Medical device operators, the new rules come into force in July

2024-07-11

On 1 July 2024, the revised Code of Practice for the Quality Management of Medical Device Businesses (“the Code”) by the NMPA has came into force. The former State Food and Drug Administration’s Announcement on the Enforcement of the Code of Practice for the Quality Management of Medical Device Operations (No. 58 of 2014) is repealed at the same time.

What are the changes in the new Code? What do medical device operators need to pay attention to? For your better understanding, some of the key contents are extracted below:

New chapters of the Code

Chapter II of the Code, Establishment and Improvement of Quality Management System is a new chapter with 5 articles, including the establishment of quality system, quality policy and objectives, fulfilment of the main responsibility, system self-examination, and continuous improvement of the content of the articles.

Main elements of the revision of the Code

Appropriate revisions have been made to the provisions of the 2014 version of the Code that have difficulties in implementation and misunderstandings in enterprise management and regulatory practices, in order to make the content of the regulations more in line with the actual situation of quality management and supervision in the medical device operation process.
New regulatory elements have been identified and supplemented to adapt to the new regulatory approach. The requirements for the unique identification of medical devices in product acceptance, outbound review, and computer systems have been clarified. Electronic certificates and paper certificates have the same legal effect, and enterprises are encouraged to use information technology to transmit and store electronic certificate materials.
New forms of business and new ways of operation have been identified in order to supplement the blind spots of quality management in the business process. For example, quality management of automatic device machines, management of multi-warehouse collaboration, and management of products sold after clinical confirmation have been added.

(1) Setting and management of automatic device selling machine

Setting up automatic device selling machines in the sales process of medical devices can improve and speed up the accessibility of medical devices. While improving the accessibility of medical devices, relevant quality management needs to be strengthened. The Code have clarified that automatic device selling machine is an extension of the retail business premises for medical devices, and put forward specific requirements for the operating entity, number of settings, functions, internal display environment, establishment of after-sales mechanism, storage and shipment, regular inspection, and issuance of sales vouchers of automatic device selling machine, to ensure that the operation process of automatic device selling machine operates in a quality controlled state, and to ensure the quality and safety of medical device products and business processes.

(2) Setting up and management of multi-warehouse collaboration

With the rapid development of China’s logistics industry, combined with the issued and implemented Notice of the National Medical Products Administration on the Handling of Cross administrative Region Warehouse Setting for Medical Device Operating Enterprises and “Appendix to the Quality Management Standards for Medical Device Operating Enterprises: Quality Management for Enterprises Specialized in Providing Medical Device Transportation and Storage Services, the Code have added provisions for multi warehouse collaboration, clearly stipulating that enterprises can establish warehouses across administrative regions, entrust enterprises specialized in providing medical device transportation and storage services across administrative regions, etc., to build a national or regional multi warehouse collaborative logistics management model. Enterprises should strengthen quality management for warehouses set up across administrative regions, and equip them with computer information systems that are interconnected with the operating enterprise headquarters and capable of real-time interaction of medical device storage and inbound and outbound data.

New requirements for storing medical devices in the warehouse

Enterprises should store medical devices reasonably based on their quality characteristics. According to the actual situation of medical device products, the “Specification” has revised and refined the management of in warehouse storage. For example, when storing in a cold storage, a reasonable storage area should be determined based on the cold storage verification report, and the air outlet of the refrigeration unit should avoid obstruction. When handling, stacking, and placing medical devices, they should be operated in accordance with the packaging labeling requirements. The stacking height, placement direction, etc. should comply with the packaging diagram requirements, and should be stored properly according to the load-bearing range of shelves and pallets to avoid damage to medical devices. Medical devices and non-medical devices sold in combination may not be stored separately; In automated warehouses that implement automated operations, medical devices and non-medical devices can be stored separately by location. When storing products in the warehouse that include non-medical devices, it is necessary to manage the warehouse zoning, fully assess the pollution risks of non-medical device products to the storage environment and personnel, and develop measures to ensure the safety of the medical device storage environment

ThThe contents that should be included in the accompanying bill of lading lading

According to the Code, enterprises engaged in wholesale business of medical devices shall attach a accompanying bill of lading and affix the outbound seal of the enterprise or the commissioned specialized medical device transportation and storage service enterprise when medical devices are shipped out. The accompanying bill of lading should include: the name of the supplying enterprise, the name of the medical device registrant, filer, and entrusted production enterprise, the name, model, specifications, registration certificate number or filing number of the medical device, the production batch number or serial number, expiration date or expiration date, quantity of the medical device, transportation and storage conditions of the medical device, the name of the enterprise specializing in medical device transportation and storage services (if any), the name of the receiving unit, delivery address, contact information, delivery date, etc.

Record content of transportation process

The Code have specified the content that should be recorded during the transportation of medical devices. Enterprises should transport medical devices in accordance with relevant regulations and transportation operation procedures, choose reasonable transportation vehicles and routes, ensure product protection during transportation, ensure the quality and safety of medical device products during transportation, and keep transportation records. The transportation record should include: the name, address, contact information, transportation method of the receiving unit, the name, model, specifications, registration certificate number or filing number of the medical device, production batch number or serial number, unit, quantity, delivery date, and other contents. When entrusting transportation, the name of the carrier and the waybill number should also be recorded. When self transporting, the license plate number of the transport vehicle and the transport personnel should be recorded.

After sales service requirements

The Code stipulates that enterprises shall provide corresponding after-sales services in accordance with the quality responsibilities and after-sales service responsibilities agreed upon with the supplier in the procurement contract or agreement, as well as the quality responsibilities and after-sales service responsibilities agreed upon with the purchaser. If enterprises use third-party organizations to provide after-sales service support, they should choose service organizations with quality assurance capabilities, sign a written quality assurance agreement, stipulate the quality responsibilities and obligations of both parties, and clarify the scope of after-sales service and quality management requirements.

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Source：Xieshitong

Translated & edited： Bradyknow