NMPA Updated The Medical Device Clinical Evaluation Exempt Catalogue

On July 20, NMPA released the updated “Medical Device Clinical Evaluation Exempt Catalogue” (NMPA, No. 71, 2021) in order to manage the registration of medical devices more effectively.

Major items in this Clinical Evaluation Exempt Catalogue:

• The products that are upgraded to Class II after sterilization in the original catalog of Class I medical devices are exempted from clinical evaluation, if no new risk arises after sterilization or the degree of risk is reduced after sterilization.
• Class II passive devices under the Catalogue Code 02 (Passive surgical instruments), Catalogue Code 03 (Neurological and cardiovascular surgical instruments), Catalogue Code 02 (Ophthalmic Instruments) and Catalogue Code 18 (Obstetrics and gynecology, assisted reproduction and contraceptive devices) are exempted from clinical evaluation. The products are equivalent to the products that have been approved in China, and the product composition materials are mature. But the product with new working mechanism, drug-device combination products are excluded. The products with new structural design that does not generate new risks or reduce the degree of risk can be exempted from clinical evaluation.
• Class II devices under the Catalogue Code 11 (Medical devices for sterilization and disinfection) are exempted from clinical evaluation.
• 21 devices are newly added to this Catalogue.
• 85 devices are revised in this Catalogue.

Please visit China Clinical Evaluation Report (CER) for NMPA Registration | BradyKnows (bradyknowsmedical.com) to do a China CER feasibility self-evaluation or reach out to BradyKnows to check if your devices are exempted from clinical evaluation in China via info@bradyknowsmedical.com.