Deep Dive in the Asia Pacific Medical Device Market – China
Welcome back to our articles dedicated to emerging market access. This time we will explore Asia Pacific a bit further. This is the fastest-growing region in the global medical devices market valued at over $105 billion (USD) in 2022!
We already looked at market access in some Asia Pacific markets such as India<link> and Singapore<link> in our articles, with these new items we will take a quick look at a few more Asia Pacific countries, offering an overview of market access for Medical devices, starting with China.
Placing a medical device in the Chinese market – where to start
Foreign manufacturers must register their devices with the NMPA (formerly CFDA) before importing, selling, or distributing in China. The NMPA is the health authority which manages and approves all device applications and has rigorous requirements for submission of documentation, testing, and clinical data for Class II and III devices. Medical devices must have home country approval prior to applying for registration in China and ISO 13485 certification is required.
Foreign manufacturers must assign a China based representative to process registration and listings and represent their interests in China. Manufacturers should ensure their Chinese partners have all the necessary experience and proven expertise to function as their local agent.
Risk classification in China
Medical Devices in China fall into one of three risk types, Class I (Low risk) Class II (Medium risk) Class III (High Risk). There is no technical review for Class I low risk devices.
The process for imported Class I medical devices involves an online filing of device documents with the NMPA. If these are complete and meet the formal requirements a NMPA stamped certificate will be issued immediately. This process can take just a few weeks if the files are well prepared and correctly notarised.
For all other risk classifications manufacturers must submit a technical dossier containing technical information, clinical data, and quality documentation. China may require in-country testing for Class II and III devices, the NMPA may accept some existing testing reports and testing requirements depending on your device type.
China Market Access Summary:
- Assign a person/company to function as your China local agent.
- Determine device classification.
- Determine if clinical trials will be needed for your device. (A feasibility study is recommended)
- Determine the most viable route to NMPA approval.
- Assign UDI numbers.
- Compile the registration application and technical documentation.
- Coordinate product testing in China.
- Prepare final submissions.
- Respond quickly and accurately to supplementary information requests during approval process.
Things to consider:
- Foreign manufacturers without an office in China may need to appoint two in-country representatives.
- Local Agent – They will manage your registration and communicate with the NMPA before and after registration, and during vigilance reporting. This Agent’s name appears on your registration certificate; however, the manufacturer is the MAH owner.
- After Sales Service Provider – responsible for your device after NMPA approval. (Most manufacturers appoint one of their distributors).
- There are pros and cons to using a distributor, consulting firm, or establishing your own offices as local agents, seek further advice and consider this carefully before appointing your agent.
- Application fees for Class II and III submissions can range from $30,000 to $45000 (USD)
and overall costs could run to between $100,000 and $150,000 depending on the device and regulatory pathway required.
- The NMPA uses a Unique Device Identification (UDI) system to improve the tracking and monitoring of medical devices. This system stores device production dates, models, codes, and expiration dates.
- Planning, early feasibility discussions and thinking long-term is key, China is a challenging market to enter but can offer large rewards with successful device approval.
- English and Chinese required for labelling and IFU. All supplied product information, packaging, and labels need to be translated into simplified Chinese.
Please note these offer a general overview of access routes, full pathways and requirements will vary dependent on device type and risk class amongst other variables. If you are interested in placing a device on the Chinese market, do not hesitate to contact us at email@example.com
Regulatory Affairs Consultant