The Food and Drug Administration announced that the new revision is exempt from the clinical trial medical device catalogue

In order to implement the General Office of the CPC Central Committee, the General Office of the State Council, “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in Drug Medical Devices” (Dongzi [2017] No. 42), the State Council deepened the reform requirements of 'distribution services' and further improved According to the Regulations on the Administration of Medical Device Registration and Management, the Measures for the Administration of Registration of In Vitro Diagnostic Reagents, the State Drug Administration has selected a new batch of medical devices that are exempt from clinical trials. In vitro diagnostic reagents) Table of Contents. In conjunction with the implementation of the newly revised Catalogue of Medical Devices, the organization has revised and summarized the three batches of medical devices (including in vitro diagnostic reagents) that have been released from clinical trials. The revised Catalogue of Medical Devices Exempted from Clinical Trials (Revised), Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Revised) will be published as of the date of promulgation.

Notice on the Issuance of the Second Category of Medical Devices Exempted from Clinical Trials (No. 12 of 2014), Notice on the Issuance of the Third Class of Medical Devices Catalogue Exempted from Clinical Trials (No. 13 of 2014) ), "Notice on the Release of the Second Batch of Medical Devices Exempted from Clinical Trials" (No. 133 of 2016), "Notice on Issuing the Third Batch of Medical Devices Exempted from Clinical Trials" (No. 170 of 2017) At the same time abolished.

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Free from clinical trials

Recently, the State Drug Administration issued a newly revised Catalogue of Medical Devices Exempted from Clinical Trials (hereinafter referred to as the New Exemption Catalogue), including 'medical device products' and 'in vitro diagnostic reagent products', respectively Covers 855 medical device products and 393 in vitro diagnostic reagent products.

I. About the products added in the new Exemption Catalogue

The new Exemption Catalogue added 84 medical devices based on the first three exemptions, including 63 medical devices, 21 medical devices, product names, classification codes, management categories and product descriptions. According to the newly released Catalogue of Medical Devices, the new Medical Device Classification Catalogue 02 Passive Surgical Instruments, 03 Neurological and Cardiovascular Surgical Instruments, 16 Ophthalmic Instruments, 18 Obstetrics and Gynecology, Assisted Reproductive and Contraceptive Subcategory The second category of products are listed in the new Exemption Catalogue in principle.

The new Exemption Catalogue adds 277 in vitro diagnostic reagents based on the first three exempted catalogues, including 246 in vitro diagnostic reagents and 31 in vitro diagnostic reagents. Product categories, product names, and product descriptions are based on In vitro diagnostic reagent classification sub-directory" (Food and Drug Administration [2013] No. 242) was prepared, the classification code was used 6840. For "About allergens, flow cytometry, immunohistochemistry and in situ hybridization in vitro diagnostics" The Notice of Reagent Product Attributes and Category Adjustments (No. 226 of 2017) is included in the new Exemption Catalogue as a general reagent for flow cytometry analysis managed by the second type of in vitro diagnostic reagents, and is noted in the remarks. In addition, according to the “Notice on the Basic Requirements for Clinical Evaluation of In Vitro Diagnostic Reagents for Clinical Trials (Trial) (No. 179, 2017), it is not applicable to cases where clinical trials are exempted, combined with product risks, in new The remarks in the Exemption Catalogue indicate that the intended use in the above catalogue is for patient self-test or neonatal testing related products, and is not a product category exempt from clinical trials.

Second, on the summary of the first three batches of exempted products in the new Exemption Catalogue

According to the product classification code, management category and product description in the “Medical Device Classification Catalogue” (hereinafter referred to as the “New Catalogue”) released in 2017, the State Food and Drug Administration organized and revised the first three batches of exempted catalogues that have been released. , to make it as consistent as possible with the new Catalogue for product identification. This revision regulates 536 product names and product descriptions of 1090 products in the first three batches of exempted catalogues, and has carried out 204 products. Integration or splitting, the management categories of 83 products were adjusted according to the new Catalogue, and the products that have been merged in the catalog and reduced to one category or no longer managed as medical devices were deleted.

Third, other notes on the new Exemption Catalogue

The product components listed in the product description of the new Exemption Catalogue, if they are managed separately in accordance with the medical device, and whose intended use is the same as the intended use in the product description of the new Exemption Catalogue, may be exempt from clinical trials.

For the second type of medical equipment products that are declared to be from the first type of medical equipment and not subject to clinical trials, they can be exempted from clinical trials without expanding the scope of application of the products.