NMPA released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, elaborating the risk-based approach for medical device registration review.

Article 13 of “Administrative Measures for Medical Device Registration and Filing” stipulates: “Medical device registration and filing shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of medical device safety and performance, and refer to relevant technical guidelines to prove that the medical devices are safe, effective, and quality controllable, ensuring the authenticity, accuracy, integrity and traceability of the entire process information.”

How to Use the Guideline

NMPA indicates the general requirements for all medical devices and the procedures to use the guideline:

• Determine the applicability and the method used to demonstrate compliance

The registration applicant shall determine the applicability of the specific requirements of the Basic Principles according to the “Applicable Products” column based on the product characteristics. For applicable requirements, during product development, applicant shall first refer to the standards or guidelines given in the column “Methods for Proof of Compliance”, Company-defined methods, generally accepted test methods, comparison of predicate products are also acceptable.

• Form the corresponding compliance evidence based on the determined method

For the evidence that may be involved in each article, the guideline provides two scenarios, and lists the name of the specific application information file based on the evidence:

objective evidence to prove compliance included in registration application materials

objective evidence to prove compliance not included in registration application materials

• Arrange the formed compliance evidence into registration application materials

The registration applicant will organize the objective evidence to prove the compliance to form the registration application materials. The evidence is included in the product registration application materials, and its specific location in the application materials should be stated. If the evidence is not included in the product registration application materials, the name of the evidence file and its serial number in the quality management system file shall be indicated for reference.

The objective evidence to prove compliance in the guideline lists all the evidence that may be involved in medical devices. For different products, the evidence involved may be different, and all the evidence listed in the Guidelines are not necessarily required.

If the evidence contained in the product registration application materials in the guidelines involves usability research, the registration applicant should carry out corresponding research in the product development process under the control of the quality management system. Products with clear requirements for usability research (such as guiding principles, review points, etc.) need to be submitted in the registration application materials.

For an English copy of the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, please email info@ChinaMedDevice.com. Chúng tôi tính phí danh nghĩa cho bản dịch.

For NMPA officials’ opinion on submission material requirements, please click nhấp vào ĐÂY