How to develop standards for medical devices

Manufacturers in the declaration of product registration should be submitted to the drug supervision and management department of the registered product standard text and standard

compilation instructions.

The description of the preparation of standards for registered products should include the following:

(a) whether the materials in contact with the human body have been used in clinical practice, and whether their safety and reliability have been proved;

(b) relevant standards and information cited or referred to;

(c) the basis for determining the management category;

(d) the overview of the product and the basis for determining the major technical provisions;

(d) the product overview and the main (v) Self-test report of the product;

(vi) Other contents that need to be explained.

You Baidu "medical device standards management approach" (for trial implementation) (Bureau Decree No. 31)