The NMPA released the “Guideline for Medical Device Product Technical Requirements (PTRs)” on February 9, 2022, directing manufacturers on preparing one of the most important documents submitting to NMPA.
What does NMPA Product Technical Requirements (PTR) Consist of?
Product Technical Requirements (PTRs) can be divided to the following five parts:
- Product model/specification and its classification
The product model and specifications should be specified in the product technical requirements. For products with multiple models and specifications in the same registration unit, the division of different models and specifications should be clarified (recommended in the form of diagrams and/or tables), and content with more text can be listed in the appendix.
For products containing software, the naming rules of software release version and software full version should be clarified.
- Performance indicators
The performance indicators in the product technical requirements refer to the functional and safety indicators of the finished product that can be objectively judged.
Items that do not have a substantial impact on product safety and effectiveness may not be listed in the technical requirements performance indicators. For example, some drainage catheter products mainly focus on their smoothness. The product needs to be able to effectively connect the suction device and the end of use, and ensure that the connection is firm. If necessary, the diameter and length of the catheter can be used as product descriptive information in the appendix of technical requirements. Not as a product performance indicator. Others such as product engineering drawings do not need to be listed in the technical requirements.
However, the dimensional information of some products will have an important impact on their safety and effectiveness, and should be specified in the technical requirements performance indicators, such as the length and outer diameter of vascular stent products, and the dimensional tolerance of orthopedic implants.
- Inspection method
The inspection method is a method used to verify whether the product meets the specified requirements, and the formulation of the inspection method should be adapted to the corresponding performance indicators. Test methods using applicable established standard methods should be prioritized and, if necessary, methodological validation should be performed to ensure the reproducibility and operability of the test methods.
The test method should include the test procedure and the presentation of the results (such as calculation method, etc.). If necessary, all conditions, steps, etc. to ensure reproducible results can also be added to the test principle, sample preparation and storage, instruments, etc.
For in vitro diagnostic reagent products, the test method should also clearly state the reference substance/standard substance used, the sample preparation method, the number of tests, and the calculation method.
- Terminology
- Appendix(es)
Requirements on Performance Indicators
Indicators that can be objectively judged usually refer to indicators that can be quantified or objectively described. For example, the indicator can be directly checked by a certain test method that can verify its characteristic value, and the data result can be obtained directly.
The guideline gives following examples to demonstrate what contents shall be included in the performance indicators:
- Hemodialyzer
- intravascular catheter
- infusion pump
- imaging ultrasonic diagnostic equipment
For more information on the above devices, please contact us at info@ChinaMedDevice.com.
The following contents are not recommended to be specified in the performance indicators:
- shelf life
- sterilization validation studies
- fatigue studies
- in vitro degradation studies
- human factor validation studies
- reliability validation studies
- magnetic resonance compatibility studies
- biocompatibility research
- environmental requirements
- virus inactivation effect evaluation, immunogenicity evaluation and so on.
- contents related to non-finished products
For an English copy of the “Guideline for Medical Device Product Technical Requirements (PTRs)”, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
