《医疗器械出口销售证明管理规定》发布 明年5月1日起施行

Core Viewpoint - The newly released "Regulations on the Management of Medical Device Export Sales Certificates" by the National Medical Products Administration (NMPA) aims to support the export of medical devices and optimize the process for obtaining export sales certificates, effective from May 1, 2026 [1][2]. Group 1 - The regulations specify that applicants wishing to export medical devices registered or filed in China must apply to the provincial drug regulatory department for a "Medical Device Export Sales Certificate (I)" [1]. - For medical devices not registered or filed in China, applicants must apply for a "Medical Device Export Sales Certificate (II)" to prove that the product is managed as a medical device in China but is not registered or filed [1]. - The validity of the export sales certificate should not exceed the earliest expiration date of the various documents submitted by the enterprise [2]. Group 2 - The export sales certificate for Class I medical devices is valid for a maximum of three years [1]. - If the validity period expires or if there are changes in the content of the export sales certificate, a new application must be submitted [2]. - The publication of these regulations is expected to provide broader support and more convenient services for the export of medical devices, facilitating their entry into global markets and contributing to public health worldwide [2].