The New Guideline Adds the Following:

1. Performance Requirements
   To establish the performance requirements in the PTR, one can refer to the relevant national standards/industry standards in China, combined with the design characteristics and intended use of the products, and must comply with the mandatory national/industry standards applicable to the products. If the characteristics of the product's structure, intended use, use, etc. are inconsistent with the scope of application of the mandatory standard, the applicant must provide an explanation of the inapplicability of the mandatory standards and the relevant information.

2. Appendix
   For medical devices, if necessary, some descriptive characteristics can be covered in the appendix. Relevant items may include sterile or non-sterile supply status of the product, expiration date, main raw materials, production process, safety characteristics, main specifications, key component information, compatibility, etc.

3. Content Specified in the PTR is Not Recommended
   (3.1.) Research and Evaluation Content:
   The research content is usually a combination of experiments and analysis to study the characteristics of the product. It is generally a verification activity to determine a specific property of the product during the product design and development stage. This includes validity studies, sterilization validation studies, fatigue studies, in vitro degradation studies, human factor validation studies, reliability validation studies, magnetic and resonance compatibility studies, etc.

   Evaluative content generally refers to an assessment of the suitability, suitability, and/or effectiveness of your products for their stated purposes, such as biocompatibility research, stability assessment items, virus inactivation evaluation, immunogenicity evaluation, etc.

   (3.2.) Content Relevant to Unfinished Products:
   The performance requirements and characteristics of raw materials and semi-finished products are generally recommended to be reflected in the PTR. For example, the mechanical properties and chemical properties of the raw material.

New Link:
https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220209152322130.html

Type Approval Impacted

Medical
Approval Process Impact: Yes
Importation Process Impact: N.A
Type of Product Impacted: Technical Requirements