In order to implement the “Regulations for the Supervision and Administration of Medical Devices”, fully implement the quality and safety responsibility of medical device registrants (hereinafter referred to as registrants), further strengthen the supervision and management of the commissioned production, and effectively prevent and controll the risk of quality and safety of medical devices. The content of the announcement is summarized below:

1. Strict implementation of Registrant’s Main Responsibility

Registrants shall fully implement the main responsibility for the quality and safety of medical devices, the establishment of a quality management system covering the entire life cycle of medical devices and maintain effective operation.

2. Enhanced Management of Commissioned Production Registration

Registrants are required to obtain a credit information statement from the entrusted party and verify public information of the supervisory department to fully access the credit situation of the entrusted party before carrying out commissioned production.

3. Reinforced Supervision and Management of Commissioned Production

Registrants should establish and improve management organization which is appropriate with the commissioned production of product characteristics, enterprise scale. They should fully perform product risk management, change control, product release, after-sales service, product complaints, adverse event monitoring and product recall and other duties. Additionally, registrants should also regularly audit the operation of the quality management system of the entrusted production enterprise to ensure that it meets the requirements of relevant regulations and standards.

4. Special Requirements

For implantable medical devices, due to the impact on human health and safety, registrants are encouraged to prioritize in-house production. If it is necessary to entrust the production, registrants should send personnel with relevant experience in the field of production and quality management to be stationed in the entrusted production enterprise and provide on-site guidance and supervision on the key aspects of production management and quality management.

The announcement will come into effect on June 1, 2024. All companies involved in the commissioning of medical device registrants will need to rectify and standardize in accordance with the requirements of the announcement.

 

 

Reference:

50. NMPA Announcement on Further Strengthening the Supervision and Management of Entrusted Production by Registrants of Medical Devices (No. 38 of 2024)