Class I Medical Device Registration (STED) requirements in China

D

delvynh

Hello dear regulatory community,

i am new in the field of medical device registration in P.R. China and would like to know whether a STED (GHTF) is mandatory for the application and how detailed it should be?

Am I right, that no product testing is needed to register a Class I product?

Thanks in advance for your answers.

DH
 

sreenu927

Quite Involved in Discussions
Hi delvynh,

Welcome to Cove:)

For Class I product registration in China, following docs are required:
1. Labels-English and Chinese
2. User Guide-English and Chinese (intended use and product description covers in user manual)
3. ISO 13485 Cert (may need notarisation)
4. Free Sales Certificate from Country of Origin
5. packaging information
6. histroy of recalls/AEs
7. Manufacturer-distributor agreement
8. Business ACRA-notarised
9. Manufacturing info(process flow chart+ISO 13485 cert)
10. Other declaration letters (product standard letter, Clinical Trials declaration letter, after-sale agreement letter, quality confirmation letter, etc..)

Currently, SFDA doesn't allow GHTF's sTED format for submitting the product registration application.

All the documents, along with the application form, your distributor can directly submit to SFDA.

Hope this helps!

Regards,
Sreenu
 
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