China medical device standards update plan 2023 has been announced by the National Medical Products Administration (NMPA).
Each year the NMPA identifies medical device industry standards that require revision or need to be developed. In 2023, the NMPA has identified 117 medical device industry standards for revision amongst which there are a few which are to be developed from scratch.
The medical device industry sectors affected are vast:
- from dentistry to ophthalmology,
- from medical imaging to cardiology.
Why are these standard updates important?
The objective of the standards revisions is to streamline the procedures for manufacturers to conduct local type testing and submit regulatory documents, while ensuring alignment with international standards. Industry Mandatory Standards are legally binding and must be adhered to. The Decree 739 Regulation on Supervision and Management of Medical Devices, which serves as the primary legislation governing the medical device industry in China, mandates that medical devices should meet the national mandatory standards. In cases where national mandatory standards are not available, compliance with industry mandatory standards is required.
On the other hand, industry-recommended standards are not legally binding but are suggested by regulatory authorities. Whether you are renewing your registration or submitting a new one, it is necessary for your medical devices to meet these updated standards. Even if there are no changes in your renewals (which are mandatory every 5 years according to the NMPA), you still need to demonstrate that your originally approved products comply with the new standards. Consequently, your initially approved products will still undergo local type testing to ensure conformity with the revised standards. And this type testing for the new industry standard will need to commence in advance of any registration renewal process to avoid any disruption in supply of your product to China.
If your products are due to have their industry standard updated, please reach out to your Cisema consultant for further advice. Discover our services for medical device registration, renewals and NMPA Legal Agent.