August 2023 the Drug Administration issued a notice to adjust 58 items in the Medical Device Classification Catalog, covering a variety of aspects such as management category, product description, intended use and number of examples.
The new version of the Medical Device Classification Catalog is adjusted as follows:
Upgrading (4 items): 1 item of Class II medical device upgraded to Class III medical device (01-01-03 ultrasound surgical equipment under the accessory soft tissue ultrasonic cutter head class), 1 class of medical devices upgraded to 3 items of Class II medical devices, all of them 04 orthopaedic surgical instruments ( 04-14-06 positioning and guiding instruments under the additive manufacturing class, 04-16-03 positioning, guiding, measuring instruments under the additive manufacturing class, 04-16-08 positioning, guiding, measuring instruments under the additive manufacturing class)
Degradation (8 items): Class III medical devices downgraded to Class II medical devices 5 items (01-10-02 separation control box, 03-13-13 guide cannula, 03-13-16 guidewire, 04-17-01 vertebroplasty devices under the expansion of non-long-term implantation class, 09-07-03 microwave therapy equipment not for oncology class), Class II medical devices downgraded to Class I medical devices 3 (06-05-06 anti-scattering filter grids, 06-05-07 X-ray photography dark box, 22-15-03 automatic sampling system)
The latest version or adjusted version of the Medical Devices Classification Catalog can be accessed in the following two ways:
1. The State Drug Administration (NMPA)
China's main medical device and drug regulatory agencies, with authoritative and comprehensive information on national medical device regulations and announcements and notices.
Query method ①：
<进入官网>---定位<Medical Devices>，出现9尺寸数据库，点击 <法规文件>或<通告公告>，人工搜索医疗器械分类目录相关法规政策
Query method ②
<Enter the official website>--the upper right corner of the search box enter <Medical Device Classification Catalog>, the medical device catalog related policy documents, find the latest version, download the attachment to get the details of the Medical Device Classification Catalog.
But the Medical Device Classification Catalog released by the General Administration in the NMPA is not the final and latest version, you still need to find the table of the 4 partial content adjustments released by it and integrate it by yourself.
2. Query the latest medical device catalog through the Numerous Medical Devices Database (direct query)
Numerous Medical Devices is a vertical database for the medical device industry, which basically integrates all the dimensions of the whole industry chain of the medical device industry, including research and development, products, enterprises, markets, industry dynamics, policies and regulations, and other integrated database. Database.
Query mode ①:
Search <medical devices>--Enter the official website--Click <industry tools>under the <China medical equipment policies and regulations>, enter the number of Yu medical policy and regulations database, in the title of the database, the medical equipment policy and regulations. Medical device policies and regulations database, in the title box, enter <Medical Device Classified Catalog>, set up the screening conditions, such as the State Drug Administration and the local Drug Administration issued by a number of dimensions, retrieve the relevant documents, you can click on the <Data Source Address>, will jump to the official government issued documents page, click on the <Attachment list> under the < View More>, you can download the PDF version of the document, you can query the latest medical device catalog collection.
Query mode ②:
Search <Numerous Medical Devices>--Enter the official website--Click <Industry Tools>under <China Medical Devices Classified Directory>, do the condition Filtering, such as querying the latest medical device classification directory, management category can be selected Ⅰ, Ⅱ, Ⅲ, version number selection 2023, you can query the latest version of the medical device classification directory.
The search interface will show the primary classification, secondary classification, tertiary classification and product name examples, management category, device, version number and other columns, you can very quickly and intuitively understand the various types of medical device classification catalog information, but also through the field export text information.
The above v is about the new version of the medical device classification catalog adjustment content and query way to answer.