Anhui Printing and Distributing the New Regulations for the Recording Management of the First Class of Medical Device Products

Recently, the Anhui Food and Drug Administration issued the “Administrative Measures for the Recording of the First Class of Medical Device Products in Anhui Province” (hereinafter referred to as the “Measures”) to strengthen the management of the first category of medical devices and control product safety risks.

Due to the easy access to records and the reduced frequency of supervision, some of the non-standard and illegal first-class medical devices are listed in a more relaxed management environment. In 2016 alone, the Anhui Provincial Bureau found 19 kinds of products, such as urine collectors, medical infusion stickers, and medical cotton swabs, in the retrospective review of medical device filing information. There are non-medical devices as medical devices for record, high class and low stroke. , product name and intended use are not standardized, a multi-word and other issues. To this end, the Anhui Provincial Bureau issued this "Measures", clarifying the duties of the regulatory authorities and the main responsibility of the filer, and making detailed provisions on the changes in the filing matters, information management and publicity, and after-the-fact supervision.

The method is clear and has not been included in the catalogue or the medical equipment that is not clearly defined by the State Food and Drug Administration. The filer can judge the product category according to the classification rules and apply to the State Administration for category confirmation through the classification definition system, which is confirmed as the first category of medical treatment. Only the equipment can be used for product filing.

The method also specifies the changes in the filing matters. For the change of product name, product description, and intended use, the changed content shall be consistent with the corresponding contents of the first category of medical device catalogue and the corresponding in vitro diagnostic reagent sub-directory. Among them, according to the category, the product names listed in the “product name example” in the catalogue are used preferentially. If not, the product name should be standardized with reference to the medical device naming principle; the product description and intended use should be the same as or not listed in the catalogue. Exceeded the contents of the directory.

The measures require that the first type of medical device filing, change filing and cancellation of records are all included in the management of the "Medical Device Registration Management Information System Filing Subsystem", and the Municipal Food and Drug Administration is required to determine the management and maintenance of the registration management information system. Within 3 months from the date of filing of the first type of medical device products, the municipal bureau of the district must also conduct on-site verification of the enterprise in accordance with the requirements of the “Quality Management Regulations for Medical Device Production”. Verify the authenticity of the product filing materials, whether to organize production according to the technical requirements of the registered products, and whether the quality management system of the enterprise maintains effective operation.

The Anhui Provincial Bureau stresses that the Municipal Food and Drug Administration of the district shall not illegally release the records of the first type of medical devices, and shall not carry out the filing of the first type of medical devices in violation of regulations. It is strictly forbidden to implement high-class low-level planning and non-medical devices as medical devices. And other behaviors. Anyone who provides false information at the time of filing shall be notified to the public about the filing unit and product name according to law; if the circumstances are serious, the directly responsible personnel shall not engage in medical device production and management activities within 5 years.

Notice of the Anhui Food and Drug Administration on Printing and Distributing the Administrative Measures for the Recording of the First Class of Medical Device Products in Anhui Province

皖食药监器秘 [2016]713

Municipal and Zhiguan County Food and Drug Administration:

In order to strengthen the supervision and management of medical devices and standardize the filing of the first type of medical device products, the provincial bureau has formulated the "Administrative Measures for the Recording of the First Class of Medical Device Products in Anhui Province", which is now issued to you, please follow the implementation.

Anhui Food and Drug Administration

December 29, 2016

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