Technical Guidelines for Essential Principles of Safety and Performance of Medical Devices were issued on July 12, 2022, by the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA).
These Technical Guidelines have been developed to guide medical device registration applicants to accurately complete the “List of Essential Principles of Medical Device Safety and Performance” in the registration application dossier, which is a general requirement for all medical devices.
The Essential Principles of Medical Device Safety and Performance were issued in March 2020 by the NMPA (hereinafter referred to as the “Essential Principles”). They describe the fundamental design and manufacturing requirements for the registrant / NMPA Legal Agent to ensure the medical device can be operated safely and performs as intended throughout its product life cycle under the control of a quality management system.
The Technical Guidelines
1. Determine applicability
The registrant / NMPA Legal Agent shall determine the applicability of specific requirements of the Essential Principles. This can be done by referring to the column entitled “Applicable Products” in the Technical Guidelines. Not all requirements are applicable to all medical devices, e.g., requirements may be specific to reusable medical devices or those which are implantable, etc.
2. Determine the methods used to prove compliance
Once the applicability to the medical device has been determined, the next step is to identify the applicable methods to demonstrate compliance with the requirements when developing the products. This can be done by reviewing the standards and guidelines listed in the column entitled “Methods used to demonstrate compliance” . Other methods can also be used such as those described in the Announcement on the Publication of Requirements for Registration of Medical Devices and the Format of Approval Certificates (No. 121 [2021]).
3. Generate corresponding conformity evidence in accordance with the determined methods
The registrant / NMPA Legal Agent shall generate corresponding objective evidence during R&D and production in accordance with the determined methods. The Technical Guidelines list the names of specific documentation that shall be used as related evidence in the two columns entitled:
- “objective conformity evidence to be contained in the registration application materials”
- “objective conformity evidence not to be contained in the registration application materials”.
4. Incorporate conformity evidence into the registration application dossier
The registrant / NMPA Legal Agent shall incorporate the objective evidence that proves compliance with the Essential Principles of Safety and Performance of Medical Devices into the registration application dossier as well as referencing the evidence in the “List of Basic Principles for Medical Device Safety and Performance” (hereinafter referred to as the “List”).
If evidence is included in the product registration application dossier, its specific position in the dossier should be stated in the “List “.
If the evidence is not included in the product registration application dossier, the name of the evidence document and its number in the quality management system document shall be indicated in the “List” for future reference.
Further information
If you would like to know how the Essential Principles of Safety and Performance of Medical Devices apply to your products, please contact us.
