The new guideline adds the following:
1. Performance requirements
To establish the performance requirements in the PTR can refer to the relevant national standards/industry standards in China, combined with the design characteristics and intended use of the products, and should comply with the mandatory national/industry standards applicable to the products. If the product structure features, intended use, usage, etc. are inconsistent with the scope of application of the mandatory standards, the applicant shall provide an explanation of the inapplicability of the mandatory standards and the relevant information.
For medical devices, if necessary, some descriptive characteristics can be addressed in the appendix in detail. Relevant items may include sterile or non-sterile supply status of the product, expiration date, main raw materials, production process, safety features, key technical specifications, key component information, MRI compatibility, etc.
3. The content specified in the PTR is not recommended
(3.1.) Research and evaluation content:
The research content is generally a combination of experiments and analysis to study the characteristics of the product. It is further usually 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 resonance compatibility studies, etc.
Evaluative content generally refers to an evaluation of the suitability, adequacy and/or effectiveness of a product for its stated objectives, such as biocompatibility research, stability evaluation items, virus inactivation effect evaluation, immunogenicity evaluation, etc.
(3.2.) Content relevant to non-finished products:
The performance requirements and characteristics of raw materials and semi-finished products are generally not recommended to be reflected in the PTR. For example, the mechanical properties and chemical properties of raw material.