Guangzhou’s Huangpu District Streamlines Class I Medical Device Filing for Enterprises

The Huangpu District Government Service Center in Guangzhou announced on the morning of August 18 that, effective immediately, local manufacturers of Class I medical devices can complete filing procedures within the district, making the process significantly more convenient for enterprises.

To ensure a smooth and effective transfer of responsibility for Class I medical device filings, the Huangpu District Administration for Market Regulation has introduced an innovative “One Body, Two Wings” approval service model. Under the model, the Approval Management Section stationed at the government service center is responsible for receiving application materials, issuing notifications of filing numbers and manufacturing filing certificates, and managing records. The Guangzhou Huangpu District New Drug Application Service Center is responsible exclusively for core technical reviews, enabling seamless coordination between the administrative authority and the technical review body.

Enterprises may submit applications online through the Guangdong Government Service Network or the website of the Guangzhou Municipal Administration for Market Regulation. They may also submit materials in person at the food and drug service counter of the district government service center.

The entire process strictly follows the operating procedures of the Guangzhou Municipal Administration for Market Regulation and adheres to the principle of “no lowering of standards, no relaxation of requirements and no compromise on quality,” ensuring an orderly transfer, smooth implementation and efficient operation of the filing services.

Text and photos by Lu Mengqian, Guangzhou Daily/Xinhuacheng