Introduction to quality system verification (system assessment)

Article 17 of the regulations on the supervision and administration of medical devices (Decree No. 739 of the State Council of the people's Republic of China on February 9, 2021): the drug regulatory department that accepts the registration application shall review the safety and effectiveness of the medical device and the ability of the registration applicant to ensure the safety and effective quality management of the medical device. The drug regulatory department that accepts the registration application shall transmit the registration application materials to the technical evaluation institution within 3 working days from the date of accepting the registration application. After completing the technical review, the technical review institution shall submit the review opinions to the drug regulatory department that accepts the registration application as the basis for approval. If the drug regulatory department that accepts the registration application considers it necessary to verify the quality management system when organizing the technical review of medical devices, it shall organize the verification of the quality management system.

Basis of quality system verification

On March 10, 2020, the State Food and Drug Administration issued (2020 No. 19) notice "guidelines for the verification of medical device registration quality management system";
1. Objective and basis: in order to strengthen the supervision and guidance of the registration of medical devices and further improve the quality of the verification of the medical device registration quality management system, this guide is formulated in accordance with the administrative measures for the registration of medical devices, the administrative measures for the registration of in vitro diagnostic reagents, the administrative specifications for the production quality of medical devices and their appendices.
2. Scope of application
This guide is applicable to the on-site verification of the class II and class III medical device registration quality management system by the medical device regulatory authorities.
3. Basic principles
(1) This guide should be used on the premise of complying with the medical device production quality management specification and its appendices.
(2) The applicant for medical device registration (hereinafter referred to as the applicant) shall establish a quality management system suitable for the product realization process, ensure its effective operation in the whole life cycle management process of medical devices, ensure that the data of design, development, production and other processes are true, reliable, complete and traceable, and consistent with all registration application materials submitted at the time of registration.
(3) In combination with the registration and application materials, we should focus on the design and development, procurement, production management, quality control and other contents related to product development and production, as well as the authenticity verification requirements.
(4) The verification conclusion is divided into four situations: pass the verification, fail the verification, pass the verification after rectification, and fail the verification after rectification according to the requirements of the working procedure for the verification of the quality management system for the registration of class III domestic medical devices (Provisional).

NCE can provide pre audit services before system verification

As one of the nationally recognized audit institutions of medical device management system standards, we have long been engaged in the service and certification of medical device quality management system. We have the professional knowledge to provide pre audit in a wide range of medical fields. Through the company's professional audit, we can promote enterprises to improve business performance and support sustainable development. For your entrustment, we will arrange a full-time experienced NCE auditor to verify that your business (entrusted products) information, policies and procedures meet the requirements and objectives of your organization in all aspects, including:
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