What medical device products can be exempt from registration inspection?

For the registration of Class II and Class III medical devices, if the following conditions are met simultaneously, registration testing can be waived:

1. The basic principles, main functions, structures, materials used, material qualities, and intended uses of the medical device applied for registration are of the same category as those of the medical device already approved for registration by this enterprise.

2. The manufacturing enterprise has passed the inspection of the Good Manufacturing Practice for Medical Devices or obtained the medical device quality system certification, and the manufacturing enterprise can provide a test report recognized by the original enterprise production condition review agency.

3. When comparing the medical device applied for registration with the similar products of the enterprise that have been approved for registration and have passed the registration inspection, no changes involving safety and effectiveness have occurred. Or, although changes involving safety and effectiveness have occurred, both the changed parts and the parts of the product’s other relevant safety and effectiveness changes caused by them have passed the inspection by the medical device testing institution.

4. The similar products of our enterprise that have been approved for registration shall conduct medical device adverse event monitoring in accordance with regulations, and no serious adverse events have been found.

5. There have been no records of unqualified product quality supervision and spot checks by the (food) drug supervision and administration department within one year for similar products of this enterprise that have been approved for registration.

6. The overseas medical device has obtained the marketing approval from the medical device regulatory department of the overseas government. Does a Class I medical device product need to undergo registration testing?

The overseas medical device has obtained the marketing approval from the medical device regulatory department of the overseas government. Does a Class I medical device product need to undergo registration testing?