The China medical device mandatory standards list has been updated, and the Center for Medical Device Evaluation (CMDE) of the NMPA (National Medical Products Administration) addressed the responsibilities of medical device certificate holders in accordance with the scope of mandatory standards.
The position has thereby been clarified for medical device certificate holders where the mandatory standard is implemented but has otherwise no impact on the existing registration certificate.
On November 18, 2022, the CMDE issued a list of medical device mandatory standards (hereinafter the CMDE List). The CMDE List uses a similar framework of the official medical device classification catalogue to indicate the corresponding mandatory national standards and industry standards of medical devices.
According to the instructions provided by the CMDE, medical device certificate holders should apply for registration modification if the corresponding medical device mandatory standard have any implemented changes falling under the requirements of the Administrative measures for the registration and filing of medical devices. For any changes to mandatory standards applicable to products not covered in the CMDE list, certificate holders are still advised by the CMDE to meet the new mandatory standard requirements.
However, if a new corresponding mandatory standard is implemented but causing zero impact towards the registration certificate itself or certain notable items, medical device certificate holders will not need to apply for registration modification. For instance, the following examples are provided by the CMDE as a reference to two case scenarios when the application of registration modification won’t be necessary:
- The product technical requirements (PTR) for the medical device remains unchanged by the new mandatory standard
- The new mandatory standard only changes the code referencing the year and/or the standard code
For cases when a product cannot be identified in the CMDE List by its name, but could be identified by its product performance, the contents of the actual declaration information may prevail, otherwise, the certificate holder may proceed with the declaration of registration in accordance with the applicable mandatory standard.
Since the China regulatory landscape is ever-changing, the CMDE List will be updated whenever there is new mandatory standard or change in the existing mandatory standards for medical devices. Contact Cisema if you would like to learn more.