New Regulation On The Supervision Of Medical Devices

On March 18, the full text of the new regulation on the supervision and administration of medical devices (hereinafter referred to as the "new regulation") was officially released. The new regulations will come into effect on June 1 this year. Compared with the current regulations on the supervision and administration of medical devices (2017 version), the new regulations make comprehensive provisions on encouraging innovation and development, quality supervision of life cycle, clinical evaluation of medical devices, conditional approval, emergency use, registration and filing, and punishment of legal liabilities to individuals.

The new regulations also put forward clear regulatory requirements for network sales of medical devices.

From the perspective of network sales operators, in addition to meeting the requirements of general medical device operation and management, operators also need to inform the competent food and Drug Administration of the relevant information about the network sales of medical devices they are engaged in (except for class II medical devices exempted from operation record). In addition, from the perspective of e-commerce platform, it should complete real name registration and qualification examination of online sales operators, and manage their business behaviors.

In addition, for public health emergencies, the new regulation also makes some provisions on emergency approval system.

Standardizing digital marketing of medical devices

In fact, in recent years, more and more medical enterprises try digital marketing, which brings great innovation to the traditional offline marketing mode. On the whole, different from the general industry, the medical industry (including medical devices) should still pay attention to the compliance risk in the process of online sales, considering the particularity of its products, the threshold of use and other factors.

A salesman of a medical enterprise in South China told the reporter of the 21st century economic report that the regulations for this industry were mainly based on the administrative measures for the supervision and administration of network sales of medical devices issued by the State Food and Drug Administration in December 2017. With the changes in the entire sales environment, the new regulations also add new contents to some specific implementation and supervision.

In the original provisions, the main body of online sales of medical devices is limited to two categories, one is the holder of medical device marketing license (i.e. the medical device registrant or the record holder), and the other is the medical device production and operation enterprises. Enterprises engaged in online sales of medical devices shall carry out online sales activities of medical devices through self built websites or third-party platforms for online trading services of medical devices.

The difference between the two sales models mainly lies in whether the operation registration subject selling Web / mobile applications belongs to a third-party enterprise that only provides network services and does not directly participate in the sales of medical devices. When judging the two sales modes, we should base on the operation registration subject of the web page / application that initiated the transaction last.

For example, although the medical device production and operation enterprises have their own websites, if the final sales are conducted through the links on the website and lead customers to other online shopping platforms, this mode does not belong to sales through self built websites; for example, the online sales of medical devices through wechat "applet" function seems to be through the third-party platform of wechat However, since the wechat applet does not provide the network page, but the network access service, the wechat platform is not the final page to initiate the transaction, so it can not be considered that the sales mode belongs to the third-party platform for medical device sales.

These two different sales models have different qualification requirements for the corresponding business entities.

For example, for operators who plan to build their own platforms or sell medical devices through third-party platforms, in addition to obtaining the administrative licensing procedures for medical device business, obtaining the Internet drug information service qualification certificate and other necessary qualifications, they also need to perform the necessary notification obligations to the competent FDA according to the new regulations.

And if the medical device business enterprises rely on the e-commerce platform, they also need to accept the supervision of the e-commerce platform. If promotion and sales are carried out through spokesperson, online Red live broadcast, etc., it may also constitute the release of medical device advertisement, which can be released only after the approval of medical device advertisement is obtained. This is because the State Administration of market supervision and administration clearly pointed out in the "guidance on strengthening the supervision of live network marketing activities" in November 2020, it is clearly pointed out that advertising of medical devices and other devices in the network live marketing activities should strictly abide by the relevant provisions of advertising review, and can not be released without review.

In fact, online sales of pharmaceutical equipment usually involves many subjects and links, such as drug equipment production, business enterprise / third-party platform, logistics distribution, etc. Among them, pharmaceutical equipment manufacturing / trading enterprises shall obtain corresponding licenses (the main body of direct C-end retail shall be drug retail chain enterprises); the business entities of network platform shall obtain the qualification of Internet drug information service, business license of value-added telecommunication business / Internet information service record, etc.; those entrusted with third-party logistics distribution shall meet the legal requirements and meet the quality standards 。

Improve the emergency approval mechanism for public health emergencies

Liu Mulong, executive partner of Xiantong capital, said in an interview with 21st century economic reporter that the regulation of medical device field has high technical requirements, which requires constant exploration and promotion from various parties to promote the healthy and orderly development of the whole industry.

The new regulation also specifies that for medical devices in clinical trial stage, in case of particularly serious public health emergencies or other emergencies that seriously threaten public health, the health authorities under the State Council shall put forward suggestions for the emergency use of medical devices according to the needs of prevention and control of incidents, which can be within a certain range and time limit after being demonstrated and approved by the drug regulatory department of the State Council Internal emergency use. In the regulations, due to the new crown epidemic situation, the use of equipment for emergencies and rare diseases is added; due to the test tube baby incident, a series of clinical requirements are added; according to the new development characteristics, the requirements for online sales are increased, and there are separate regulations for online sales; medical institutions can import less, and can make their own IVD for their own use.

In fact, after the outbreak of public health emergencies, many departments in China have made relevant attempts in emergency deployment management, import and export of medical products and emergency approval. For example, on the evening of January 26, 2020, the State Drug Administration launched the emergency approval process, and approved four kits from four companies in only four days to deal with the new coronapneumonia epidemic.

As three types of medical devices, the test kit can be officially put into the market after clinical trial and approval by the State Food and drug administration. It takes years for the test kit to enter the hospital for sale. The State Food and Drug Administration opened a green channel, greatly reducing the approval process, greatly helping and resolving the test anxiety of fighting the epidemic situation.

In addition, the heads of the Ministry of justice, the State Administration of market supervision and the State Food and drug administration also clearly pointed out that in order to meet the needs of responding to major public health emergencies and accelerate the use of urgently needed medical devices, the new regulations stipulate the following systems:

First, priority review and approval system. Give priority to the review and approval of innovative medical devices.

Second, conditional approval system. Medical devices that are urgently needed for the treatment of rare diseases, serious life-threatening diseases and for which there is no effective treatment means, and to cope with public health events, may be approved with conditions to speed up the marketing of the products.

Third, emergency use system. Referring to the vaccine management law, it is stipulated that medical devices can be used in a certain range and within a certain period of time in case of particularly serious public health emergencies or other emergencies that seriously threaten public health.

Fourth, special import system is urgently needed. It is stipulated that medical institutions that need to import a small amount of class II and class III medical devices urgently need to be imported with the approval of the drug regulatory department under the State Council or the people's governments of provinces, autonomous regions and municipalities directly under the central government authorized by the State Council.

Fifth, medical and health institutions to develop medical equipment system. It is stipulated that medical and health institutions may develop medical devices in response to public health emergencies, and the administrative measures shall be formulated by the drug regulatory department under the State Council in conjunction with the health department under the State Council.

In fact, there are many system innovation highlights in the supervision and management of medical devices in the new regulation, which well inherits the previous legislation and regulatory dynamics on drug supervision and management, so that the two major medical products, drugs and medical devices, can develop in a better way. At the same time, the new regulations also affirmed and established the first policy verified by local pilot at the national level, which laid a good foundation for further innovation and rapid development of medical devices nationwide.

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