technical documents.
We need: Business registration of company, ISO certificate, CE, PoA on our company. If manufacturer doesn have CE- we can replace it for registration in country of origin (even if it is not medical device for CFDA).
Approximate cost of registration of product (1 risk class)
№ п/п
| Testing and expertise
| Price
|
1
| State duty for registration
|
|
2
| State duty for expertise
| |
3
| Testing and registration process
|
|
|
The term of registration is from 6 months excluding clinical testing (2-3 months)
Prices indicated in our commercial offer are in force for 1 month
*The price can be changed after giving a specification file on medical equipment.
|