Regulations on the Management of Export Sales Certificates of Medical Devices Released

On December 25th, the State Drug Administration issued the "Regulations on the Management of Export Sales Certificates for Medical Devices" (hereinafter referred to as the "Regulations"). The "Regulations" will come into effect on May 1, 2026. The "Regulations" are an important measure for the State Drug Administration to implement the "Opinions of the General Office of the State Council on Fully Deepening the Reform of Drug and Medical Device Supervision to Promote the High-Quality Development of the Pharmaceutical Industry" (State Council Office [2024] No. 53), vigorously supporting the export of medical devices and optimizing the service handling of issuing export sales certificates for medical devices by drug supervision and management departments. The issuance of the "Regulations" will provide greater support and more convenient services for the export of medical devices in China, helping Chinese medical device products to accelerate their "going global" and better reach the world, contributing to global public health. This article is excerpted from the State Drug Administration, edited by GMTEight: Chen Wenfang.