Receiving a refusal from Roszdravnadzor for an application to amend the registration dossier (IRD) is an unpleasant, but not uncommon, situation. However, the most common mistake manufacturers make is to ignore the issue and continue marketing the medical device. We explore why this approach has become risky.
What has changed in regulation?
The Russian Ministry of Health has expanded the list of risk indicators (amendments to Order No. 368n). Now, the agency automatically identifies companies that simultaneously meet the following conditions:
- received a refusal to make changes to the file, or a return of the application, or a notice of termination of its consideration;
- within 180 working days after this, a re-application was not submitted;
- continue to offer medical products for sale, including online sales.
Consequences for business
The activation of a risk indicator directly triggers an unscheduled inspection by Roszdravnadzor. Such an inspection is coordinated with the prosecutor’s office and does not require a separate complaint—a signal from the monitoring system is sufficient.
During the inspection, the following measures may be applied:
- a fine under Part 2 of Article 6.33 of the Code of Administrative Offences of the Russian Federation – up to 5 million rubles for legal entities;
- suspension of the company’s activities for up to 90 days;
- restrictions on participation in public procurement;
- blocking the release of marking codes.
How to act correctly
The indefinite validity of the registration certificate does not relieve the holder from the obligation to keep the registration dossier up to date.
There are only two legal options:
- Address the regulator’s concerns and resubmit your application. The established 180 business days are sufficient for finalizing the documents.
- Suspend the sale of the product until the dossier is brought into compliance with the requirements.
