Drug Device Combination
Products
The National Medical Products Administration (NMPA) defines drug-device combination products as medical products composed of both drugs and medical devices, integrated into a single entity.
To register a combination product with the NMPA, you must first determine the product’s Primary Mode of Action (PMOA):
If the device PMOA is unclear, applicants can apply for an attribute definition from the NMPA’s Center for Medical Device Standards Management (CMDSM) before submitting the premarket approval application.
Joint Evaluation of Drug Device Combination Products
During a joint evaluation, the CDE and CMDE collaborate to assess the product's safety, effectiveness, and quality control. Each center issues an evaluation report covering its respective component, and the leading unit consolidates these findings into an overall evaluation report. This report is then submitted to the relevant NMPA department for administrative approval.
For drug-led combination products, the CDE leads the evaluation. If a joint evaluation is required, the application dossier is transferred to the CMDE for synchronized evaluation.
For device-led combination products, the CMDE leads the evaluation. If a joint evaluation is required, the dossier is transferred to the CDE.
During a joint evaluation, the CDE and CMDE collaborate to assess the product's safety, effectiveness, and quality control. Each center issues an evaluation report covering its respective component, and the leading unit consolidates these findings into an overall evaluation report. This report is then submitted to the relevant NMPA department for administrative approval.
Our China Drug-Device Combination Product Services
With expertise in both pharmaceutical and medical device regulations, we assist with the classification, registration and compliance of both drug and device-led combination products.
Our services include:
Regulatory Pathway Assessment
Registration Strategy Development
Dossier Preparation & Submission
Clinical Trial Application (CTA)
Communication & Coordination with Regulatory Authorities
Post-Approval Compliance
Request a Proposal from Our Life Sciences Team about Your Combination Product
Let Cisema help turn your plans into reality.
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