The medical device catalogue is officially implemented, and the machinery enterprises will usher in major changes!

Medical Network August 3rd The CFDA released a new version of the "Medical Device Classification Catalogue" in the past nearly one year of buffer time, according to the previous public announcement: The new version of the "Medical Devices Classification Catalogue" will be officially implemented on August 1, 2018.

After the new version of the "Medical Device Classification Catalogue" was officially implemented, the medical device was given. enterprise The main changes brought about are the two main aspects of medical device registration and filing management, and medical device production and operation license:

1. From August 1, 2018, applicants for registration should apply for registration in accordance with the new Catalogue.

First registration application that has been accepted but not yet approved by August 1, 2018, food drug The supervisory and administrative department shall continue to review according to the original Catalogue of Classification; if the registration is granted, if it is not related to the product management category adjustment according to the new Catalogue, it shall be issued in accordance with the new Catalogue. medical instruments Registration certificate, indicate the original Classification Catalog product classification code in the remarks column of the registration certificate; if the product classification is adjusted according to the new Classification Catalogue, continue to issue the medical device registration certificate according to the original Catalogue and register The product category and classification code of the new Category Catalogue are indicated in the remarks column (the classification code of the new Catalogue is sub-directory number).

From August 1, 2018, applicants for registration should apply for registration in accordance with the new Catalogue.

2. From August 1, 2018, the registrant shall file an application for renewal registration in accordance with the Measures for the Administration of Medical Device Registration (Order No. 4 of the State Food and Drug Administration) and the new Catalogue.

For the continuation registration application that has been accepted before August 1, 2018 but has not yet made the approval decision, the food and drug supervision and administration department shall continue to review according to the original Catalogue; if the registration is granted, if the new Catalogue does not involve product management For category adjustment, the medical device registration certificate shall be issued according to the new Catalogue, and the original medical device registration certificate number shall be indicated in the remarks column of the registration certificate; if the product category management adjustment is carried out according to the new Classification Catalogue, continue to follow the original classification. The catalogue is issued with a medical device registration certificate, and the product category and classification code of the new Classification Catalogue are indicated in the remarks column of the registration certificate.

From August 1, 2018, the registrant shall file an application for renewal of registration in accordance with the Measures for the Administration of Registration of Medical Devices (Order No. 4 of the State Food and Drug Administration) and the new Catalogue of Classifications; The supervision and management department shall issue the medical device registration certificate in accordance with the new Classification Catalogue, and indicate the original medical device registration certificate number in the remarks column of the registration certificate. The product management category is adjusted from the high category to the low category, and the registrant shall be in the medical device. Before the expiration of the registration certificate, the applicant will apply to the corresponding food and drug supervision and administration department for renewal registration or filing according to the changed category.

If the food and drug supervision and administration department aligns with the continuation of registration, it shall issue a medical device registration certificate in accordance with the new Catalogue of Classification; if the filing materials meet the requirements, produce a record vouchers; and indicate the original medical care in the remarks of the registration certificate or the change of the registration vouchers. Device registration certificate number. If the product management category is adjusted from low category to high category, the registrant shall apply to the corresponding food and drug supervision and administration department for registration according to the changed category. If the application for registration is filed within the validity period of the original medical device registration certificate, When the registration certificate expires during the product category conversion work, the registrant may submit an application for extension of the original medical device registration certificate to the original examination and approval department for extension. In principle, the original medical device registration certificate shall not be valid until August 31, 2019.

3. For the registration change application, the registration number of the medical device registration change document is the same as the original medical device registration certificate. If the original registration certificate is issued according to the original Catalogue, the registration change document issued after August 1, 2018. The product management category and classification code of the new Catalogue are also indicated in the remarks column.

4. If the category is adjusted from a low category to a high category, the filer shall apply to the food and drug supervision and administration department for registration according to the changed category, and complete the registration before August 31, 2019.

The first type of medical device products that have been filed before August 1, 2018, the original filing certificate will continue to be valid. According to the new category, the product category is adjusted from low category to high category, and the filer should be based on the medical device registration management. The Measures (Regulation No. 4 of the State Food and Drug Administration) and the new Catalogue of Classifications apply to the Food and Drug Administration for registration in accordance with the changed categories, and registration is completed by August 31, 2019.

From August 1, 2018, the new Catalogue and the Notice on the Issuance of the Catalogue of Class I Medical Devices (National Food and Drug Administration Notice No. 8 of 2014), Food and Drug Administration Notice of the General Office on the Implementation of the Relevant Matters Concerning the Filing of the First Class of Medical Devices (Guide to Food and Drug Administration [2014] No. 174) and the medical device classification definition document issued after May 30, 2014 concerning the first category of medical device products Classification and definition of implementation of the record.

5. Since August 1, 2018, the product management category and classification code are given according to the new Catalogue.

From November 1, 2017 to July 31, 2018, the State Food and Drug Administration, medical equipment standard The management center's application for the classification of medical devices is based on the original Catalogue and the new Catalogue. The product management categories and classification codes are given respectively. Since August 1, 2018, the products are given according to the new Catalogue. Manage categories and classification codes.

1. Since August 1, 2018, with the medical device registration certificate issued in accordance with the new Catalogue, the food and drug supervision department shall fill out the medical treatment according to the new Catalogue of Medical Devices according to the medical device registration certificate. The production scope of the Equipment Production License and the registration form of the medical device production product, wherein the production scope should be filled out to the first-level product category.

Since August 1, 2018, if the medical device registration certificate issued in accordance with the new Catalogue of Changes is applied to change the production scope of the Medical Device Production License or increase the production of products, the food and drug supervision department shall, based on the medical device registration certificate, The production scope of the "Medical Device Production License" and the medical device production product registration form are divided into the original "Category Catalogue" classification coding area and the new "Category Catalogue" classification and coding area, and clearly marked, indicating the product production range and product information. Among them, the production scope filled in according to the new Catalogue of Classifications should be filled out to the first-level product category. The production scope of the new and old version of the classification code products shall not be mixed. After all the products are registered certificates of the new product classification code, they will not be partitioned.

2. From August 1st, 2018, the business scope of the newly issued medical device business license and the second type of medical device business record voucher shall be divided into the original "Category Catalogue" classification coding area and the new "Category Catalogue" classification coding area. And clearly identify the business scope to fill in the sub-category category. The old and new version of the classification code business scope can not be mixed, until all products are new version of the product classification code registration certificate, no longer partition.

All provincial food and drug supervision and administration departments shall, in accordance with the unified arrangements of the State Food and Drug Administration, organize the training of the new “Catalogue” in their respective jurisdictions, supervise and guide relevant units to implement the new “Catalogue”. Food and drug supervision and administration departments at all levels The problems encountered in the implementation of the new Catalogue shall be studied and handled in a timely manner, and reported to the food and drug supervision and administration department at a higher level in time.

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