Medical device registration

Issuing timescale: estimated on request

Price: from 2 769 Euro

Validity date: from 150 days up to unlimited

Necessary documents:

- Application form

- Certificate of Incorporation, Tax ID scans

See the full list

- operational documents, including manuals that comply with Health Ministry’s requirements;
- photos of the device with necessary instruments (18x24 cm sized);
- a copy of the document confirming legal authority of the manufacturer’s representative in Russia;
- Declaration of Conformity according to Medical Device Directive (Directive 93/42/EEC);
- ISO 13485
- notice from the Chamber of Commerce
-list of attached documents

Medical devices are products meant for medical use. Hence, everything used for diagnostic, monitoring, treating or preventive purposes is considered medical devices.

Medical devices are to go through a complicated procedure of confirming safety and compliance with existing regulations. Until 2022, companies can certify their products according to the rules of any EAEU member state, for instance, Russia. However, new regulations are about to come into effect and it is a better idea to confirm compliance with them. In other words, it is high time to choose an EAEU medical device registration certificate thought it is more costly.

On the positive side, the mentioned ceritifcate will give you the following advantages:
1) It will give an impetus to your sales in the EAEU market as complying with stricter rules of the EAEU is a ringing endorsement of your product's absolute safety and high quality.
2) It will be valid across the whole EAEU so you will be able to export your product to any EAEU member state without a hitch
3) It will be granted unlimited validity period so you will be able to export your products for years to come

I need Medical device registration of my product, what do I start with?

First and foremost, it would be a good idea to ensure that you really need Medical registration certificate. So on the initial stage all you should do is contact our experts. Just message us in the chat or make a quick call. Our English-speaking manager will be glad to field all your inquires.

As soon as it is clear what you need we will send you a quote including price, terms of issuing and a set of documents required for certification

Whenever you're ready we enter into an agreement and proceed with the certification procedure.

Have questions? Let us clear them up, just book a call or type Hello in the chat.

10% Discount
for 2 Documents

GOST-R Certificate

of Conformity

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Technical Specifications

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ISO 9001

Certificate

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Voluntary

fire safety

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Passport

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Article in Russian Administative Code	Law Violation	Fine / penalty
14.43	Breaching requirements of the Technical Regulations	from 10 000 up to 20 000 rubles on officials, from 100 000 up to 300 000 rubles on legal entities
14.44	Irregularities in permitting documents	from 15 000 up to 50 000 rubles fine on officials and from 100 000 up to 1 000 000 rubles on legal entities
14.45	Improper selling products that require mandatory certification	from 20 000 up to 40 000 on officials and from 100 000 up to 300 000 rubles on legal entities
14.46	Irregularities in product labelling on products that require mandatory certification	from 10 000 up to 50 000 rubles on officials; from 100 000 up to 1 000 000 on legal entities
14.47	Irregularities in product certification process	from 20 000 up to 50 000 rubles or disqualification for 6 months up to 3 years; from 400 000 up to 1 000 000 on legal entities
14.48	Using false test reports within EAEU certification process	from 30 000 up to 50 000 rubles or disqualification for a year (up to 3 years) on officials; from 400 000 up to 500 000 on legal entities