The path of a medical device: from idea to commercialisation from a regulatory perspective

The main point: registration is not the finish line

The most common mistake — made not only by newcomers but by experienced manufacturers — is picturing a medical device's life cycle as a straight line: develop the device, prepare the documentation, implement a quality management system, pass inspection, run the testing, obtain the registration certificate.

This approach loses. Every company that follows it runs into an enormous number of problems.

The reason for the mistake is easy to understand. Everyone is chasing an MVP — a minimum viable product you can sell. But with medical devices you can only sell after registration. And once a company fixates on getting that entry in the register as fast as possible, almost everything else drops out of view.

What gets overlooked

Procurement and equipment standards. When an equipment standard changes, demand for particular device types changes with it — in either direction.

Taxation. VAT rules for medical devices change abruptly.

The "second-is-out" and "third-is-out" rules in public procurement. These restrict foreign bidders when domestic offers are present. They can push you out of the market entirely — or make you highly sought after if your device is localised.

Post-market surveillance. Once the registration certificate is granted, the device falls under the regulator's magnifying glass, where every wrong move leads to administrative and — with medical devices, frequently — criminal liability.

Post-registration obligations. Registration is not the end of the Cinderella story; it is where the relationship with the regulator begins. Keeping a registration certificate valid requires continuously performing more than twenty distinct actions.

Restrictions. Medical devices cannot be advertised freely. Some rules work in the manufacturer's favour and some against.

An example working against you: if your company acts as an authorised representative and imports devices from abroad, any other legal entity can use your registration certificate — the one you paid for and lost sleep over — to import the same device. Registration confirms that the device is of good quality, effective and safe. It does not confirm that you hold an exclusive supply contract.

An example working for you: if you find counterfeit or falsified copies of your device on the market, you will not have to pull them yourself. Circulation of counterfeit and falsified medical devices is policed far more aggressively than consumer goods, and the Investigative Committee responds quickly.

Continuous modification. Innovative devices rarely stand still. The typical situation: the registration certificate is granted, and the very next day a variation procedure begins.

The mechanics matter here. When you file for registration, you declare a specific device description, its characteristics, photographs and test results. If the colour, design, description, indications or performance change, the process starts over: run testing on the changes, refile, wait for a positive decision. Only then can the modified device be sold.

A fast, stripped-down registration certificate often serves as a milestone for securing subsidies and grants — and then causes serious problems. Roughly 80% of the problems affecting registered medical devices sit below the waterline.

The real life cycle, and the budget

Registration is the very first and the shortest stage of the life cycle. After it come procurement, variations, restrictions, surveillance and post-registration obligations. Set the team up for the whole cycle, not just for the certificate.

The same goes for the budget. Producing the sample, developing documentation, translations, inspection, testing and state fees account for roughly half the total. The other half is needed for variations and post-registration obligations.

Mapping the regulation: what affects a medical device

To make sense of the mass of documents bearing on a medical device, Alina Mustafina maintains an open knowledge base on medical device registration and circulation. Access is free; documents are sorted by category and split across two tracks — Russian national regulation and EAEU regulation — because many rules are duplicated across both and operate differently in each. Every document carries its entry-into-force and expiry dates.

The categories that affect a device:

Registration rules — national and EAEU.

Requirements for technical documentation content — in the EAEU these are split across two documents.

Testing rules — the EAEU devotes three documents to this.

Classifiers and nomenclatures — risk class and device types.

Devices as measuring instruments. If a device incorporates measuring instruments, special rules apply.

Import and export.

Regulatory inspections. Manufacturers, authorised representatives and even testing laboratories are subject to scheduled and unscheduled inspections. Roszdravnadzor Order No. 1 of 2022 gives a good sense of what inspectors will look for.

The list of risk indicators. This order describes which actions earn a company a black mark. The document is deliberately vague: you know a risk indicator has been assigned, but the regulator does not disclose what follows from it.

Post-market surveillance. Continuous monitoring of registered and unregistered devices: procedures, the company's obligations on detecting an adverse event, and the adverse event classifier.

Circulation of unregistered devices. Not every medical device requires registration. A large category does not, but requires a special circulation procedure. Unregistered in vitro diagnostic devices, for example, may be used provided the manufacturing and use rules are observed within one and the same institution — but this requires authorisation.

Retail, exchange, sale of used devices, replacement during repair. On used devices, the Ministry of Health and Roszdravnadzor have issued conflicting guidance.

Advertising. The restrictions are serious and differ fundamentally from the rules for services and consumer appliances.

Certification. Only one category of devices is subject to certification, but marketplaces may still demand certificates — the platforms are not always aware the law has changed. In 2022, marketplaces were blocking product listings for precisely this reason.

Clinical investigations involving human subjects. The procedure is demanding and rarely required: since 2024, out of roughly 7,000 medical devices, only 22 needed clinical investigations involving human subjects.

Procurement. The "second-is-out" and "third-is-out" rules, the rules for recognising a device as manufactured in Russia, and lot formation requirements.

Localisation. Simply labelling a product "Made in Russia" is not enough — there is a separate substantiation procedure overseen by the Ministry of Industry and Trade.

Special circulation and registration regimes — decrees covering devices for combating COVID-19 and devices facing exceptional demand due to sanctions, plus the commissions and instruments for handling shortages and emergencies. Some remain in force; some have been repealed.

Medical software incorporating artificial intelligence. The regulator takes the view that such software must undergo a special testing procedure, for which methodological guidelines have been developed.

A separate order requires that any registered AI-enabled medical software include embedded code that automatically transmits data on the software's outputs to Roszdravnadzor's AIS system. It is currently impossible to register and circulate software that operates in isolation — all software registered in Russia must include this data-upload functionality.

The case of the AI device procurement guidelines is instructive. Regions are required to procure at least three AI-enabled medical software products each, but choose which ones themselves. The registered documentation lacked the necessary wording, so a variation had to be filed purely to match the guidelines and remain eligible for public tenders. The document has no special legal status, yet regions follow it — which means it affects both circulation and registration.

The same applies to the Roszdravnadzor list of approved domestic AI-enabled medical devices. There is no formal procedure for getting onto it, but after obtaining a registration certificate the company must initiate contact with the regulator itself — otherwise regions will simply pass it by.

Registers. The status of the register has risen sharply: since 2025, no paper registration documents are issued at all — much as paper title deeds for real estate were discontinued. How the device is described in the register is the only thing procurement officers will consult. Errors and typos must be corrected immediately.

Registers exist under both national and EAEU rules. Separate registers cover: medical organisations engaged in manufacturing and custom production; nomenclature classification; testing centres; organisations that have and have not passed manufacturing inspection; custom-order devices; and devices removed from the nomenclature.

Quality management system — implementation requirements, inspection procedure, cost. Under national rules it is impossible to calculate the inspection cost yourself: the formula is such that only the regulator can apply it.

Labelling, including the Chestny Znak track-and-trace system. Pilots ran on large equipment — CT scanners and similar, which rarely enter circulation. High-volume categories are now being brought in, starting with medical gloves.

Post-registration reporting. The company must report every unit imported or placed on the market. For Class 3 and implantable Class 2b devices, a clinical performance report is additionally required: for three years after registration the company collects data from users on outcomes of use. Dedicated forms are developed for this — effectively a miniature clinical investigation on real-world users.

Electronic document flow. The move to electronic filing made 2025 a difficult year. National filings now go exclusively through the Gosuslugi public services portal; the paper registry office is closed entirely; reporting has been fully digitised. The filing process has become technically demanding and often requires help from IT specialists.

Licensing. The manufacturing licence has been abolished; the technical servicing licence remains. If a device requires servicing or special permits for assembly and installation, this is done either in-house or through a licensed company.

Non-medical items within a medical device. If an X-ray table ships with a computer, mouse and keyboard, separate documentation is required for the monitor and system unit — you cannot simply include them in the kit.

Taxation. VAT rates are 0%, 10% and 20%. Last year a legal conflict arose: the Tax Code required a registration certificate to be submitted to the tax authority, but certificates had already been discontinued in favour of register extracts. Because of an uncorrected phrase in the Code, the tax authority withheld the VAT relief for a long time. Beyond the Code itself, a steady stream of supplementary clarification letters is needed.

Subsidies and compensation.

Criminal and administrative liability for violations in medical device circulation.

Litigation: what medical device disputes are actually about

A medical device litigation intelligence service helps keep track of criminal and administrative practice. It collects court cases, categorises them and describes in plain manufacturer's language who sued whom and how it ended.

The picture is varied:

• disputes under Federal Law 44-FZ on public procurement;
• B2B disputes between purchaser and supplier;
• VAT disputes;
• cases under Article 238 of the Criminal Code — counterfeits, falsified products, unregistered devices;
• customs disputes;
• cases brought by the Federal Antimonopoly Service, especially over advertising;
• fines, predominantly against medical organisations that procure something incorrectly;
• disputes with Roszdravnadzor over refusals of state registration. Roszdravnadzor does not lose often, but it does lose. The antimonopoly service loses more frequently;
• disputes with Roszdravnadzor over calibration and verification;
• surveillance disputes, where a company disagrees with a decision.

A distinct category concerns whether a product qualifies as a medical device at all. The situation arises like this: a device type is discontinued, new registrations are refused, but a competitor's existing registration certificate is not revoked. When a tender opens, whoever holds a valid certificate wins automatically, because the medical organisation does not understand the regulatory nuance and only checks whether one exists.

Device compatibility is a large problem in its own right, and receives enormous attention. Standalone medical devices are rare — a scalpel qualifies, but most products are medical systems where devices operate together. The case law is contradictory: one medical organisation was fined for using incompatible devices, while a company was fined and ordered to remove information stating that its devices were incompatible with others, so that this would not affect procurement.

The available registration routes

National procedure under Government Decree No. 1684

The main advantage is an established registration approach: thousands of devices are registered this way each year.

But the regulator wants the market to move to EAEU registration. Certificates issued under the national route cannot be amended after 31 December 2028, and the filing window is limited. Given that a year is the standard registration timeline, the national route now looks less attractive: you may simply run out of time to file before the end of 2027.

Government Decree No. 552 — expedited registration in response to sanctions

A 2022 decree with two functions: rapid substitution of raw materials used in registered devices through an accelerated variation procedure, and rapid registration of device types abandoned by departing foreign manufacturers where demand persists.

To use the route, the device type must appear on a specific list. The main advantage is no manufacturing inspection. Testing follows standardised programmes, though whether that counts as an advantage is debatable.

The constraint is the validity period of the resulting certificates. After the cut-off date new devices cannot be placed on the market, while units already released may circulate until their shelf life expires. The deadline has already been extended three times, and if shortages persist another extension is likely — but there is no guarantee.

Government Decree No. 430 — devices for pandemic response

Ultra-fast testing, no inspection, but a very narrow list of eligible device types. It was created largely for the rapid registration of ventilators. Its validity period is limited and has likewise been extended three times.

A good procedure, but an unpopular one: while thousands of devices are registered annually under the national route, Decrees 552 and 430 account for dozens.

Registration under EAEU rules

The principal advantage is a single procedure covering five countries: Russia, Kazakhstan, Kyrgyzstan, Belarus and Armenia. Testing is done once, documents are prepared once, expert review happens once and manufacturing inspection happens once. Registering separately in each country would mean paying for inspection every time.

The drawbacks are a slightly longer timeline, because of the member-state coordination stage, and slightly greater complexity, because each country raises its own requirements during the procedure. Russia's requirements are the strictest, so clearing them means a 99% chance of clearing the rest.

The registration procedure, step by step

It starts with a sample. Not with documents — with a sample in the form in which you intend to sell the device. This is a critical point for startups: registration does not happen at the idea stage, but once a sample exists.

Then the documentation is developed. Design documentation is not submitted to Roszdravnadzor — the regulator has its own requirements for how documents are to be created specifically for registration purposes. Technical and operational documentation is prepared, along with the rest of the checklist.

Then testing — technical, toxicological, clinical, measuring-instrument testing, sterility testing. Conducted in independent accredited laboratories.

With the test results, the company approaches the regulator. The documentation and results are reviewed. The sample itself is never provided to the regulator — the regulator looks at how the sample performed in accredited institutions. At this stage questions and objections typically arise; the outcome is either refusal of registration or a single opportunity to address the listed objections.

Manufacturing inspection. Under national rules it takes place during development or testing, in parallel; under EAEU rules it comes later. Inspection applies to sterile Class 2a devices and to Classes 2b and 3 — and note that all AI-enabled software falls automatically into Class 3.

The inspector visits the manufacturing site and verifies that the production line exists, that labels are not simply being reapplied to imported goods, and that development genuinely takes place at the declared location. Even for software, the inspector travels to where the computers stand and the developers sit. The second thing to demonstrate is the quality management system documentation.

For the EAEU there is an additional coordination stage. You may select between two and five countries; the remaining countries re-examine the documents and may raise objections of their own, which must also be resolved.

What it costs

The figures below come from Alina Mustafina's own commercial proposal for EAEU registration. These are costs paid separately and directly to the providers.

Testing a medical device in Russia

Testing is paid directly to the laboratory, and the exact cost is set by the laboratory or medical institution. Delivery of samples to testing laboratories — including from abroad — and customs clearance of samples, including import VAT, are paid separately.

Technical testing depends on the device: nuclear medicine equipment and a linear accelerator undergo different tests. Toxicological testing is required wherever there is contact with the human body — patient or clinician, any type of contact. Examination gloves without blood or invasive procedures sit at the lower bound. A resorbable implant sits at the upper bound: the material must be implanted in animals and observed as it resorbs.

Clinical investigations

Conducted at organisations on the Roszdravnadzor list — state and private alike, on a commercial basis and only where special authorisation is held.

These are floor prices. In Alina's own practice, a clinic quoted RUB 8 million for clinical investigations involving human subjects on a single Class 2a device.

What matters here is which tests are actually required. If the device is not innovative — an ultrasound scanner, a scalpel, an X-ray unit — and an identical product already exists on the market, you can skip human-subject investigations and instead run a detailed comparison against a registered comparator device. Unlike pharmaceuticals, medical devices have no Phase I, II and III — it is simpler.

State fees for EAEU registration

Fees from each participating country are cumulative.

Manufacturing inspection

In Russia, roughly RUB 2 million: the service itself starts at a million, plus flights, accommodation and visas for the inspectors.

Kyrgyzstan is considerably more forgiving — charged per manufacturing site under Order No. 1422 of the Kyrgyz Ministry of Health, dated 28 November 2023. The cost depends on actual headcount.

Only production staff count — accounting and cleaning personnel are excluded. Headcount also determines how many inspectors travel.

Postage, document execution and translation

This covers postal and courier costs for delivering documents to the reference state, printing, execution and binding of documents, and certified translation. Not all 69 documents are translated — only labelling and operational documentation.

When working with foreign documentation, translation into Russian is a given — the terminology is highly specific.

Authorised representative services

Relevant only to foreign companies: without legal representation you cannot register a device. Domestic manufacturers do not need an authorised representative.

The service covers reporting, submission of adverse event information, reports and corrective actions (up to three per year, further ones at extra cost), and keeping the dossier documentation current. Compiling the dossier in XML format is charged separately.

Four factors that drive up the cost of registration

Lack of regulatory foresight. The first and most expensive factor. You need to account in advance for future modifications, compatibility and indications, so as not to constrain the device's further development — the restrictions on variations are severe. At initial registration, think through how the device will circulate, what it will work with, which indications it will be used for, and in which patient age groups.

Clinical investigations involving human subjects. An immediate two- to threefold increase in cost and timeline.

No finished sample. You must first set up serial production, manufacture the quantity needed for testing, then pause everything and wait for the certificate. A frequent startup mistake is going into testing with an alpha version or an unfinished device. The registration certificate will cover exactly what was tested, and will not extend to future modifications.

Artificial intelligence. Subject to a special, more demanding registration procedure.

New rules on clinical investigations involving human subjects

The rules change from 1 September. The previous logic was clear: a new device type, new technology or new materials meant human-subject investigations.

Two further grounds have been added.

A design change affecting the intended purpose or operating principle. Where such a change is made to a registered device, human-subject clinical investigations are required. The key problem is that whether a change has such an effect is determined by the regulator. A company may make a design change and find that the regulator considers it to affect the intended purpose, sending the device off to expensive investigations.

Expansion of the list of indications for use. Also now grounds for human-subject clinical investigations. This ground did not previously exist at all, and indications are changed frequently.

How to demonstrate a comparator and avoid clinical investigations

Demonstrating that your device has an existing comparator requires a substantial body of data. An unsupported assertion will not do.

There may be several comparators — their number is not capped. In Alina's practice there was a case involving comparison against ten comparator devices simultaneously: equivalence on one criterion was found with one device, on another criterion with a different one, and the full equivalence picture could only be assembled that way.

The practical implication: when developing a device, start by searching for registered comparators and analysing how they worded their intended purpose. Then word your own device's purpose in similar terms — comparability becomes far easier to demonstrate.

What gets compared

General information: name, variants, delivery kit, manufacturer, registration certificate number (for registered devices), device type, product classification code, risk class, operating principle. Some of these are mandatory — discrepancies on those mean equivalence will not be accepted.

Clinical information: intended purpose, field of application, indications, severity and stage of the disease or condition, contraindications, side effects, precautions, intended user, patient group, restrictions on use and on combined use with other devices, concomitant therapy, post-use recommendations, and required clinician qualifications.

This also covers unique clinical parameters — for a hyaluronic filler, for instance, the expected duration of the cosmetic effect. The point ties back to standards: for cotton wool you compare absorbency, for a bandage tensile strength at break. It must be assessed individually by device type.

Biological safety (where there is contact with the body): material of manufacture, body parts in contact, type of contact — invasive, implantable, non-invasive — duration of contact, biocompatibility, sterility, methods of sterilisation, cleaning and disinfection, number of permitted uses and restrictions, biodegradation period, viral safety.

Implantable devices are sent for human-subject investigations more often than any other category, because a complete match on material of manufacture cannot be found. In implants it is the material itself that performs the device's function, so even a minor change in the ratio of components means, to the regulator, an absence of equivalence.

Technical parameters: principal dimensions, mass, service life, unique technical parameters, and physical, mechanical and chemical properties. Multi-component devices are compared part by part: ultrasound scanners cannot be compared as whole units — transducer against transducer, light source against light source.

For implants, additionally: whether removal is required, wear characteristics, implantation methods, degradation characteristics. For active devices running on battery or mains power: power source, runtime per power source, presence and type of wireless data transmission, presence of software, compatibility functions.

The comparator's regulatory history. Using the registration certificate number, check whether any safety information notices have been issued.

Operation: special recommendations, conditions of use, transport and storage, servicing, repair, disposal.

Appearance. For a small device, simply top and bottom; for a large one, better element by element.

What to do about differences

Once the table is complete, the discrepancies found are sorted into material and immaterial.

Immaterial ones require justification. A difference in runtime, for example, can be explained by the comparator having been registered five years ago, when lithium batteries had lower capacity. Justification is needed even for differences where your figure is the better one.

Discrepancies in risk class are also described — for instance, the comparator's risk class was higher because the kit included suture material, whereas the comparison concerns the needle.

If the differences are material and cannot be justified, additional testing will be needed so that the results can establish equivalence.

If the table holds up and the devices really are similar in appearance and characteristics, registration does not require human-subject clinical investigations.

Three principles of commercialisation

Plan ahead. The regulatory strategy should be built not up to the point of obtaining the registration certificate, but up to the point of its withdrawal — whether voluntary or by the regulator's decision.

Play by the rules. The typical attempts to work around the regulation: hiding the artificial intelligence and calling it an algorithm to avoid the demanding procedure; leaving part of the functionality undeclared while demonstrating it during sales, because it is the unique selling point. The regulator knows all of these schemes, and criminal and administrative liability applies.

The severity of the regulation means small teams cannot afford to bring a device to market alone: you either raise investment or a grant, or develop the idea within a large corporation. But medical devices are not consumer appliances — high risk class, high likelihood of affecting a patient, mass application. These rules of the game have to be accepted.

Be transparent. An open dialogue with the regulator and with testing centres, and an honest statement of what the device can and cannot do, speeds up the route to market.

Sometimes that means hard decisions. One case from practice: during testing, two of twelve fields of application for a medical software product had to be dropped. In another, a team abandoned registration entirely, because there was not enough money for full clinical investigations to demonstrate efficacy and safety.

Why a regulator is needed at all

Alina Mustafina began her answer with the thalidomide story. The example concerns pharmaceuticals, but it applies in full to medical devices.

A truncated drug registration procedure was in place, and thalidomide reached the market — a drug indicated for nausea in the first trimester of pregnancy. There was no demanding registration procedure, no testing, no clinical investigations. Women began taking the drug, and thalidomide children started to be born — children without limbs.

The only country to escape was the United States. Frances Kelsey, an official at the regulatory agency, told the manufacturer the drug would not be admitted to the market until a specific form of clinical research had been conducted. The company decided not to enter the American market at all: the procedure was too demanding, and European sales were going well anyway.

When the tragedy came to light, Frances Kelsey received an award from President Kennedy — for making the regulation difficult and introducing the research requirements that protected the market.

Which gives a simple answer to the question. Regulation is demanding because otherwise thalidomide-scale tragedies would keep recurring. High-risk-class medical devices cause very serious harm when something goes wrong. That is precisely why there are so many requirements, both during registration and after it. There are also cases in the other direction — where post-registration requirements stopped comparable tragedies involving already-registered devices.

How the regulator is structured

The lead authority for medical devices is Roszdravnadzor. But it does not conduct the expert review itself: documents are not read within the agency. Two expert organisations exist for that — VNIIIMT and the National Institute of Quality. Both are subordinate to Roszdravnadzor, there are exactly two of them, and this is firmly fixed: medical devices throw up a great many contested questions, and conflict situations require an outside opinion. They are funded from the state fees.

Roszdravnadzor receives the registration documents and forwards them to one of the two.

A device is never reviewed by a single expert. A panel is convened from specialists in different fields. On Alina Mustafina's own team these were typically a chemist responsible for toxicology, an engineer responsible for design, and a physician. All three are given simultaneous access to all the device data and conduct their analysis in parallel.

Each of them reviews the complete document set, not just their own area, so that nothing is missed. But when a contested toxicology question arises, the toxicologist decides.

Each expert produces conclusions, which most often take the form of objections. A responsible secretary is appointed to consolidate the objections of all three panel members into a single document. That document passes several review stages — first the lawyers, then Roszdravnadzor itself — before reaching the manufacturer.

The manufacturer either addresses the objections and refiles, or withdraws. On re-examination the panel takes one of two decisions: admit the device to market subject to post-registration obligations — there is no such thing as a perfect dossier, and that is the expert's baseline position — or issue a reasoned refusal of state registration with the grounds stated. There is no limit on how many times you may file.

Where the manufacturer's money goes

Technical, toxicological and clinical testing is paid on a commercial basis. These are market relationships with accredited testing centres — not just any laboratory may test devices, only one holding specific authorisation. There are around a hundred such organisations for technical and toxicological work.

Clinical investigations are conducted by medical institutions, state and private alike, likewise on a commercial basis and likewise only where specific authorisation is held.

Expert review is conducted by the two subordinate institutions: they check what the laboratories produced.

The state fee goes to the budget.

Inspection is paid to whoever travels: one of the subordinate institutions for an inspection in Russia, or the corresponding EAEU country.

Translation goes to translation agencies, and authorised representative services to the legal entity providing them.

How to navigate the regulatory framework

First, go by dates. The knowledge base records when each document takes effect and when the preceding one ceases to apply. If a date is close, it makes sense to work to the new document straight away; when a new edition is approved, switch to it.

Second, use the categories. A category-sorted document list helps establish priorities. The base has a smart keyword search: even if a document is not filed under "inspection," the search will surface every document where inspection is mentioned.

Genuine conflicts in the legislation are now almost gone — the regulator has cleared them up. Two remain: the divergent wording on used medical devices, and the difficulties around clinical investigations of Class 3 and Class 2b devices under EAEU registration.

But mastering this body of material on your own in a week is impossible — there are many documents, and none of them runs to two or three pages. On top of that there is a large layer of unwritten rules, not set down verbatim in any regulation, known to the specialists who work in the field continuously.

A specific case: a new order issued mid-testing

The answer: read the order's preamble. Take Order No. 421 — it states that conformity assessment for tests whose applications were submitted by the manufacturer or authorised representative to the testing laboratory or medical organisation before the order took effect is carried out under Order No. 885.

So if the testing application was registered with the testing centre before 1 September, you may test under the previous order. If you did not file in time, the new one applies.

Each order has its own entry-into-force nuances: for some the trigger is the date the testing application was filed, for others the date the state registration application was submitted via Gosuslugi. All of it is set out in the preamble.

How to check whether a startup is ready to file

First, work through the checklist of 69 document types and confirm the manufacturer has each one. The checklist is her own: the official checklists in the published documents did not satisfy Alina Mustafina, so she reworked and extended them into something more detailed.

The documents fall into categories:

• on the device — technical file, operational documentation, risk management file, sterilisation information, normative documentation, labelling, photographs;
• on the manufacturing process — information on the developers, production flowcharts, the contract between manufacturer and manufacturing site where these are different legal entities, an information letter on the manufacturing processes;
• finance — state fees for registration, for expert review, for EAEU coordination, payment for inspection;
• testing — qualification batch, technical, toxicological, measuring-instrument testing, stability studies;
• on the manufacturer — details, certificates, company registration, supporting documents; where the manufacturing site is a separate legal entity, its certificates and ISO certification. A power of attorney is no longer required now that filing is electronic;
• clinical data;
• production materials — where there is contact with the human body, a passport, certificate or declaration of material quality is required. For purchased medical devices within the product: if a hyaluronic implant is supplied in a syringe with a needle made by a different manufacturer, documentation for those is needed too;
• trademark — this receives close attention. There is already a case of a state registration being revoked for infringement of intellectual property rights, and with an entirely non-innovative device at that;
• manufacturing inspection.

Second, check the documents on content. Content requirements — for the technical file, for example — are in the knowledge base. But even checking for presence alone is a major step forward: often documents are simply missing.

It helps to understand the regulator's logic here. If a document is absent or its content is insufficient, the regulator is obliged by the rules to send a query specifying exactly what is missing. So it is better to complete documents thoroughly — it makes the regulator's job easier.

But where information is provided and does not correspond to reality, the situation is different. Example: the technical documentation declares a dimension of 100 cm with a 1 cm tolerance, and testing shows 115 cm. The device falls outside the tolerance, and the discrepancy on that dimension leads to the device being deemed non-compliant.

Materials shown during the webinar

• Knowledge base on medical device registration and circulation An open catalogue of regulatory documents by category, for Russia and the EAEU, with entry-into-force dates and smart search
  Open
• Medical device case law The litigation intelligence service: cases under 44-FZ, B2B disputes, VAT, Article 238 of the Criminal Code, antimonopoly proceedings, customs and disputes with the regulator
  Open
• Grants and subsidies for medical device manufacturers An overview of non-repayable grants: which institutions provide funding, amounts, stages, requirements and direct links to providers
  Open
• Registration document checklist The 69-document checklist by category
  Telegram VK MAX
• Comparator comparison table template and feedback form The instrument used to demonstrate equivalence and avoid human-subject clinical investigations
  Open
• Minutes of the VNIIIMT and National Institute of Quality scientific expert councils Specific rulings from the two subordinate organisations: variations, disinfection, sterility, hyaluronic acid, polynucleotides, classification as a medical device, risk class, AI software
  Open
• Supervision Risk categories, scheduled and unscheduled inspections, documents needed to prepare for an inspection
  Open
• Register of authorisations for clinical investigations involving human subjects Maintained since 2024; lets you check whether a comparator device was sent for human-subject investigation
  Open
• Clinical investigations Where to conduct them, document templates, the clinical investigation protocol, new requirements
  Open

Contact. Alina Mustafina, medical device regulatory specialist · Email: am@promeddev.com · Telegram: @mamovivo