Here is our summary :

1. Stricter Quality Management Requirements

As of today, NMPA together with the National Heath Commission and the National Healthcare Security Administration has published the lists of two batches of medical products that are subject to unique device identification system. The list includes all of the Class-III medical devices as well as all stock-in inspection record system for each product. Sales records of medical devices must include the name, model, specification, registration certificate number or filing number, quantity, unit price, and amount. If there is no validity period, they shall be kept for not less than 5 years. Article 41 of the Measures provides that medical device trading enterprises shall assist medical device registrants and filing entities to carry out adverse event monitoring.

2. Adjustment in Formalities for License or Record-Filing

• Exemption from record-filing for Class II medical devices whose product safety and effectiveness are not affected by distribution process; 
• The NMPA has already published a list of products that fall into this exemption category; 
• Re-registration of Class III Medical Devices Trading License; the applicant shall file a re-registration application between 90 working days and 30 working days prior to the expiration of the validity period of the license. 

3. Stricter Supervision Measures

Article 47 of the Measures provides that drug administrative authorities shall implement a classification and grading management system according to the quality management of medical device trading enterprises. The Measures also provide that if traded medical devices cause harm to human body or it is proven that it may endanger human health, they may suspend import, trading and use, and issue safety warning information.

4. Heavier Legal Liabilities

The Measures intensify the punishment on those acts specifically regulated under the Measures. If a medical device trading enterprise fails to submit its annual self-inspection report of the quality management system as required, or violates the provisions of these Measures, drug administrative authorities shall order corrections within a time limit. If harmful consequences are caused, a fine of not less than 100,000 RMB but not more than 200,00 RMB may be imposed.

Medical devices trading enterprises should follow the new requirements contained in the Measures to achieve full compliance. Drug administrative authorities at the city level (with districts) shall establish and update the credit files of medical device trading enterprises within their jurisdiction in a timely manner.

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