The newly revised regulations on supervision and administration of medical devices (Order No. 739 of the State Council, hereinafter referred to as the new regulations) will come into force on June 1, 2021. The State Food and Drug Administration is organizing the revision of supporting regulations, normative documents and technical guidelines, which will be released one after another in accordance with the procedures.
The relevant matters concerning the implementation of the new "regulations" are hereby announced as follows:
On the full implementation of the system of medical device registrants and registrants
From June 1, 2021, any enterprise or medical device development institution that holds a medical device registration certificate or has applied for the first type of medical device filing shall, in accordance with the provisions of the new "regulations, fulfill the obligations of medical device registrants and registrants respectively, strengthen the quality management of medical devices throughout the life cycle, and take responsibility for the safety and effectiveness of traditional Chinese medicine treatment devices during the whole process of development, production, operation and use according to law.
Registration and filing management of medical devices
From June 1, 2021, before the relevant provisions on registration and filing of the new "regulations" are issued and implemented, medical device registration applicants and filers will continue to apply for registration and filing in accordance with the current provisions. The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article 3 of this announcement. The drug supervision and administration department shall carry out the relevant work of registration and filing in accordance with the current prescribed procedures and time limits.
Management of clinical evaluation of medical devices
Since June 1, 2021, medical device registration applicants and filers have carried out clinical evaluation according to the provisions of the new "regulations. In accordance with the provisions of the new "regulations", the situation of exemption from clinical evaluation can be exempted from clinical evaluation; Clinical evaluation can be conducted according to product characteristics, clinical risks, existing clinical data, etc, through clinical trials, or through the analysis and evaluation of clinical literature and clinical data of the same variety of medical devices, it is proved that medical devices are safe and effective; Existing clinical literature, if the clinical data is not sufficient to confirm the safety and effectiveness of the product, clinical trials should be carried out. Before the release and implementation of relevant documents exempted from clinical evaluation, the catalogue of medical devices exempted from clinical evaluation shall be implemented according to the current catalogue of medical devices exempted from clinical trials.
Management of Medical Device Production License and filing
Before the release and implementation of the relevant provisions of the production license and filing of the new "regulations", the registration of medical devices and the filing person shall handle the production license, filing and entrusted production in accordance with the existing regulations and normative documents.
Management of medical device business license and filing
Medical device registrants and registrants sell their registered and filed medical devices at their residences or production addresses, and do not need to apply for medical device business license or filing, but should meet the prescribed operating conditions; if the second or third types of medical devices are stored and sold in other places, the medical device business license or filing shall be handled in accordance with the provisions.
The State Food and Drug Administration has drafted a catalogue of category II medical devices that are exempt from business filing, and is currently seeking public opinions. After the product catalog is published, run by catalog.
Investigation and punishment of illegal acts of medical devices
If the illegal acts of medical devices occurred before June 1, 2021, the "regulations" before revision shall be applied, but if it is considered not to be illegal or the punishment is lighter according to the new "regulations", the new "regulations" shall be applied. If the illegal act occurs after June 1, 2021, the new regulations shall apply.
-- State Food and Drug Administration
