Medical Device Product Technical Requirements - New Guideline Issued

Medical device product technical requirements (PTR), as manufacturers will be aware, is equally important as the final NMPA certificate because the PTR is an annexure to the certificate. The PTR also forms the basis for local testing in China.

On February 9, 2022, the NMPA (National Medical Products Administration) announced (No.8-2022) the new guideline for writing the PTR for medical devices.

Highlights on medical device product technical requirements

In general, the PTR covers basic information such as product name, model, product specification, performance indicators, testing methods, terminologies, etc.

According to the new guideline, performance indicators should be measurable or explanable in terms of safety and functionality.

For instance, if the intended use of a hemodialysis product is to remove target substances, the PTR should measure the remained amount of substance to demonstrate the basic functionality of the product.

Further information

If you would like to know how the changes affect your medical device or IVD registrations, renewals or changes, or for details of our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, and industrial or consumer goods, please contact us.