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Borderline and Combination Products

Some products fall at the intersection of multiple regulatory categories — medical device, drug, biologic, cosmetic, or food. These are borderline products (界定产品) or combination products (组合产品) and require a specific determination before registration can proceed.

Borderline products (界定产品)​

A borderline product (界定产品) is one where it is unclear whether the NMPA medical device department or another authority—such as SAMR (State Administration for Market Regulation) for food products, NMPA's drug department for pharmaceuticals, or industry-specific regulators—has primary regulatory jurisdiction.

Process: Apply to NMPA for a product attribute determination (产品属性界定). NMPA will assess the product and issue a written determination. The determination binds the regulatory pathway.

Drug-device combination products (药械组合产品)​

Where a product combines a medical device and a drug, classification depends on the primary mode of action (主要作用原理):

  • Device primary action → classified and registered as a medical device (with drug component subject to drug approval)
  • Drug primary action → classified and approved as a drug (with device component subject to device standards)

NMPA's National Centre for Drug Evaluation (CDE) and CMDE co-ordinate on combination products. There is no formal combination product office equivalent to the FDA OCP.

Device-biologic combinations​

Devices incorporating human tissues (e.g. bone grafts), animal tissues, or cells are subject to additional requirements. Class determination is made case-by-case.

Cosmetic-device boundary​

Beauty devices (e.g. some laser devices, ultrasound devices for skin treatment) may be classified as medical devices depending on their claimed mode of action. A cosmetic claim does not exempt a product from device regulation if it meets the MDSAR 2021 definition.

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.

When applying for a product attribute determination (产品属性界定), manufacturers should submit a formal request to NMPA with technical documentation describing the product's composition, intended use, mechanism of action, and claims. NMPA typically issues a written determination within 60 days. This determination is binding and must be obtained before formal registration. Multiple NMPA departments may be involved if the product involves both devices and drugs or other regulated categories. The determination letter should be retained as it is required as supporting documentation in the registration dossier.