New regulations for medical machinery will be revised and brought closer to law enforcement

Recently, the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)" has once again solicited opinions from the public and has caused widespread concern. In fact, the revision of the "Regulations on the Supervision and Administration of Medical Devices" was started as early as June 2006. On September 21, 2007, the public was solicited for revision; on December 19, 2008, the "medical device" was announced. The Regulations on Supervision and Management (Revised Drafts for Ratification) are again sought from various sectors. It has been four years since the start of the revision work in 2006. It has only solicited suggestions from all walks of life for three times, which shows that China attaches great importance to the Regulations on the Supervision and Administration of Medical Devices.

By reading the latest edition of the Regulations for the Supervision and Administration of Medical Devices (Revised Draft) (hereinafter referred to as the “Revised Draft”), it is found that the Regulations for Medical Device Supervision issued in 2000 are closer to the reality of device supervision.

New clause fills multiple blanks

The author believes that the most commendable point in the "Regulations for the Supervision and Administration of Medical Devices (Revised Draft)" is to fill many gaps in the 2000 edition of the Regulations, which will surely play a huge role in ensuring the safety and effectiveness of medical devices.

In the specification of medical devices, the revised draft establishes the following provisions: The content of medical device manuals, labels, and packaging labels must be in Chinese. What is even more valuable is that the revised draft sets penalties for substandard specifications. Although the "Regulations on the Administration of Medical Device Instruction Manuals, Labels, and Packaging Labels" stipulates that the content of manuals, labels, and packaging labels must be in Chinese, it does not specify in detail the contents that must be included, and no penalties have been established, which also makes the distribution channels unrecognized in Chinese. There are a large number of imported medical devices.

The revised draft stipulates that, when purchasing medical equipment, medical device operating companies and users should check the supplier's qualifications and the qualification certificates of the purchased equipment. They must establish and implement a purchase inspection and acceptance system, and make a good record of the purchase. , clear the items included in the purchase and sales records. At present, many units do not perform inspection and acceptance duties when purchasing medical devices. For this situation, the drug administration department has no legal basis for investigation. Due to the lack of inspection and acceptance, many unlicensed or counterfeit medical devices are sold and used.

The revised draft stipulates the medical device use system (Article 41): The medical device user must check, test, calibrate, maintain, and maintain the medical device in use, and record it. If it is found that there is a safety hazard, it must be stopped. The establishment of this clause can change the status of the use unit's misalignment or non-detection of new equipment.

Article 43 of the Regulations for the Supervision and Administration of Medical Devices (Revised Draft) regulates the transfer of medical devices for use between medical device users. At present, the transfer of medical devices is very common. However, due to the lack of legal restrictions, many medical devices without product registration certificates or even “disease” work enter the medical institutions through the transfer channel, causing hidden dangers in the use of machinery.

The revised draft provides detailed regulations for medical device advertisements and requires that products with serious illegal advertisements be sold. The establishment of this article means that the drug regulatory department has taken the initiative in the supervision of medical device advertisements and can take effective measures to ensure the order of medical devices.

Implementing the Physician Recall System

The revised draft stipulates that enterprises engaged in the wholesale business of medical devices and the third-line medical device retailers shall establish and implement a system of sales records, truthfully record the situation of wholesale medical devices and the retail sales of medical devices of the third category, and stipulate the content of sales records. And shelf life. The establishment of this provision laid the foundation for the traceability of medical devices.

The current laws and regulations do not require the traceability of medical devices. Only on March 18, 2003, the National Drug Regulatory Bureau and the Ministry of Health issued the “Notice on Continuing to Strengthen the Supervision and Administration of Medical Devices in Medical Institutions” (SFDA). City [2003] No. 118) was mentioned. However, the "Notice" is only a normative document and has no legal effect. The establishment of the above provisions will fundamentally change the execution of traceability.

In addition, Article 53 of the revised draft stipulates that the state establishes a recall system for medical device products and recalls defective medical devices. This system will help ensure the timely recall of defective devices when discovering medical device hidden dangers and eliminate potential safety hazards as soon as possible.

Other highlights

First, the penalties have been increased. The penalties established in the revised draft are more severe than the current “Regulations on the Supervision and Administration of Medical Devices”. If a person does not engage in the production of medical devices or operate Type II or Type III medical devices without authorization, the value of the goods will be less than 10,000 yuan. A fine of up to 50,000 yuan may be imposed, and a fine of 5 times or more and 10 times or less of the value of goods exceeding 10,000 yuan shall be imposed. Increased penalties can increase the deterrence of criminals.

Second, the provisions of the exemption clause. There is no exemption clause in the current laws and regulations related to medical devices, and there may be cases where the penalty is not equal. The establishment of the exemption clause in Article 75 of the revised draft fully embodies the people-oriented spirit and the principle of excessive penalty.

Third, the corresponding concept has been clarified. The definition of "medical device use unit" has been clarified. The use units include medical institutions that obtain the Medical Device Practice Permit and family planning technical service institutions, blood stations, apheresis plasma stations and non-medical institutions that do not require a permit according to law. Beauty agencies and so on. This definition includes the management of the previously unsupervised units that use medical devices.

Fourth, decentralized approval authority. The current laws and regulations stipulate that the second and third categories of “medical device operating enterprise licenses” shall be examined and approved by the Food and Drug Administration of the province, autonomous region, and municipality directly under the Central Government, and Article 36 of the revised draft stipulates that they shall engage in the business activities of the second and third categories of medical devices. , reviewed and approved by the local municipal bureau. This kind of regulation makes the examination and approval and supervision more closely integrated, and is more conducive to device supervision.

Fifth, the power operation is more transparent and open. Article 67 of the revised draft stipulates that the national food and drug regulatory authority shall formulate and adjust the catalogues stipulated in these Regulations and the specifications relating to the supervision and management of medical devices. They shall solicit public opinions; take hearings, demonstration meetings and other forms to listen to experts and medical devices. Opinions of production and management companies, medical device users, consumers, etc. This section regulates the operation of departmental authority to ensure that the operation of power is open, fair and transparent.

Needs to be improved

Of course, there are still several points worth discussing in the Regulations for the Supervision and Administration of Medical Devices (Revised Draft):

The revised draft stipulates that the state implements the record management of the first type of medical devices (Article 10). Filing is not an approval and there is not much coercive power. The author believes that although a type of medical device is safer, it is managed by medical devices after all. Its implementation standards, product specifications, and scope of adaptation are all subject to the approval of the supervisory department. For example, if the product is only for the record, There will be some hidden dangers, which may even lead to the confusion of one type of medical device, and the occurrence of “high class is low class” (such as the second class medical device is classified as a class of medical device). In addition, it will also lead to confusion in the scope of application of a class of medical device products. Therefore, the author proposes that the management of a type of medical device should still be managed in accordance with the current model, and production and sales should be based on the "certificate of medical device product registration."

The second paragraph of Article 28 of the revised draft stipulates 10 items that should be specified in the medical device product specification or label. The label is affixed to the device, easy to check and not easy to lose; the manual is not easy to lose and is not specific to a machine, there may be several models share a manual. Therefore, the label should contain at least the common name, model number, specifications, manufacturer's name, registered address, production address, production license number, registration certificate number, production date, etc. These contents must be written into the label to facilitate supervision.

Article 38 of the revised draft stipulates that "Medical device trading companies and users who buy medical devices should check the supplier's qualifications and the medical device's certificate of conformity." The author proposes that this article be stated as: "Medical device management Enterprises and users should purchase medical equipment from units that have qualifications for medical device operations, and check the supplier’s qualifications and certification documents for medical devices.”

Most of the current equipment transfer models are through equipment operators. First, equipment operators sell new equipment to medical institutions, and they purchase at a discount the replacement of the same old medical equipment. Then the operators sell the acquired equipment to other companies. Medical institutions. The draft does not have corresponding provisions in this regard and it is proposed to add corresponding clauses.

Article 69 of the revised draft stipulates that "If the value of a medical device that violates the law of production and operation is less than 10,000 yuan, a fine of up to 50,000 yuan shall be imposed." The author believes that such a provision makes the discretionary power so large that the value of the value of the goods is less than 1 The penalty of RMB 10,000 may be from RMB 0 to RMB 50,000. It is suggested that the discretionary authority should be reduced and flexibility should be reduced.

Article 1, paragraph 1 (1) of the revised draft stipulates that "the production, operation or import of medical devices that have not obtained the "Medical Device Registration Certificate" in accordance with the law", Article 72, paragraph 1 (d), " Medical equipment that has not been registered in accordance with the law, has not been registered in accordance with the law, or has no certification, or expired, expired, or eliminated medical equipment. In two cases, "the medical equipment that has not obtained the Medical Device Registration Certificate in accordance with the law" and "the business is not Registered in accordance with the law, the situation is slightly repetitive, the same situation appears in the two penalties, and the penalty range is different, it is recommended to amend.

In addition, Article 69, paragraph 1 (d), has the expression “exceeding the scope of medical devices approved by the “Medical Device Operation Permit” for operation of medical devices”, in which the expression “beyond the business scope” is not clearly stated. The "Measures for the Administration of Medical Device Operation Enterprise Licenses" stipulates two cases for "out of business scope." One of them is "enlarging the scope of business," referring to the sale of medical devices that exceed the operating right category; The type of device is not allowed on the license. The penalties for “enlarging business scope” and “beyond the scope of business” are different. The former imposes fines in addition to ordering corrections; the latter must first order corrections within a time limit, and impose fines if it is not overdue. Therefore, the author proposes to revise the relevant contents of the draft so that it is consistent with the relevant regulatory language.