On October 31, 2022, China’s NMPA published an updated Classification Catalogue for public comment. The public has until November 24th to provide feedback before the NMPA finalizes the changes. A total of 57 items are expected to be adjusted, including 14 product categories that will have new management categories (classification), and 7 new additional product categories, along with some other changes.  

This activity has become a recurring process over the last few years as the Chinese NMPA takes steps to help provide manufacturers with more transparency into the registration process. Since the NMPA doesn’t closely follow international classification standards like GHTF or ASEAN MDD, many manufacturers have found that their products’ classifications can differ when registering in China. By providing frequent updates, the NMPA hopes to help manufacturers understand their requirements earlier on in the decision-making process. 

Expected Classification Updates  

Along with adjusting the classification of some products, the NMPA has also proposed creating 7 new product categories, including products for breast biopsy systems utilizing vacuums, absorbable staples, intracranial thrombectomy stents or intracranial thrombectomy devices, and others.  

Additionally, the NMPA has proposed updating the management category (classification) of 14 products including increasing the category for devices such as ultrasonic hemostatic products (II to III) and spinal surgery guide (I to II) while decreasing the category for products such as automatic sample adding systems for IVDs (II to I) and guide wires used for guiding catheters or other interventional devices inserted into a blood vessel. 

A full list of proposed updates can be found here which was translated by Google Translate. For questions about the new classifications, contact us here.