China Medical Device Registration
To register medical devices in China, foreign manufacturers must first appoint a local NMPA Legal Agent to act as their representative throughout the product lifecycle. (NMPA stands for the National Medical Products Administration, which is China’s regulatory authority responsible for medical devices).
The approval process, whether a registration or filing/notification, depends on the device’s risk classification, which is determined by the NMPA’s Medical Device Classification Catalogue, and is updated every year or so. If a product is not listed in the catalogue, manufacturers can refer to the "Rules for Medical Device Classification" or request an official classification from the NMPA.
At present, a home country approval is required, however, the NMPA has recently issued a draft law which is intended to replace current regulations. And it is expected that these registration requirements will be removed.
Class I Devices
Manufacturers must submit a filing or notification application with technical information, test reports, and quality documentation. Upon approval, the device is listed in the NMPA database, and a Certificate of Filing is issued with indefinite validity unless modified.
Class II & III Devices
Manufacturers must submit a registration application. These devices require local type testing, either a local Clinical Trial or a China compliant Clinical Evaluation Report (CER), and a Quality Management System review.
Our China Medical Device Registration & Filing Services
We guide you through every step of the China medical device registration process. We take care of compliance with NMPA requirements, advising you on the optimal market entry pathway, test methods and helping you through the whole process to achieving your medical device registration certificate.
Our services include:
- Predicate devices
- Overseas clinical data
- NMPA standard filings for class I & registrations for class II and class III devices
- NMPA Innovative Medical Device route
- Hainan Medical Tourist Pilot Zone
- Greater Bay Area Approvals (requiring prior Hong Kong Listing)
- NMPA Priority Review
- Emergency Approval
- Conditional Approval
Explore Related Services
Whether you’re just starting out or are a blue-chip, access our wide range of services and solutions to help your business thrive.
NMPA Legal Agent
We are your authorized representative in China, and fulfill your registrations and filings as well as ensuring compliance with quality and PMS requirements.
NMPA Type Testing
We provide end-to-end support for China type testing in NMPA-accredited laboratories. Our experienced test engineers offer on-site supervision to guarantee accurate and reliable results.
China Clinical Trials
You may be required to provide supplementary clinical data on Chinese patients or conduct a full clinical trial in China.Our clinical research team will advise you, prepare the study protocol and assist setting up the clinical trial in China.
NMPA Clinical Evaluation Report
CERs can avoid the need for a China clinical trial in some instances. Our experts can advise and prepare NMPA compliant CERs.
Drug Device Combination Products
We assist with the classification, registration, and compliance of combination products in China, whether drug or device led.
China Medical Device Quality Compliance
We help you achieve and ensure ongoing compliance with Chinese requirements.Our experts prepare and assist you for official NMPA inspections.
Medical Device PMS & Vigilance
The NMPA is placing greater focus on Post-Market Surveillance (PMS) such as more in-market sampling inspections and regular standard changes.
Regulatory Outsourcing
If you are seeking specific specialist expertise or have ongoing resource-intensive needs, we have a variety of solutions to meet your needs.
