The newly revised "Medical Device Management Quality Management Standard" will be implemented on July 1, and these changes need attention.

Release time:

2024-06-14 15:39

Announcement No. 153 of the State Drug Administration on December 4, 2023, "Medical Device Business Quality Management Regulations" will come into force on July 1, 2024. The Announcement of the former State Food and Drug Administration on the Implementation of Medical Device Business Quality Management Standards (No. 58 of 2014) shall be abolished at the same time.

Compared with the 2014 edition, the new edition of "Medical Device Management Quality Management Standard" has a total of 10 chapters and 116 articles, including general principles, establishment and improvement of quality management system, responsibilities and systems, personnel and training, facilities and equipment, procurement, receipt and acceptance, warehousing, storage and inspection, sales, outbound and transportation, after-sales service, and supplementary provisions.

These points of change in the new revision need to be focused on.

1. Clarify the scope of application: the newly revised quality specifications not only need to be implemented by medical device business enterprises, but also relevant requirements should be implemented by medical device registrants and filers selling their registered or filed medical device products, as well as the storage and transportation links involved in the circulation of medical devices.

2. Strengthen the quality management system: the new specification adds a chapter on the establishment and improvement of the quality management system, requiring enterprises to establish and improve the quality management system in line with the requirements of the specification, including quality management system documents, organizations, personnel, facilities and equipment.

3. Requirements for quality records and traceability of medical devices: the new specification specifies the requirements for the unique identification of medical devices in terms of product acceptance, outbound review and computer system, and emphasizes the requirements for the retention period of quality records. incoming inspection records and sales records shall be kept until 2 years after the expiration of the validity period of medical devices. If there is no validity period, it shall not be less than 5 years. Implantable medical devices purchase inspection records and sales records shall be kept permanently.

4. Multi-warehouse collaborative business model: The new standard specifies that enterprises can build a national or regional multi-warehouse collaborative logistics management model by setting up warehouses across administrative regions or entrusting enterprises specializing in providing medical device transportation and storage services. Enterprises should strengthen quality management of warehouses set up across administrative regions, and be equipped with computer information systems that are interconnected with the headquarters of operating enterprises and can interact with medical device storage and incoming and outgoing data in real time.

5. Management requirements for new sales formats: specific requirements are put forward for new business models such as the operating entity, setting location, setting quantity, functions of automatic selling machines, internal display environment, establishment of after-sales mechanism, storage and shipment, regular inspection, issuance of sales credentials, etc. At the same time, the quality management of direct transfer operation and the management of sales products after clinical confirmation are clearly defined.

Cancellation of GMP certification means stricter supervision of drug production?

Customs clearance tips for imported pharmaceutical excipients

Cancellation of GMP certification means stricter supervision of drug production?

Customs clearance tips for imported pharmaceutical excipients

Latest developments

Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo

Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official

Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you

Cancellation of GMP certification means stricter supervision of drug production?

The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.

Dry goods! Common technical questions and answers on new raw materials for cosmetics