Shanghai Customs and the Shanghai Municipal Science and Technology Commission have issued a joint announcement to initiate a pilot program for facilitating the import of production materials for medical devices within Shanghai.

The pilot aims to foster high-quality development in the biopharmaceutical industry and accelerate the cultivation of new quality productive forces.

An inter-agency coordination mechanism between Shanghai Customs and the Shanghai Municipal Science and Technology Commission has been established to jointly promote the pilot of these facilitation measures.

The scope of the pilot covers imported production materials used by eligible local medical device manufacturers for producing complete medical devices or components. These materials must not be supplied directly to medical device distributors or end-users.

Medical device manufacturers meeting the following criteria may apply to participate: they must be legally registered within Shanghai; possess a Customs enterprise credit rating of Authorized Economic Operator (AEO), Certified Enterprise, or General Enterprise; have a standardized quality and safety control system for production materials; and maintain an information management system or complete process records capable of tracing the usage history of the corresponding materials.

Companies wishing to join the pilot must apply to the district-level biopharmaceutical industry authority where they are registered. After a district authority provides a recommendation, the materials are submitted to the Municipal Science and Technology Commission, which will conduct a preliminary confirmation of the enterprises and products to be included.

Based on this preliminary confirmation, Shanghai Customs will verify the enterprises' credit status and conduct a quality and safety risk assessment, considering factors such as inherent product risk, Customs inspection and supervision history, and risk monitoring information.

Following the preliminary confirmation and assessment results, the Municipal Science and Technology Commission, in conjunction with Shanghai Customs, will determine a "white list" of approved "enterprise + product" combinations for the pilot. Entities and products on this list are referred to as "pilot enterprises" and "pilot products".

When importing pilot products, pilot enterprises must truthfully declare the intended use of the goods to Customs and provide the medical device filing certificate or registration certificate for the pilot product or the related finished product intended for domestic sale.

Pilot enterprises bear primary responsibility for the quality and safety of their imported pilot products. Upon import, they must submit a "Declaration of Conformity for Imported Medical Device Production Materials" to Customs. Customs will verify the consistency of the declared information with the white list, and in principle, will no longer conduct on-site inspections.

Pilot enterprises needing to add or change pilot products or related finished goods must promptly apply to their district-level biopharmaceutical industry authority, providing details such as product codes, names, specifications, countries of origin, manufacturers, and information on the related finished products, including names, subsequent distribution channels, and relevant certificates.

Pilot eligibility will be revoked if any of the following circumstances are verified by the Municipal Science and Technology Commission and Shanghai Customs: submission of fraudulent application materials; refusal to cooperate with Customs inspections or supervision; diversion of pilot products for other uses; import of used electromechanical products as pilot products; failure of imported materials or finished products to meet mandatory national technical requirements, posing potential regional or widespread safety risks; failure to promptly report product recalls or notifications due to quality and safety issues domestically or internationally; or changes causing the enterprise to no longer meet the eligibility criteria outlined in the announcement.

This announcement is effective immediately upon its release.