing and recording in the new "Regulations," medical device registration and recording shall proceed in accordance with the existing regulations and normative documents about production licensing, recording and entrusted production.
V About Medical Device Operating License and Recording Management
Medical device registration and recording applicants that sell their registered and recorded medical devices at their domicile or manufacturing premise do not need to apply for medical device operating license or recording, but should meet the prescribed business conditions. Those that store or sell Class II or III medical devices in other places should apply for medical device operating license or recording in accordance with the regulations.
NMPA has drafted a catalogue of Class II medical devices that are entitled to exemption from operating licensing or recording, for which the NMPA is soliciting public comments. The catalog shall come into effect after it is released.
VI About Investigation and Punishment of Illegal Acts Pertaining to Medical Devices
Violations that occur before June 1, 2021 shall be dealt with in accordance with the pre-revised "Regulations." But acts that are deemed not to be illegal or severe under the new “Regulations” shall be dealt with in accordance with the new "Regulations." Violations that occur after June 1, 2021 shall be dealt with in accordance with the new "Regulations."
Above are announcements pertaining to the implementation of the "Regulations."
The National Medical Products Administration of China
May 31, 2021