China

As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward. Exempted Products will still need to submit a Clinical Evaluation Report (CER) but will save considerable time and money. Since its inception, the Clinical Trial Exemption List has been an important factor for foreign manufacturers considering entering the Chinese market as the Clinical Trials can be redundant, costly and time consuming. For a product type to be added to the Exemption List, the NMPA must see the device’s technology as mature with a proven history of safety and effectiveness or find that clinical trials with this type of product are not feasible.

Learn more about the newly drafted Clinical Trial Exemption List here.

Clinical Trial Alternatives

For products not on the Clinical Trial Exemption list, they will likely have 3 options:

1. Conduct a local clinical trial which is expensive and time consuming,
2. Provide evidence from overseas clinical trials which can be tricky as it may not meet local expecations,
3. Identify 3 predicate devices and conduct a thorough comparison to show the safety and efficacy, along with a robust Clinical Evaluation Report (CER).

China Clinical Evaluation Reports

Clinical Evaluation Reports (CERs) are a vital part of the registration process in Europe, China and many other markets. CERs generally comprise of 2 main parts, device-specific clinical evidence and a literature review. The clinical evidence portion provides information on specific clinical data collected by the manufacturer on the product while the literature review uses public information to provide evidence that the technology used for the intended uses has been shown to be effective by third parties.

Contact Asia Actual to learn more about your clinical requirements in China.