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 is one where it is unclear whether NMPA or another authority (e.g. SAMR for food, or NMPA drug department for drugs) has primary 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.
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.