Medical devices: a registration certificate instead of a declaration

Medical devices follow their own rules, and this is the first thing to learn. The technical regulations of the Customs Union do not apply to them: looking for a TR CU for a blood pressure monitor or a support bandage is pointless, because there is none. Instead of a declaration there is a Roszdravnadzor registration certificate, instead of weeks there are months, and instead of a testing laboratory there is a whole chain of technical tests, toxicology, clinical evaluation and state expert review.

How to tell that your product is a medical device

What decides is not the appearance or the material, but the purpose that the manufacturer states. A medical device is something intended for prevention, diagnosis, treatment, rehabilitation, monitoring of the state of the body, or restoring its functions.

This creates a paradox that catches sellers: two products that look the same may have a different status.

Potential risk classes

The class determines the scope of testing, the duration and the cost of the procedure. The classification is based on the degree of risk to the patient and on how invasive the device is.

You can determine the class yourself, but a mistake here is expensive: a wrong class means a wrong set of studies and the return of the application. The class is determined by the classification rules, taking into account the purpose, the duration of contact with the body and invasiveness.

What a registration certificate is

The registration certificate is a Roszdravnadzor document that gives the right to put the device into circulation on the market. Without it, a medical device cannot be imported for sale, produced or sold. Neither a declaration, nor a certificate, nor a refusal letter replaces it.

You can check someone else's certificate in the open state register of medical devices. You need to look at the same things as in any register:

• The certificate number exists and the status is valid
• The name of the device matches what is on the packaging
• The manufacturer is the same as the one stated
• The certificate holder is the one who gives you the right to sell
• The models and versions are listed and your item is among them
• The risk class matches the nature of the device

The list of models is the item that is checked least often and that fails most often: the certificate is valid, but the specific version is not included in it.

How registration goes

The procedure has several stages, and the steps cannot be swapped.

1. Technical tests. They confirm that the device meets the stated characteristics and the safety requirements.
2. Toxicological studies. For devices that contact the body — an evaluation of the biological effect of the materials.
3. Clinical evaluation. Either clinical trials with human participants, or an analysis of the existing clinical data — it depends on the class and the novelty of the device.
4. Expert review. State expert review of quality, efficacy and safety based on the submitted dossier.
5. Roszdravnadzor decision and entry in the register.

The timeline is the sum of the duration of each stage, and it cannot be predicted exactly: the clinical part for a high-class device may take longer than all the rest together. Plan the market launch of such a product with a horizon of months, not weeks.

Two procedures: national and under the Union rules

Now two routes exist in parallel. National registration gives a certificate valid in Russia. Registration under the unified rules of the Eurasian Union gives a document recognized in the member states.

• National registration certificate — the usual route; the document is valid in the territory of Russia.
• Registration under the EAEU rules — intended for circulation in several countries of the Union; the application states the reference state and the states of recognition.

The choice depends on where you plan to sell. For a company working only on the Russian market, the national procedure is usually simpler. The rules and the terms of transition between the procedures change — this point should be checked on the date of filing, and you should not rely on last year's experience.

Labelling and documentation

The requirements for accompanying information are stricter for medical devices than for ordinary goods, and they are checked closely.

• The name of the device in the form in which it is entered in the register
• The manufacturer and its address, the country of origin
• The number of the registration certificate
• The serial or batch number, the date of manufacture
• The shelf life or service life
• The conditions of storage and transport
• An indication of sterility and the method of sterilization, if applicable
• The instruction for use in Russian
• Warnings and contraindications

The instruction for use is not an attachment but a part of the device: its content is evaluated during the expert review and must match the registered dossier. A new indication cannot be added to it after registration — this is a change that must be entered in the register.

Marketplaces and medical devices

The platforms treat this category more strictly than any other, because the responsibility here is heavier.

• Require the registration certificate before the card is published, not on request
• Compare the name in the card with the register — a mismatch leads to a block
• Check the right to sell, if the certificate was issued to someone other than you
• Moderate the wording: a promise of a therapeutic effect for an ordinary product is a reason for a block and a complaint
• Restrict advertising of some categories

The most frequent mistake of sellers in this niche is to sell a product “for health” with medical wording without having a registration certificate. The product may be completely harmless: the problem is not in the product, but in the stated purpose. What the platforms request in general — in a separate article.

Typical mistakes

Action plan

• Answer honestly whether you state a medical purpose — everything else depends on it
• If yes — determine the potential risk class before starting work
• If no — remove the medical wording from the packaging, the card and the advertising
• When buying from a supplier — check the registration certificate in the register and the presence of your model in the list
• Get confirmation of the right to sell, if the certificate is not issued to you
• For your own registration — allow months, not weeks, and a permit for importing samples
• Agree the instruction for use as a part of the dossier, not as a marketing text

If after the check it turns out that there is no medical purpose, the product returns to the ordinary system of technical regulation — and then the starting point will be the analysis of product lists and the choice of the document form. For cosmetics with borderline claims, the analysis of TR CU 009/2011 is useful.