The Guideline on Preparation of Medical Device Technical Requirements

The product technical requirements, we call it product standards also, which mainly involves the performance index and corresponding test method. To compile the product standard, you shall include items as follows:

Name

The name in product standard shall be in Chinese and be consistent with the name in registration or record keeping procedure.

Model and/or Specification

State the definite model and/or specification in the product standard; for the case that there are several models and/or specifications for one registration product, state clearly the difference among models and/or specifications.

Performance Index

The performance index indicated here is the functionality index, safety index and other index relevant to the safety control, and can be objectively determined. The establishment of the performance index shall refer to the national standard/professional standard and in accordance with the design characteristic, intended use and safety control level of the product, and no lower than the applicable national standard/professional standard of the product.

Test Method

When you establish the test method for the corresponding performance index, you may give priorities to adopt the issued certain test method and guarantee the repeatability and operability of the test method; indicate the preparation method of samples if needed, and the diagram is allowed if it has to. For IVD product, you shall specify the used standard substance, the quantity of tested reagents, test numbers and calculation method in the test method as well.

For Class Ⅲ IVD products, the product standard shall include the raw materials, production technique and semi-manufactured goods as appendixes.

Let's take imported class I medical device as an example, the dossier requirements includes:

1. business license
2. overseas listing license
certificate of free sale to overseas(China)
3. production license/GMP
4. EC-certificate
5. technical specification/a methoden of final product test
6. certificate of analysis or self-test report
7. biocompatibility test
8. process description
9. letter of authorisation from the Chinese agent
10. instruction of use
11. primary packaging
12. a letter of commitment from the agent
13. China agent's business license

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