The following represent a number of selected clauses from the new Decree No. 47, which are deemed to be of particular significance in relation to the registration of medical devices in China:
- Innovative medical devices that have not been marketed in the country (region) where the applicant or the filing person is registered, or where the place of production is located, do not need to submit the certification documents for the marketing of the declared product. (Decree No. 47, Article 18)
- The medical device product testing report submitted for registration or filing may be a self-test report of the applicant or filing person, or a testing report issued by a qualified medical device testing agency. (Article 32)
- NMPA has issued the list of medical devices exempted from clinical evaluation. Those selected medical devices, which are exempted from clinical evaluation, may also be exempted from submitting clinical evaluation data. (Article 34)
- Decree No. 47 has added the following special registration procedures: Innovative product registration procedure (Article 68 to Article 72), Priority registration procedures (Article 73 to Article 75), Emergency registration procedures (Article 76 to Article 78).
- In case the design, raw materials, production process, scope of application, or the method of use of a registered Class II or Class III medical device undergoes substantial changes, which may affect the safety and effectiveness of the product, the registrant shall apply to the original registration department for a so-called “change of registration”. However, if there are any other changes, the changes should be filed with the original registration department within 30 days from the date of the change. (Article 79)
- The product name, model, specification, structure and composition, scope of application, product technical requirements, as well as the production address of imported medical devices stated in the registration certificate are the items that need to be registered for change as specified in the preceding paragraph. While the name and residence of the registrant, along with the name and residence of the agent are matters that need to be filed within 30 days as prescribed in the preceding paragraph.
- Yet, in case the domestic medical device production address is changed, the registrant shall file for a record when applying for change corresponding to the production license. (Article 79)
- If a registration renewal is approved within the validity period of the original registration certificate, the start date of the validity period of the renewal registration certificate shall be the following day after the expiration date of the original registration certificate.
- However, if the approval time is not within the validity period of the original registration certificate, the starting date of the validity period of the renewal registration certificate shall be the date when the renewal of registration is approved. (Article 84)
Measures for the Administration of Medical Device Registration and Filing (State Administration for Market Regulation Order No. 47)