Bryan Gilburg - China

“China’s three-tiered, risk based classification system generates lots of confusion from manufacturers. Here is a welcome effort from the NMPA to create more clarity.”

Bryan Gilburg

Managing Director

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

China’s NMPA Publishes Classification Catalogue Adjustments for Comment

Published on: November 8th, 2022

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 

Identifying a Predicate Device 

Despite all of these new classifications from the NMPA, identifying a predicate device (also known as a “same-type” device in China) is still vital to avoid clinical trials and prolonging market access for your product.  

Additional information about the China clinical trial exemption list can be found on our website, as well as more general information about identifying predicate devices in Asian countries, including China 

For further questions on NMPA device classification or identifying a predicate device in China, please contact us here 

Come Grow With Us

Whatever the scenario, Asia Actual has regulatory experts throughout Asia ready to help your device expeditiously achieve market access and begin, or continue, growing your sales in the region.  

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services. 

Sign Up For Our Newsletter to Stay Informed

Sign Up

Blog Posts

China Continues to Implement UDI of Medical Devices with Third Batch Release

The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.

USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices

Learn about the recent Virtual Regional Workshop on Good Regulatory Practices and Medical Device Regulation hosted by USAID, ANSI, and AdvaMed. Attendees gained valuable knowledge on navigating the complex world of medical device regulation, including discussions on specific GRPS, WHO global model regulatory framework updates, and country experiences with reliance models. Read on to discover the benefits of recognizing foreign conformity assessment results, transparency, predictability, inclusion, consistency, and accountability.

Vietnam Extends Validity of Medical Device Import Licenses

On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.