Q Can I get a registration certificate for some products that are not Class II medical devices? For example, upper limb sling, lap belt, full elastic waist belt, etc.

About classification:

Lap belts belong to Class I if they are medical corsets,

The classification of full elastic waistbands depends on what your role is, if it is to assist in the treatment of lumbar spondylosis is classified in Class II.

What is the intended use of your product, you can categorize it in the classified directory based on the intended use.

Second, about the product registration:

One class of product registration is relatively simple, with the production license, product standards audit report, self-test report and other things can prepare the relevant information.

The second type of relatively increased difficulty, need to have a production license, product testing reports, clinical trial data, quality system assessment reports and related personnel site qualification documents can be submitted.