The Center for Medical Device Evaluation (CMDE) is the center for reviewing medical device registration dossier under the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). The CMDE performs the technical evaluation of medical devices. Its role is quite similar to the Center for Devices and Radiological Health (CDRH) at the FDA in the USA. Each one is responsible for reviewing registrations of different categories of medical devices/IVDs.

What are the Various Departments Within the CMDE?

There are three (03) main departments in the CMDE.

  • Quality Management Department is responsible for formulating the medical device review system and supervising its implementation. Coordinate the formulation and revision of technical guidelines for medical devices. Guide the construction of the Quality Management System (QMS) for local review institutions. Undertake other tasks assigned by the center.
  • Compliance Department is responsible for the preparation and issuance of medical device review reports. Organize and coordinate business guidance and technical support for local medical device technical review. Coordinate medical device product registration Quality Management System (QMS) verification and clinical trial verification.  Organize and carry out the review of special approval applications for innovative and priority medical devices.
  • Project Management Department is responsible for the acceptance and data management of medical device registration applications and  the review of medical device renewal registration and simple change registration applications. Organize and implement the filing review, project management system, and project team review system and supervise the progress of the review. Organize and carry out communication with administrative counterparts.

What are the Major Responsibilities of the CMDE?

The CMDE is responsible for the following:

  • Acceptance and technical review of domestic Class III medical device products and imported medical device products applying for registration (Class II/III); responsible for the filing of imported Class I medical device products.
  • Participate in the drafting of laws, regulations, and normative documents related to medical device registration management. Organize the formulation of relevant medical device technical review specifications and technical guidelines and organize their implementation.
  • To undertake the technical review of medical devices involved in emerging medical products such as regenerative medicine and tissue engineering.
  • Coordinating inspection work related to medical device review.
  • Carry out research on theories, technologies, development trends, and legal issues related to medical device review.
  • Responsible for providing business guidance and technical support for local medical device technical review work.
  • Organize relevant business consultation and academic exchanges and carry out international (regional) exchanges and cooperation related to medical device review.
  • Undertake other matters assigned by the State Bureau.

Does the CMDE Investigate the Post-market Surveillance (PMS) Activities of Approved Medical Devices?

Yes, the CMDE conducts Post-market Surveillance (PMS) and inspection activities to ensure that medical devices continue to meet safety and efficacy requirements after they have been approved for use.

What are the Additional Responsibilities of the CMDE?

In addition to its Regulatory responsibilities, the CMDE also plays an important role in promoting the development of the medical device industry in China. It works closely with industry stakeholders to encourage innovation and the development of new products, and it provides guidance and support to medical device manufacturers throughout the product development process.

Overall, the CMDE plays a critical role in ensuring the safety and effectiveness of medical devices in China, and it is an important Regulatory Body for medical device manufacturers who wish to sell their products in the Chinese market.

To decode more about medical device registration in China, reach out to an experienced Regulatory expert now! Stay informed. Stay compliant.