China

Country Information:

China, the world’s most populous country with over 1.4 billion people, is rapidly expanding its healthcare system. The capital, Beijing, and other cities like Shanghai and Guangzhou have state-of-the-art healthcare infrastructure. China is also experiencing a surge in medical device consumption due to its aging population, rising healthcare awareness, and government initiatives like «Healthy China 2030.»

Medical Devices Market Size:

China’s medical device market is one of the fastest-growing in the world, estimated at USD 72 billion in 2023. The market is highly diverse, with significant growth in diagnostic imaging, surgical devices, and in vitro diagnostics (IVD). The import market is substantial, but local production is increasing as China aims to become more self-sufficient in medical device manufacturing.

Future Growth Potential:

The medical device market in China is expected to grow at a CAGR of 10% from 2023 to 2028. Factors contributing to this growth include:

• Increased demand for high-quality medical devices in underserved areas.

• Rising affluence and a growing middle class that demands better healthcare services.

• Strong government policies encouraging innovation in the healthcare sector.

• Expanding insurance coverage and increased healthcare budgets.

Registration Process:

Registration of medical devices in China is managed by the National Medical Products Administration (NMPA). The process involves:

• Classification: Devices are categorized into three classes based on risk: Class I (low risk), Class II (moderate risk), and Class III (high risk). Clinical trials may be required for higher-risk devices.

• Local Agent: Foreign manufacturers must appoint a local agent to facilitate the registration process.

• Required Documentation: Proof of home country approval, ISO certifications, clinical data (if applicable), and technical documentation in Chinese.

• Testing: Devices are often required to undergo testing at an NMPA-accredited facility in China.

• Approval Timeline: The registration process typically takes 6 to 12 months, depending on device classification and the need for clinical trials.

Other Information:

• The Chinese market is highly regulated, with frequent updates to NMPA requirements.

• Companies entering the market must be prepared for in-country testing and local agent involvement.

• MDSAP certification is increasingly being accepted by NMPA, expediting the process for manufacturers already compliant with international standards.

China (NMPA Registration Process) Flowchart:

1. Classify Device
   → Class I, II, III

2. Appoint Local Agent
   → Required for foreign manufacturers

3. Prepare Documentation
   → Proof of home country approval, ISO certificates, clinical data

4. Testing in China (if applicable)
   → Conducted by an NMPA-certified lab

5. Submit Registration Application to NMPA
   → Online submission or through agent

6. Approval by NMPA
   → Issuance of Registration Certificate