On 15 August 2023, the State Food and Drug Administration under the Centre for Medical Device Evaluation (CMDE) announced the adjustment of some contents for the Medical Device Classification Catalogue (2023 No.101). The rework involves 58 types of medical devices from all classes.
The drug regulatory authority will continue to evaluate medical devices according to the original acceptance category for initial registration or renewal registration that have been accepted for registration and approval prior to the announcement date. However, the validity date will remain until 31 December 2025, and the indications shall be remarked on the registration certificate.
Next, for medical devices obtained the Class II registration certificate, the medical devices will be valid until 30 December 2025. In accordance with the class requirements for medical devices, the sponsors, MAH, or registrants are in charge of proceeding forward with the class-types conversion. The sponsors may request an extension from the authority if a certificate expires during the transition phase, and it will be granted as long as there are no serious adverse events or incidents involving the related medical devices.
In order to prevent any significant safety issues from occurring, no medical devices with no valid Class III registration certificates under the most recent law amendment shall be made, imported, and marketed on the market as of 1 January 2026.
Note that for medical devices Class III that have been adjusted to Class II, according to the latest amendment, the registration certificate is valid within the specified validity period. For any renewal required, 6 months prior to the expiration date, sponsors must submit an application for the registration renewal to the appropriate authority, based on the revised category. Once the approval is issued, the products are allowed for the market with the new class type.
While for medical devices Class II adjusted to Class I, the registration certificates are continuously valid within the specified validity period mentioned above, the registrant can go through the product filling process before the certificate expires.
After all, the registrant shall directly apply for the registration changes, if required, to the registration authority. If the original certificate is issued according to the original Medical Device Classification Catalogue, the adjusted category implemented from the law amendment must be indicated on the new registration certificate.