NMPA Announces Suspension of Import, Distribution and Use of Coloplast A/S Foam Dressings (Announcement No. 75 of 2026)

On August 11, 2026, the National Medical Products Administration (NMPA) officially issued Announcement No. 75 of 2026, announcing the immediate suspension of the import, distribution, and use of foam dressing products manufactured by Coloplast A/S (Registration Certificate No.: NMPA Imported Medical Device Registration 20163144881).

According to the announcement, the NMPA conducted a remote inspection of Coloplast A/S, focusing on its foam dressing products (Biatain Foam Dressings). The inspection identified deficiencies in the company's quality management system, particularly in design and development as well as quality control, raising product quality and safety concerns.

To ensure the safety of medical devices for public use, and in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production, the NMPA has taken the above decision.

This action once again demonstrates the NMPA's strong commitment to stringent oversight and quality assurance of medical devices. Healthcare institutions and patients using the affected products are advised to stay informed and make necessary adjustments accordingly.