On June 1, the newly revised “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “New Regulations”) were officially implemented. Registrants will bear corresponding legal responsibilities for the product quality of the entire life cycle of medical devices. Industry understanding summarizes this as “lenient access, strict management, and heavy penalties.” On the afternoon of May 31, the State Food and Drug Administration issued an announcement on matters related to the implementation of the new “Regulations”, stipulating that starting from June 1, 2021, all enterprises and medical device research and development institutions that hold a medical device registration certificate or have gone through the filing of Class I medical devices must perform the obligations of medical device registrants and filers respectively in accordance with the provisions of the new “Regulations”, strengthen the quality management of the entire life cycle of medical devices, and bear responsibility for the safety and effectiveness of medical devices throughout the entire process of development, production, operation, and use.
Establish the registrant system as the core system for medical device supervision
Those who meet the regulations are exempt from clinical evaluation
Step by step implementation of the unique identification system for medical devices, products will have “ID cards”
In addition, the new “Regulations” propose that the state will implement a unique identification system for medical devices step by step according to the category of medical device products to achieve traceability of medical devices. According to the relevant person in charge of the Liaoning Provincial Food and Drug Administration, the unique identification of medical devices is the “ID card” of medical device products and the “international language” of medical devices. As a common international practice, countries and regions such as Europe and the United States are actively promoting this system. The medical device unique identification system consists of a medical device unique identification, a data carrier and a database. Each medical device is given an ID card to achieve transparency and visualization in all aspects of production, operation and use, and improve product traceability. Establishing a unique identification system can strengthen the supervision of the entire life cycle of medical devices, and can also build big data for medical device supervision, so that the sources of medical devices can be traced, their whereabouts can be traced, and responsibilities can be held accountable, and smart supervision can be realized.
Encourage innovation and prioritize review and approval of innovative medical devices
In addition, regarding the investigation and punishment of medical device violations, the State Food and Drug Administration emphasized that if medical device violations occurred before June 1, 2021, the pre-revised “Regulations” shall apply. However, if it is deemed not illegal or the penalty is lighter according to the new “Regulations”, the new “Regulations” will apply.