China medical device registration in June 2024 for domestic Class III and imported Class II & III were on trend with overall approvals for the same classes in 2023.
In June 2024, the China National Medical Products Administration (NMPA) approved the registration of 134 medical device products, reflecting a dynamic and rapidly evolving healthcare sector. This monthly figure contributes to the overall momentum seen in 2023, where the NMPA approved a total of 12,213 medical devices for the full year. The comparison indicates sustained regulatory activity and a commitment to introducing innovative medical technologies into the Chinese market.
Breakdown of Approved Products
The approved products are categorized as follows:
- Domestic Class III Medical Devices: 109 products
- Imported Class III Medical Devices: 14 products
- Imported Class II Medical Devices: 11 products
These approvals span a wide range of medical applications, reflecting the diverse needs of the healthcare industry and the advancements in medical technology.
Domestic Class III Medical Devices: 109 Products
- Market Implications: The substantial number of domestic Class III approvals underscores the strength and growth of China’s local medical device industry, particularly in high-risk, high-impact medical technologies. These devices, crucial for advanced diagnostics and treatments, highlight China’s capability to produce sophisticated medical equipment.
- Strategic Insights: Businesses should consider strategic alliances with these domestic manufacturers to harness innovative technologies and meet the rising demand for high-quality medical solutions. For global companies, investing in local partnerships can facilitate entry into the Chinese market.
Imported Class III Medical Devices: 14 Products
- Market Implications: The approval of 14 imported Class III devices demonstrates China’s openness to global medical advancements and its commitment to integrating top-tier international technologies. This category includes critical therapeutic and diagnostic tools essential for maintaining high standards of care.
- Strategic Insights: International firms must prioritize robust regulatory strategies to navigate the NMPA approval process efficiently. Establishing local collaborations and distribution networks will be vital for successful market penetration and growth.
Imported Class II Medical Devices: 11 Products
- Market Implications: The inclusion of 11 imported Class II devices, which cover moderate-risk categories such as diagnostic instruments and surgical tools, reflects a balanced approach by the NMPA in enhancing the healthcare infrastructure.
- Strategic Insights: Companies should tailor their product development and regulatory submissions to align with the NMPA’s specific requirements. Focusing on localizing production and integrating market-specific features can drive acceptance and adoption.
Here are some examples of the imported medical device products registration approved:
The United States continues as the leading importer of medical devices to China, with 12 registrations. Germany, Japan and South Korea who have traditionally been amongst the top 4 importers are also present. This emphasizes the international influence and opportunities within the Chinese market.
There were over 10 different medical device product categories represented among the imported devices. This diversity underscores the breadth of technological innovation and the wide-ranging demand within the Chinese healthcare market. 
Further information
Read the original NMPA announcement on China NMPA approved 134 medical device products registration in June 2024.
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