Starting from June 1st, the new regulations for medical devices will be implemented

01

New regulations released, new changes in commissioned production of medical devices

Recently, NMPA issued the Announcement (No. 38 of 2024) on Further Strengthening the Supervision and Management of Production Commissioned by Medical Device Registrants (hereinafter referred to as the Announcement), which will come into effect on June 1, 2024

Since 2017, various regions such as Shanghai, Guangdong, and Tianjin have successively promoted the pilot work of medical device registrants, and subsequently the pilot work has been widely launched. In June 2021, the new version of the Medical Device Supervision and Administration Regulations was officially implemented, marking the full implementation of the medical device registration system.
In this context, medical device registrants and filers can produce medical devices themselves, or entrust enterprises that meet the requirements of the new regulations and meet the corresponding conditions to produce medical devices.

In the latest Announcement, the requirements for production supervision commissioned by medical device registrants are further refined. Among them, it is clear that the main responsibility of medical device registrants shall be strictly implemented; the registration management of entrusted production of medical devices shall be strengthened; and the supervision and management of entrusted production shall be continuously strengthened.

The Announcement once again clarifies that the registrant shall fully implement the main responsibility for the quality and safety of medical devices, establish a quality management system that covers the entire life cycle of medical devices, and maintain effective operation.

If the registrant entrusts production, it shall establish and improve a management organization that is suitable for the characteristics of the products and the scale of the enterprise entrusted for production, fully fulfill the responsibilities of product risk management, change control, product release, after-sales service, product complaint handling, adverse event monitoring, and product recall, and regularly review the operation of the quality management system of the entrusted production enterprise in accordance with the medical device production quality management standards.

The registrant shall give priority to selecting enterprises with high quality management level, large production scale, good credit record, high level of production automation and information management as the trustee.

02

Comprehensive investigation and unified inspection scale

In areas with relatively concentrated registrants for commissioned production, provincial Medical Products Administration should regularly hold special consultations on the supervision of commissioned production by registrants based on the progress of regulatory work, analyze the results of supervision and product sampling, comprehensively investigate safety hazards in the enterprise’s quality management system and product quality, take targeted prevention and control measures, and eliminate systemic and regional risks.

Medical products administrations are encouraged to explore the synchronization of supervision and inspection at both sites of the registrant and the entrusted manufacturing enterprise, and to communicate timely inspection information and unify the inspection yardstick by means of information technology, such as connecting the inspection site through the network in a remote manner.

In addition, if it is found during the inspection that the quality management system of the registrant or entrusted production enterprise is not effectively operating, the provincial drug regulatory department shall order them to rectify within a specified period of time; If the registrant and the entrusted production enterprise fail to take effective measures to eliminate the existing quality and safety risks, the provincial drug supervision and management department shall promptly take measures such as warning and responsibility interviews. If necessary, the registrant and the entrusted production enterprise may conduct joint responsibility interviews with the provincial drug supervision and management department where they are located.

If the registrant or entrusted production enterprise seriously violates the quality management standards for medical device production, and after comprehensive analysis and judgment, it is deemed that it affects product safety and effectiveness, and may endanger human health, the provincial drug supervision and management department may take emergency control measures to suspend production, operation, and use, and impose penalties strictly in accordance with Article 86 of the Regulations on the Supervision and Administration of Medical Devices.

The Announcement clearly states that the National Medical Products Administration will continue to promote the construction of medical device variety archives and credit archives, and promote the interconnection of information related to the commissioned production of registrants by standardizing the labeling of commissioned production information on registration certificates; Provincial Medical Products Administration should achieve full chain information connectivity in the supervision of medical devices within their administrative regions, collect information on evaluation and approval, registration quality management system verification, production permits, supervision and inspection, enterprise reports, supervision and sampling, and investigation of illegal activities, continuously update and improve the credit files of registrants and entrusted production enterprises, and push them to the national drug regulatory data sharing platform in accordance with the requirements of the National Medical Products Administration, gradually achieving cross provincial regulatory information exchange.

If cross regional entrusted production is involved, the provincial medical products administration where the registrant and entrusted production enterprise are located shall, in accordance with the requirements of the Measures for the Supervision and Management of Medical Device Production and the “Opinions on Strengthening the Collaborative Supervision of Cross regional Entrusted Production of Medical Devices, timely report the regulatory information of the enterprise’s production varieties, inspection results, and responsibility interviews.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：NMPA

Translated & edited： Bradyknow