In Reply to Parent Post by Michael Malis
OK - I will give it a try:
First, for registration with SFDA you will need to know product classification (Class 1, class 2 and Class 3, but they are NOT thesame as FDA classes).
Second, what type of device do you have (Medical Device or IVD)?
Third, you will need 3 major groups of documents:
1. License of manufacturer
2. Authorization letters
3. Technical data and IFU
More details for technical documents required for registration in China:
* Biocompatibility data
* Catalog/Model designations
* CE Certificate (if applicable)
* Clinical Summary
* Component/Raw materials/Vendor list
* Declaration of Conformity
* ISO/QMS Certificate
* Letter of Authorization
* Product Description/Indications for use
* Sterilization Method/Location
* Name and Address of manufacturer
* Certificate of Manufacture and Free sale
* Annual Registration of Device Establishment
* Certificate of Free Sales (dependent on country, mostly EU)
* Certificate to Foreign Government (if product made in US)
I am sure that I forget something...
Here's what I've found...
"The Certification and Accreditation Administration (CNCA) is responsible for managing the product approval, for issuing the CCC Mark, and for accrediting certification bodies.
Sixty-eight testing laboratories are recognized by CNCA. Specific product groups are specified for each laboratory and designated certification bodies can only appoint a laboratory according to the CNCA specified list.
The Safety standard is the Chinese GB standard having similarity to IEC and the Chinese EMC GB standard is similar to CISPR. Factory inspection is required with an initial inspection mandatory before certification.
To obtain the CCC Mark, you must meet the following requirements:
Provide two samples of your product
Authorization letter through an agent
Complete CB test report with a CB certificate\Factory inspection report
User manual in Chinese
Valid Chinese certificate of the AC power connector
CCC logo application form"