NMPA Clarifies Internet Medical Device Transactions via Own Websites No Longer Require Approval

On April 7, the General Office of the State Administration issued a notice on implementing the “Decision of the State Council on the Third Batch of Administrative Licensing Items Designated by the Central Government for Local Implementation to Be Cancelled.”

AtOn the Cancellation of Approval for Internet Drug Trading Service Enterprises Implemented by Provincial Food and Drug Regulatory Authorities (Excluding Third-Party Platforms)Among these measures, the proposal not only calls for the abolition of the Class B and Class C licenses for pharmaceutical e-commerce but also provides detailed specifications regarding “online medical device transactions.”

Enterprises engaged in online medical device trading services,Shall obtain a business license or file for registration in accordance with the law, and conduct business activities within the scope of its license or filing, and promptly inform in writing the municipal food and drug administration department at the districted city level where it is located of information such as the enterprise name, domicile, legal representative, website, and number of the medical device operation license or filing certificate.

1. Medical DevicesManufacturing EnterpriseInternet trading services for medical devices manufactured by the enterprise may be provided through its own website.

(There is no explicit provision here specifying whether the transaction counterparties are individual consumers or B-side clients.)

2. Medical DevicesWholesale EnterpriseInternet medical device transaction services may be provided through their own websites to qualified medical device operating enterprises or user entities, butMedical device transaction services targeting individual consumers shall not be provided.

3. Medical DevicesRetail Enterprisesvia its own websiteProviding Internet-based medical device transaction services to individual consumers, but the sale of medical devices must not exceed the business scope specified in the Medical Device Operation Permit or the Filing Certificate for Class II Medical Device Operations.

4. Medical devices sold at retail to individual consumers shall be suitable for self-use by such consumers, and their instructions for use shall comply with the provisions of Article 10, Item (8) of the Provisions on the Administration of Instructions and Labels for Medical Devices, by including special instructions for safe use.

Relevant policies on the regulation of online medical device transaction services will be issued separately.

Under the 2005 regulations, online pharmacies were required to obtain approval before selling drugs and medical devices; such approval is no longer required. This notice explicitly specifies the requirements for medical devices.Manufacturers, Wholesalers, Retailerstarget service recipients, and those that are explicitly prohibited.

Regarding regulatory and supervisory requirements, food and drug regulatory authorities at all levels must continue to strengthen oversight of online transactions involving pharmaceuticals and medical devices, standardize the entities and conduct engaged in such online transactions, implement effective supervisory measures, and severely crack down on illegal online sales of pharmaceuticals and medical devices.