For manufacturers

Medical device registration in Russia

We prepare the registration dossier, organise testing and support the registration with Roszdravnadzor — from the manufacturer’s documents to the entry in the state register.

Get an estimate Scope of work

≈ 13 months: indicative, from the start of work to the state register entry
31 working days: the registration procedure itself, excluding replies to comments and additional requests
5 + 1: preparation steps + registration

From the manufacturer’s documents to the entry in the state register

01
Legal documents
- Request, receipt and evaluation of the manufacturer’s documents
- Power of attorney, authorization and notification letter templates
- Apostille and RF notarization
02
Technical documentation
- Request, receipt and translation
- Preparation of the registration dossier documents
- Answers to additional requests
03
Testing
- Technical, EMC, toxicology
- Clinical
04
Registration dossier
- Compilation of the dossier
- Final review before submission
05
Application submission
- Submitting the application for registration
✓
Registration
- Decision on registration
- Entry of a record into the state register

Indicative timeline

Our work plan for a foreign manufacturer takes about 13 months; we confirm the exact schedule after reviewing the documents. Some work runs in parallel: we compile the technical documentation while the legal documents are being apostilled and notarized.

01 Legal documents

02 Technical documentation

03 Testing

04 Registration dossier

05 Application submission

✓ Registration

≈ 13 mo · State register entry

Step timelines depend on how quickly the manufacturer submits documents and on their quality.
The registration procedure takes 31 working days, not including the time required to respond to possible comments or additional requests.

What we need from the manufacturer

Legal documents

For apostille and notarization. We provide the power of attorney and letter templates.

Technical documentation

On the device — plus answers to additional requests while the dossier is being prepared.

Test units

For technical, EMC, toxicology and clinical tests — by the start of the testing stage.

The faster and more complete the manufacturer’s documents are, the closer we keep to the schedule.

MedGrade experience

Case: registration of the Perlove PLX118F C‑arm

MedGrade is the applicant and the authorized representative of the manufacturer for the registration certificate of the PLX118F mobile digital X-ray C‑arm. The manufacturer is Nanjing Perlove Medical Equipment, China.

Device in our catalogue (in Russian)

Registration certificate: No. RZN 2024/22815
Registered on: 5 June 2024
Current record date: 20 August 2026
State register status: Valid

FAQ

How long does medical device registration take?

Our work plan for a foreign manufacturer takes about 13 months from the start to the entry in the state register. The registration procedure itself takes 31 working days, not including replies to comments and additional requests. We confirm the exact schedule after reviewing the manufacturer’s documents.

How much does registration cost?

We calculate the cost for a specific device after reviewing the manufacturer’s documents. Leave a request and we will send you an estimate and a schedule.

What documents do you need from the manufacturer?

Legal documents for apostille and notarization, and the technical documentation on the device. We prepare the power of attorney, authorization and notification letter templates and translate the technical documentation.

What tests does the device go through?

The work plan includes technical, EMC, toxicology and clinical tests. The manufacturer provides test units for them. We define the test scope for your device when preparing the estimate.

Estimate and schedule

Get a registration estimate for your device

Send us the manufacturer’s documents — we will review them and confirm the schedule.

Or contact us directly

Sergey Golubev · Head of Regulatory Affairs

regulatory@medgrade.pro Phone+7 925 111-01-88 Telegramt.me/medgrade_gsv

WeChat ID wxid_w1wiollddfvc22