Q: How long does medical device registration take?
A: The timeframe depends on the device's risk class:

• Class 1: 6–9 months
• Class 2a: 8–12 months
• Class 2b: 10–15 months
• Class 3: 12–18 months

This includes dossier preparation, laboratory testing, expert review by Roszdravnadzor, and issuance of the Registration Certificate (RC).

Q: What is the cost of medical device registration?
A: Pricing depends on the risk class, device type, and whether clinical trials are required:

• Class 1: from ₽350,000
• Class 2a: from ₽500,000
• Class 2b: from ₽750,000
• Class 3: from ₽1,200,000

Note: Fees for testing laboratories and clinical centers are not included and are billed separately.

Q: Is an Authorized Representative mandatory?
A: Yes, if the manufacturer is registered outside the EAEU. An Authorized Representative is a mandatory requirement for both initial registration and maintaining the validity of the Registration Certificate. The Representative must be a legal entity registered in one of the EAEU member states.

Q: Can I register a device directly under EAEU rules?
A: Yes. Until December 31, 2027, applicants may choose between national registration procedures (Russian Federation) or the unified EAEU framework. After this date, all new registrations will follow EAEU rules exclusively.

Q: What if I need to modify an already registered device?
A: You must apply for an amendment to the existing Registration Certificate. The procedure takes 1 to 6 months, depending on whether the changes are classified as substantial or non-substantial. Certain modifications may require additional testing or expert review.

Q: Is ISO 13485 certification required for registration?
A: For EAEU registration, ISO 13485 certification is mandatory for most device categories (except Class 1). For national registration in the Russian Federation, the certificate is not always compulsory but significantly accelerates the review process.

Q: Can registration be refused?
A: Yes. Common reasons for refusal include:

• Incomplete or poorly prepared dossier
• Negative testing results
• Insufficient evidence of safety and efficacy
• Documentation errors

Our company maintains a 96% success rate thanks to rigorous pre-submission document review and quality control.

Q: How long is a Registration Certificate valid?
A: Starting from 2026, Registration Certificates are issued indefinitely (no expiration date) under both national and EAEU procedures. However, holders must keep the technical dossier up to date and submit amendments in a timely manner when changes occur.

Q: Can software be registered as a medical device?
A: Yes. Software as a Medical Device (SaMD) is subject to registration if it is intended for medical purposes such as diagnosis, treatment, monitoring, or disease prevention. Required documentation includes technical specifications, algorithm descriptions, and validation reports.

Q: What documents are needed to get started?
A: Minimum initial package:

• Device description and intended use
• Technical documentation (drawings, specifications, materials)
• Instructions for use (if available)
• Power of Attorney for the Authorized Representative (for foreign manufacturers)
• ISO 13485 certificate (if available)

We assist clients in preparing any missing documentation and ensuring full compliance with regulatory requirements.