These documents shall include information on safety and performance testing that has been conducted to ensure the claimed efficacy, structure, materials, design, and quality of the product.

    Preclinical testing refers to the bench testing performed during product development in order to confirm the safety and performance of the product design, including functionality, electrical safety, electromagnetic compatibility, biocompatibility, sterilization validation, software verification and validation, etc.

    Final Quality Control is the final ex-work testing of products. Such a test report usually differs in format and content by manufacturer and product. The test items usually include product appearance, dimensions, basic safety testing, and functional testing, among others.

    Complete test data shall include the test item, test specifications, test methods, Certificate of Analysis, acceptance range, rationale, and references. The Certificate of Analysis, in particular, shall clearly show the name and specification (model number) of the product, the name and address of the manufacturing plant, and signature of the person performing the test.

    If there are existing standards or guidelines available for such products, provide reports of applicable tests performed as required by said standards or guidelines, as this significantly reduces the possibility of insufficient test data.

    Laboratories that perform the biocompatibility, electrical safety, electromagnetic compatibility, and sterility tests shall meet one of the conditions below:
1. Compliance with the requirements of ISO/IEC 17025.
2. Compliance with the requirements of the Good Laboratory Practice for Nonclinical Laboratory Studies (GLP).