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| Administration of implementation《Catalogue of medical devices》Relevant matters |
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| Author：中國銘鉉 企劃部 Release Time：2017-9-5 11:28:41 Number Browse：821 |
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Medical network - on September 5, to implement the regulations on the supervision and administration of medical devices and the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), the state food and drug supervision and administration bureau released on August 31, 2017, the catalog of medical device classification (hereinafter referred to as" new "catalog"), effective as of August 1, 2018. In order to implement the new catalogue catalogue, the relevant information circulars are hereby issued as follows:
1. The general description of the new classification catalogue
(a) the catalog of classification according to the new technology and clinical use characteristics are divided into 22 subdirectory, subdirectories by primary product categories, secondary product category, product description, intended use, commodity management category and examples. Determine the management of the product category, shall, according to the actual situation of products, combined with new product description in the catalog of classification, intended use and name, for example, a comprehensive judgement, the product description and the expected purpose is used to determine the management of the product category, does not represent the complete description of the related products registered trademark. Registered applicants can use the new catalog of the classification of goods, for example, or according to the medical equipment general name rules (the state food and drug supervision and administration of administration makes no. 19) to formulate the product name.
(2) the catalog of classification is not including in vitro diagnostic reagents, in vitro diagnostic reagents product category shall, in accordance with the "measures for the administration of registration of in vitro diagnostic reagent", (the state food and drug supervision and administration of administration makes no. 5, hereinafter referred to as the five order), the in vitro diagnostic reagents registration measures for the administration of amendment (administration makes no. 30, hereinafter referred to as 30 order), "6840 subdirectories in vitro diagnostic reagents classification (2013 edition) and the subsequent release of classification definition file in vitro diagnostic reagents to identify opinions, defines the classification of classification and coding it survives 6840.
(3) the new combination of the catalog of classification does not include the package products, composite products category shall be based on the medical device classification rules (the state food and drug supervision and administration of administration makes no. 15) and five words, 30 words make the judgment according to the relevant provisions.
(4) class I medical devices shall be released on the catalogue of notice "(the state food and drug supervision and administration bureau announcement no. 8, 2014), the food and drug supervision bureau staff about the implementation of class I medical devices for the record matters related to notice (food drug safety office machinery tube [2014] no. 174) and released after May 30, 2014 medical device classification definition file on the classification of class I medical devices products defined ideas continue to be valid. As of August 1, 2018, the product management category specified in the above documents is inconsistent with the new classification catalogue, subject to the product management category of the new classification catalogue.
(5) since August 1, 2018, in addition to the first (2) and (4) and the classification of always release definition file is not defined as the management of medical equipment product categories opinion, the original the catalog of medical device classification (the drug safety machinery [2002] no. 302, hereinafter referred to as the "catalog") and always release of medical device classification definition file contents and directory.
2. Related policies concerning registration and filing of medical devices
(6) for the first registration application which has been accepted and approved by August 1, 2018, the food and drug administration department shall, in accordance with the original classification catalogue, issue a registration certificate for medical devices.
For the first registration application which has been accepted but has not yet made the approval decision before 1 August 2018, the food and drug administration shall continue to review the contents of the classified catalogue. Of approving the registration, such as the new "classified catalogue does not involve product management category, according to a new medical device registration certificate issued by the" catalog "in the registration certificate in the remarks column indicate the original product classification and coding of the classified catalogue; Such as according to the new product the catalog of classification management category, continued in accordance with the original medical device registration certificate issued by the "catalog" and the registration certificate in the remarks column indicate the new product management category of the classification catalogue classification and coding (new classification of the catalog of classification coding for subdirectories number).
From August 1, 2018, the registered applicant shall apply for registration in accordance with the new classification catalogue.
(7) the application project which has been accepted and approved to continue registration by 1 August 2018 shall be approved by the food and drug administration according to the original classification catalogue.
The food and drug administration shall continue to review the application for the continuation of the registration application which has not yet been made for approval before 1 August 2018. Allow the continuation of register, such as according to the new "catalog" does not involve product management category, is in accordance with the new medical device registration certificate issued by the "catalog" in the registration certificate number in the remarks column indicate the original medical device registration certificate; Such as according to the new product the catalog of classification management category, continued in accordance with the original medical device registration certificate issued by the "catalog" and the registration certificate in the remarks column indicate the new product management category of the classification catalogue classification and coding.
Since August 1, 2018, the registrant shall, in accordance with the "measures for the administration of medical device registration" (the state food and drug supervision and administration of administration makes no. 4) and a new registration; continuation of the classified catalogue If the registration is continued, the food and drug administration shall, in accordance with the new classification catalogue, issue a registration certificate of medical devices and indicate the original medical device registration certificate in the remarks column of the registration certificate. Involved in product management category changed from high class to lower class, the registrant shall be 6 months before the expiration of the validity of the medical device registration certificate, to the corresponding according to change the category of the after the food and drug supervision and administration department to apply for the continuation of registration or handle for the record. The food and drug administration shall, in accordance with the new classification catalogue, issue the registration certificate of medical devices in accordance with the new classification catalogue; If the filing materials meet the requirements, make the filing vouchers; In addition, the registration card number of the original medical device is indicated in the change of registration certificate. If the category of product management is adjusted by the lower class to the higher category, the registrant shall apply to the corresponding food and drug administration department for registration according to the changed category. In the original validity term registration of medical device registration certificate, such as registration certificate expires during product category transformation work, put forward the original registrant may apply to the original examination and approval department medical device registration certificate delay the application shall be deferred and validity in principle, the original medical device registration certificate shall not be more than on August 31, 2019.
(8) for registration of change applications, the registration certificate of the medical device registration is the same as the original medical device registration certificate. If the original registration certificate is in accordance with the original, issued by the "catalog" issued by the registration after August 1st, 2018 change documents in the remarks column indicate the new at the same time the classification catalogue of product management category and classification and coding.
(9) the first category of medical device products that have been put on record before August 1, 2018, the original filing vouchers will continue to be valid. According to the new involving product category of the classification catalogue changed from low class to high class, for the record shall be according to the measures for the administration of the medical device registration (state food and drug supervision and administration of administration makes no. 4) and the new "catalog of classification regulation, according to the change of category applied to the food and drug supervision and administration department for registration, and complete registration on August 31, 2019.
Since August 1, 2018, shall, in accordance with the new the catalog of classification and class I medical devices shall be released on the catalogue of notice "(the state food and drug supervision and administration bureau announcement no. 8, 2014), the food and drug supervision bureau staff about the implementation of class I medical devices for the record matters related to notice (food drug safety office machinery tube [2014] no. 174) and 30 days in May 2014, of the medical device classification definition file issued implementation Suggestions about classification definition of class I medical devices products for the record.
(10) from November 1, 2017 to July 31, 2018, total bureau of national food and drug supervision and administration of medical devices standard management center of medical device classification defined application, respectively on the basis of the classification catalogue and new products are given in the catalogue of classification management category and classification and coding; From August 1, 2018, product management categories and classification codes will be given under the new classification catalogue.
3. Relevant policies for the production and operation of medical devices
(11) since August 1, 2018, held in accordance with the new medical device registration certificate issued by the application of the classified catalogue of medical equipment production license, food and drug supervision department shall be based on medical device registration certificate shall, in accordance with the new "catalog" fill in the medical device manufacturing license production scope and medical equipment product registration, which produce ranges should fill in the product category level.
Since August 1, 2018, under the new medical device registration certificate issued by the application of the classification catalogue changes to the medical device manufacturing license production scope or increase in the production of products, food and drug regulatory departments shall be based on medical device registration certificate to the medical device manufacturing license of the production scope and medical equipment product registration form is divided into the original classification and coding of the classified catalogue and new classifications in the catalogue of classification coding, and clearly identified, respectively indicate the scope of production and product information. Among them, according to the new classification catalogue, the production scope should be filled into the first-class product category. The production scope of the new and old versions shall not be mixed. After all products are registered and coded for the new version of the product, they shall not be partitioned.
(12) since August 1, 2018, issued by the new medical equipment business licenses and the second category of medical equipment business registration certificate of the scope of business should be divided into the original classification and coding of the classified catalogue and new classifications in the catalogue of classification coding, and clearly identified. The scope of business is filled into subcategories. The business scope of the new and old versions shall not be mixed, and all products shall be no longer partitioned after the registration certificate of the new version of the new product.
Provincial food and drug supervision and administration department shall, in accordance with the state food and drug supervision and management of the administration's unified deployment, the organization carries out the jurisdiction of new training work of the classified catalogue, supervise and guide the relevant units to implement the new "catalog". The food and drug administration at all levels shall timely study and deal with the problems encountered in the implementation of the new classification catalogue, and report to the department of food and drug supervision and administration in a timely manner.
Hereby notify.
Food and drug administration
August 31, 2017
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