As we know, Roszdravnadzor is a supervisory body. It controls the circulation of medical devices and medicines, quality and safety of medical activities, etc.
Respectively, any medical device has a good chance to be inspected by Roszdravnadzor, where any registration data inconsistency may be detected.
As a result, a medical device may be withdrawn from circulation in some cases, which potentially results in large losses even for a relatively small enterprise. And if we talk about a large-scale producer participating in public procurement, such product withdrawal may be really disastrous.
Our specialists have extensive experience in resolving issues related to:
- Suspension of the use of medical devices - Withdrawal of medical devices from circulation — Recognition of medical devices as unregistered, substandard or falsified.
What Shall We Do for You?
We offer services of support during the inspection and solution of issues thereafter. We help a manufacturer mitigate any risk as much as possible and, if a crisis occurs after the inspection, address it as smoothly as possible.
Our services:
- Consultation on the resulting control and supervisory activities;
- Introduction of amendments into the manufacturer’s documentation;
- Preparation of letters and requests to Roszdravnadzor;
- Interaction with law enforcement agencies;
- In case of initiation of a criminal case, provision of a qualified lawyer.
We do everything to ensure that your loss of money and time is minimal.