<

Food and Drug Administration issued a "medical device recall management approach"

 

  June 1, 2014, the newly revised "medical device supervision and management regulations" promulgated and implemented, put forward new requirements for medical device recall. The State Administration of Food and Drug Administration organized the original "medical device recall management approach (Trial)" was modified to form a "medical device recall management approach" (hereinafter referred to as "measures"), January 5, 2017, "approach" by State Administration of Food and Drug Administration Bureau of the Council considered and adopted, since May 1, 2017 from the implementation.

  The main changes involved in the following: First, the implementation of medical equipment to recall the responsibility of the main body. Clarification of the domestic medical device product registrant or filing person, the foreign manufacturer of imported medical equipment designated in China is the agent responsible for the implementation of medical equipment recall. Second, there is a clear defective range of medical devices. In accordance with Article 52 of the Regulations on the Supervision and Administration of Medical Devices, "medical device manufacturers that have found their medical devices that do not meet the mandatory standards, registered or filed product technical requirements or other defects, should take the initiative to recall the listed products (C) products that are: (a) products that are at risk of unreasonable risks that may endanger human health and safety in normal use; (b) fail to comply with a mandatory standard, (3) products that do not meet the requirements of medical equipment production and operation quality management, which may lead to unreasonable risks; (4) other products that need to be recalled. Third, strengthen the medical equipment recall information disclosure requirements. Detailed medical equipment manufacturing enterprises to implement the recall of information dissemination obligations, the provisions of the implementation of a recall, medical equipment recall notice should be published in the State Food and Drug Administration website and the central media; the implementation of two, three recall, medical The recall notice shall be published on the website of the provincial food and drug supervision and administration department, and the recall notice issued by the provincial food and drug supervision and administration department website should be linked with the website of the State Food and Drug Administration. Food and drug regulatory authorities decided to order the recall, by the decision of the food and drug supervision and management departments in its website to the community announced the order to recall information, and asked the medical device manufacturers to the company to announce the product recall information. Fourth, to further strengthen the supervision of food and drug regulatory responsibilities. Clearly in addition to the medical device manufacturing enterprises located at the provincial food and drug supervision and management departments, the approval of the medical device registration or filing for food and drug supervision and management departments may also make a decision to recall the order. At the same time, refinement of food and drug supervision and management departments and their staff do not perform their duties or abuse of power, and the provisions of the corresponding penalties.

  In addition, the "approach" also made it clear that the medical device manufacturers should establish a sound medical device recall management system, strengthen the medical equipment manufacturing enterprises to recall the reporting obligations, improve the food and drug supervision and management departments of the communication requirements.
 
【Disclaimer】

This article is reproduced, only for communication, does not represent the views of this site, Ben Wang is not responsible for the authenticity of the content, hereby declare. If the content, copyright and other issues involved, please contact the site within 30 days, we will be the first time to remove or replace the relevant content, but not related to compensation commitments. The copyright of this article and the content of the interpretation of the original author.