China’s IVD reagent classification catalogue has been revised and reissued for industry comment. The National Medical Products Administration (NMPA) has recently revised the “Regulations for the Supervision and Administration of Medical Devices”, “In Vitro Diagnostic Reagent Registration and Filing Management”, and “In Vitro Diagnostic Reagent Classification Rules”. As part of this revision, a new in vitro diagnostic reagent classification catalogue has been developed and is now open for comments.
If you are a manufacturer in the in vitro diagnostic reagent industry, this is a crucial opportunity for you to have your say on the revised draft for solicitation of comments. By providing your feedback, you can help shape the final version of the classification catalogue, which will provide the basis for in vitro diagnostic reagent classification risk management requirements in China.
The current catalogue dates from 2013 with adjustments made for a small number of products in 2020 (see below). The proposed changes to the catalogue in 2023 will impact the structure of the catalogue and how products are classified.
The new structure of the catalogue will include five categories: serial number, primary product category, secondary product category, intended use, and management category. The primary product category will be established based on the “Classification Rules,” which includes 25 categories. The secondary product category will further refine the primary product category, based on detection targets, without including methods or principles. In total, there will be 2046 secondary product categories.
The intended use category will include information about the tested substance and the main clinical use of the product. This information will be used to determine the management category of the product, but it does not represent a complete description of the registered content of the relevant product.
If the product’s intended use involves human samples, the sample should be clearly stated as cerebrospinal fluid, urine, gastric juice, or another corresponding sample. If the product is used for testing multiple samples, it should be expressed as “used for testing human samples.”
These changes in the catalogue’s structure and product classification will provide more detailed information for regulatory professionals to understand the products and their intended use. It will also help to better regulate these products and ensure their safety and efficacy in the market.
To participate, simply fill out the feedback form and send it to mdct@nmpa.gov.cn with “In vitro diagnostic reagent classification directory” indicated in the subject of the email. The deadline for submission is April 12, 2023.
Further information
Click here to access the 2013 IVD Reagent Classification Catalogue.
Click here to access the 2020 update to the 2023 catalogue.
Read our previous article on the 2020 update.
Click here to access the 2023 proposal.
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