Consulting and preliminary examination
Document audit, risk class and device type code, registration strategy.
01 / Description
Initial audit of documentation, determination of risk class and medical device type code, selection of registration strategy.
02 / Scope of work
What the service includes
- 01 Initial audit of existing documentation for a medical device
- 02 Determination of the class of potential risk of application and code of the type of medical device
- 03 Selecting the optimal registration strategy (according to EAEU rules or national regulations)
- 04 Consulting on regulatory issues
- 05 Solving non-standard registration problems
- 06 Conducting negotiations and official correspondence with foreign manufacturers
Inquiry form · 24 hours
Enquiry for «Consulting and preliminary examination»
Specify the device type and current registration stage — we will prepare a cost and timeline estimate under Government Decree No. 1684 within 24 hours.