Supervision and management of medical device operations still need to be strengthened

Since the "Regulations on the Supervision and Administration of Medical Devices" was promulgated, especially after the "Measures for the Administration of Medical Device Operation Enterprise Licenses" and relevant implementation rules were formally implemented, under the effective supervision of the food and drug regulatory authorities, medical device manufacturers are gradually embarking on the standardization. Legal orbit. However, there is still a lot of problems in the management of medical device business licenses, such as the management methods and the quality of the devices. There are still many problems that need to be solved.

Operating methods and scope

At present, the licenses and business licenses for pharmaceuticals, foods, and other commodities are marked with the “business model” for wholesale or retail sales, and there is no “business model” for medical device licenses.

At present, there are two types of medical device management: wholesale, retail, and retail. Only the retail enterprise license has the words “The above business scope is retail” or “retail”. Those that are not reflected in the license are considered “wholesale” enterprises.

According to Article 29 of the Trial Implementation Regulations of the Anhui Medical Device Operational Enterprise License Management Regulation, “retail” is to directly purchase the purchased product to the consumer, which is generally the second type of medical device. Medical device products are mainly used by medical institutions, and only a small part can be used by consumers themselves. The author believes that changing the mode of operation of medical device licenses to "wholesale and retail" may be considered.

The “Measures for the Administration of Medical Device Operation Enterprise Licenses” has two provisions concerning the liability of medical device operators to expand their business scope without authorization: Article 35 stipulates that “Medical Device Operators shall expand their business scope and reduce operating conditions without authorization, from food and drug The supervision and management department shall order corrections within a time limit, make public criticisms, and impose a fine of more than 10,000 yuan but less than 20,000 yuan. The provisions of Article 38 stipulate that the medical device operating enterprise "exceeds the business scope set out in the "Medical Device Operation Enterprise License" to carry out operations. For activities, the food and drug supervision and administration department shall "order corrections within a time limit and give them a warning; if overdue, they shall be fined no less than 10,000 yuan but no more than 20,000 yuan." Obviously, this management approach only imposes economic penalties on the expansion of the scope of operations beyond the scope of operations, and does not provide for the treatment of the medical devices involved. The author believes that it is necessary to make targeted amendments.

Strict quality control

The current laws and regulations do not stipulate the qualifications and acceptance records required for the purchase and sale of medical device products. The author believes that drug purchasers must require that the purchased equipment must have a medical device manufacturing enterprise license or a medical device operating enterprise license or business license. Corporate procurement, and obtain a copy of the qualification certificate affixed with the official seal of the supplier, and establish the suppliers and product files of the purchased medical equipment."

Purchased medical devices shall meet the following basic conditions: medical devices produced and operated by legal enterprises; medical device registration certificates; product certifications; product quality standards; manuals, labels, and packaging labels shall comply with relevant regulations; The equipment must obtain legal bills and establish a true and complete medical equipment purchase record in accordance with regulations, so that the tickets, accounts, and goods are in compliance. Purchase records are saved as required.

In addition, penalties that do not implement the above issues should also be formulated to supervise and urge the operating companies to do this work well and strictly control the quality of medical devices.

The current medical device regulations do not stipulate whether the licensed operating companies should wholesale products to enterprises with legal qualifications. Because the relevant laws and regulations are not yet sound, coupled with the lack of regulatory power, the phenomena of unlicensed operations, overreaching operations, and the inability to open bills in the field of medical device circulation are still common. Therefore, legitimate medical device operators should be required to sell medical device products to enterprises with legal qualifications to prevent the circulation of counterfeit medical devices.

Avoiding blind spots when opening up operations

In May 2005, the State Food and Drug Administration announced the first batch of the second category of medical device product catalogs that do not require the application for a “Medical Device Operation Enterprise License”, a total of 7 categories and 13 products. The second paragraph of Article 24 of the "Regulations on the Supervision and Management of Medical Devices" promulgated by the State Council clearly stipulates that the establishment of second- and third-class medical device operating enterprises shall be subject to the examination and approval of the drug regulatory agencies of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government, and shall be issued to "Medical Device Operation Enterprise License." Without the "Medical Device Operation Enterprise License", the administrative department for industry and commerce shall not issue a business license.

At present, in accordance with the relevant provisions of the “Measures for the Administration of Medical Device Operation Enterprise Licenses”, some of the business activities of the second category of medical device products have been liberalized. Some local administrative departments for industry and commerce, in accordance with the "Regulations on the Supervision and Administration of Medical Devices," still require that some of the medical device products that are released should still be subject to the Medical Device Operation Enterprise License. The author proposes that the second category of medical device product management companies should apply for the “Medical Device Operation Enterprise License”, and a few of the second type of medical device products that can ensure safety and effectiveness through routine management in the circulation process can pass medical devices. Product catalogs are adjusted.

The current "Regulations on the Supervision and Management of Medical Devices" stipulates that the establishment of the first category of medical device operating enterprises shall be filed with the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. However, after the issuance of the "Administrative Permit", the State Council cancelled the administrative record filing system, and now the first type of medical device operating enterprise no longer needs to go to the drug regulatory department for the record, and the drug regulatory department is responsible for the first type of medical device operating enterprise within its jurisdiction. The basic situation of quantity, company name, business address, legal representative, and contact information is not comprehensive enough, which will lead to the first category of medical device operating companies and products becoming blind spots in the circulation area.

The author proposes to adjust the current classification criteria and specify the specific responsibilities of the supervisory department.

Supplementary license changes

The “Registration Matters” in Article 17 of the “Measures for the Administration of Medical Device Operation Enterprise Licenses” of the “Medical Device Operation Enterprise License” do not include the legal representative and the responsible person of the enterprise. This is incompatible with the approval of the administrative department for industry and commerce. The author suggests that the legal representative and the person in charge of the company should be listed as a license. As the business unit’s share rights, claims, etc. also need to be changed, this requires that the legal representative who has been changed and the person in charge of the company must agree. Therefore, in the application materials for the change of the legal representative and the responsible person, the consent change statement signed by the legal representative and the person in charge of the company shall be added.

In addition, Sections 33, 34, and 35 of the “Measures for the Administration of Medical Device Operational Enterprise Licenses” stipulate the specific penalties for unauthorized change of the person in charge of quality, registered address, warehouse address, expansion of business scope, and reduction of operating conditions without unauthorized change. Penalties for company name, legal representative, and person in charge of the company. The author proposes to add “The medical device operating enterprise fails to go through the formalities for the change of the “Medical Device Operation Enterprise License” as required, and the food and drug supervision authority shall order it to make corrections within a time limit. Any overdue refusal to make corrections shall be fined from 5,000 yuan to 10,000 yuan.”

In response to the above problems, the relevant state departments should speed up the legislative work of medical device supervision. Prior to this, the provincial food and drug administration should explain and refine the relevant provisions of the supervision and management of medical devices in the form of regulatory documents. At the same time, local governments should also actively participate in the legislative work of medical device supervision and management.