Released by the NMPA! New quality management standards have been released, and medical equipment supervision has been upgraded
On September 18, the General Division of NMPA publicly solicited the opinions of the Medical Device Network Sales Quality Management Specification (Draft for Comment) and attached the Medical Device Network Sales Quality Management Specification (Draft for Comment) (hereinafter referred to as the Draft for Comment) and the Comments and Suggestions Feedback Form Template.
In order to strengthen the quality management of the medical device network sales link, ensure the quality and safety of medical devices, and promote the healthy, orderly and high-quality development of the industry, NMPA publicly solicited the opinions of the Medical Device Network Sales Quality Management Specifications (Draft for comment) on September 18, 2023.
【Background analysis】
It is estimated that in 2022 alone, the online sales of drugs and medical devices have reached 292.4 billion yuan, and it is expected to exceed 350 billion yuan in 2023. This rapid growth trend has also made the quality management of medical device network sales the focus of attention.
【key point】
The newly released Quality Management Specification for Online Sales of Medical Devices (Draft for Soliciting Opinions) includes four chapters and a total of 74 regulations, aiming to standardize the quality management of online sales from the perspectives of online sales operators and platform operators. According to each chapter, the Specification proposes the following key points:
# General Rules
The general provisions make clear the purpose basis, scope of application, summary requirements and other contents of this specification. The key points are as follows:
1.Encouraging innovation: Article 6 clearly encourages the use of new technologies such as big data, cloud computing, and artificial intelligence to implement quality control to improve the quality management level of medical device network sales.
- Electronic management: Encouraging the use of electronic technology to transfer and store electronic license information issued by relevant government departments to improve the accuracy and traceability of information.
- Unique identification management: It is proposed that operators should actively use the unique identification of medical devices for quality management to achieve the traceability of medical devices.
# Quality Management of Network Sales operators Chapter 2 “Quality management of network sales operators” is divided into four sections: system and responsibilities, personnel and training, facilities and equipment, and quality control of network sales process, with a total of 32 contents. Among them, Article 14 is similar to the laboratory audit trail, emphasizing “to ensure that the medical device network sales data and records are true, accurate, complete and traceable, and shall not arbitrarily tamper with the data.” And relevant records should be kept as required.
The second section, Personnel and training, respectively, makes requirements for the front, middle and back-end personnel of online sales of in vitro diagnostic reagents, testing equipment personnel, live broadcast marketing personnel and after-sales technical service personnel.
In addition, Section 4 “Quality control of online sales process” makes requirements for retail variety review, product information display requirements, outbound review and other work, and specifies the content that should be included in online sales records.`
# Platform operator quality management Chapter 3 “Platform Operator Quality Management” also includes three sections: system and responsibilities, personnel and training, facilities and equipment, in addition to the quality control of online transaction service process. Among them, Article 44, 45, and 46 respectively specify requirements for platform operators’ data record management, data record management and preservation, and live broadcast data record management and preservation. This also reflects the importance that medical device network sales attach to data recording.
In addition, this chapter also makes requirements for the admission of online sales operators and the admission of online sales of medical devices.
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Source：Medical Device Market
Translated & edited ： Bradyknow
