Hot issues in medical device review!

1. Which medical devices do not require clinical trials? 

For the filing of Class I medical device products, clinical trials are not required. For the registration of Class II and Class III medical device products, clinical trials shall be conducted; however, in any of the following circumstances, clinical trials may be exempted:

(1) The working mechanism is clear, the design is finalized, the production process is mature, the same type of medical device has been on the market for many years with no record of serious adverse events in clinical applications, and the conventional use is not changed.

(2) The safety and effectiveness of the medical device can be demonstrated through non – clinical evaluation.

(3) The safety and effectiveness of the medical device can be demonstrated through the analysis and evaluation of data obtained from clinical trials or clinical use of medical devices of the same variety. The catalog of medical devices exempt from clinical trials shall be formulated, adjusted, and announced by the food and drug supervision and administration department of the State Council.

2. What are the requirements for enterprises to conduct clinical trials?

When conducting medical device clinical trials, it shall be carried out in qualified clinical trial institutions in accordance with the requirements of the Good Clinical Practice for Medical Devices, and be filed with the food and drug supervision and administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial sponsor is located. The food and drug supervision and administration department that accepts the clinical trial filing shall notify the food and drug supervision and administration department and the health and family planning department at the same level where the clinical trial institution is located of the filing situation.

3. The puncture device with code 02-12-01 is not listed in the clinical exemption catalogue. Can it be exempted from clinical trials?

According to the “Announcement of the National Medical Products Administration on Announcing the Newly Added and Revised Catalogues of Medical Devices Exempted from Clinical Trials (No. 91, 2019)”, all Class II passive products under Sub-catalogue 02 are exempted from clinical trials. Products with new structural designs that do not generate new risks or reduce the risk level can be exempted from clinical trials. Exclusions include products with new mechanisms of action and drug-device combination products.

4. Does the registered product within the non-clinical catalog need to undergo a comparative evaluation?

Yes.

5. For comparison of the same product type, should we consider products that are within the validity period throughout the entire review cycle, or is it sufficient that the products are within the validity period when the registration is submitted?

When accepting the product registration application, it is sufficient that the registration certificate of the same type of product is within its validity period.

6. The Pharmacopoeia of the People’s Republic of China (2020 Edition) came into effect on December 30, 2020. Do products accepted before this date need to be tested according to the new version? If so, can a self-inspection report replace the type inspection report?

Registration applications accepted since December 30, 2020 shall comply with the Chinese Pharmacopoeia (2020 Edition) and provide inspection reports. The inspection reports provided shall meet the requirements of the Regulations on the Supervision and Administration of Medical Devices.

7. For dressing products not included in the 2017 Classification Catalogue, which have been registered as Class II products in other provinces and have obtained certificates, is classification determination required for declaration in Jiangsu Province?

Yes.

8. Can the results of sterility testing replace the packaging integrity testing?

Irreplaceable. For the integrity of packaging, the results of sterility testing are just one aspect.

9. When submitting a registration for a product that has already obtained a registration inspection report, and the name of the product has been revised in the clinical trial exemption catalogue announced by the National Medical Products Administration, does the enterprise need to update the product name completely when submitting the materials?

The name of the declared product only needs to comply with the “Rules for Naming General Names of Medical Devices”.

10. When renewing the registration, if the recommended standard being referenced has been invalidated and there is a replacement standard, can this standard still be referenced during the renewal?

Invalid documents. They cannot be cited further.

11. Can passive single – use products be changed to reusable products?

In principle, it should be declared for registration as a new product.

12、 If there are products with registration certificates or filing certificates purchased from outside in the packaged products, is it necessary to set requirements for their performance indicators?

For products purchased from external sources that have a registration certificate or filing voucher in package – type products, it should be specified in the technical requirements that they have a medical device registration certificate or filing voucher, and there may be no requirements for their performance indicators. For components in active products (which achieve their functions independently), if they are purchased from external sources and have a registration certificate or filing voucher, the same shall apply.

13. When registering a new product, if an enterprise already has a biocompatibility report for a product with the same material, can the biocompatibility test be waived?

Yes, but you need to submit the original test report that meets the requirements.

14. If the finished product has undergone biological testing, is it necessary to conduct biological testing on the raw materials?

It is not necessary. If the raw materials have undergone biological testing and there is no modification process, the finished product also does not need to undergo biological testing.

15. Considering the supply risk, several component suppliers are to be selected simultaneously. Can only the components from one supplier be tested during product inspection?

It is possible to register only the components from one supplier and specify the supplier during the registration. When adding component suppliers after registration, the enterprise should establish relevant change procedures, which should comply with the requirements of the Good Manufacturing Practice for Medical Products. (Not applicable to in vitro diagnostic reagents)

16. Does the full performance test include biological tests?

Full performance testing does not include biological tests.

17. For products that have already obtained the registration inspection report, is it necessary to conduct re-testing in accordance with the requirements of the technical review guidelines issued subsequently?

It should be subject to the acceptance time of registration declaration. If the acceptance time is after the release of the guiding principles, the new guiding principles shall be implemented.

18.Can the reports of physical and chemical property tests and biocompatibility tests be from different testing institutions?

Yes.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com