CFDA expressly refuses to recall penalties for defective medical products

According to the website of the Food and Drug Administration, the website of the Food and Drug Administration announced today the “Administrative Measures for Medical Device Recall”. The "Measures" stipulate that medical device manufacturers refuse to recall medical devices, and the circumstances will be ordered to suspend production and business.

On June 1, 2014, the newly revised Regulations on the Supervision and Administration of Medical Devices was promulgated and implemented, and new requirements for medical device recalls were proposed. The State Food and Drug Administration has organized the revision of the original "Administrative Measures for Medical Device Recall (Trial)" to form the "Administrative Measures for Medical Device Recall", which will take effect on May 1, 2017.

The medical device products that are described as defective in the Measures include:

(1) Products with unreasonable risks that may endanger human health and life safety under normal use;

(2) Products that do not meet the technical requirements of the mandatory standards, registered or filed products;

(3) Products that do not meet the relevant regulations on the production and operation quality management of medical devices, which may lead to unreasonable risks;

(4) Other products that need to be recalled.

According to the Measures, according to the different starting conditions of medical device recalls, medical device recalls are divided into active recalls and ordered recalls.

CFDA明确拒绝召回缺陷医疗产品处罚标准

Data map. Shooting

According to the severity of medical device defects, medical device recalls are divided into:

(1) Level 1 recall: the use of the medical device may or may have caused serious health hazards;

(2) Secondary recall: the use of the medical device may or may have caused temporary or reversible health hazards;

(3) Three-level recall: The use of the medical device is less likely to cause harm but still needs to be recalled.

Food flavoring


China Food flavoring Suppliers

Here you can find the related products in Food flavoring, we are professional manufacturer of Food flavoring Raw Material. We focused on international export product development, production and sales. We have improved quality control processes of Food flavoring to ensure each export qualified product.

If you want to know more about the products in Food flavoring, please click the Product details to view specification, application, pictures, prices and Other information about Food flavoring.

Whatever you are a group or individual, we will do our best to provide you with accurate and comprehensive message about Food flavoring!




Tartaric Acid, Vanillin, Menthol, Menthol Crystal, Flavoring agent, Baking powder

Xi'an Gawen Biotechnology Co., Ltd , https://www.ahualyn-bio.com