February 2024 SOCRA Source Journal - Journal - Page 74
TABLE 10:
CER REQUIREMENTS IN CHINA
Three degrees of clinical evidence:
1. On the Exemption List or a Class I device:
• Simplified CER for the first degree of clinical evidence
• Exempted devices include up to 1000 devices, with the majority being Class II and a few Class
III devices
• If device is in the exemptions list, develop a simplified CER:
◦ Product description
◦ Comparison
◦ Discussion on equivalence
◦ Conclusion
2. Regular CER based upon equivalence is the second degree of clinical evidence:
• Equivalent Device must be approved in China
• Equivalence can be established
• Equivalent device has sufficient data
3. Clinical Study Report – is the third degree of clinical evidence
• Update frequency:
◦ Only at approval, indication expansion, or changes
◦ No periodic updates
• Chinese literature review is required:
◦ Chinese patient set search
• MDR recent requirements not required:
◦ Clinical evaluation plan
◦ State-of-the-art current knowledge
◦ Post-marketing clinical follow-up data
• Equivalence:
◦ Must be approved in China
◦ Detailed comparison table
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SOCRA SOURCE © May 2023