Medical Device Manufacturing License Cancellation in Russia: Complete Guide to New Requirements

Medical device manufacturers in Russia no longer need production licenses since 2022, as the government shifted to ISO 13485-based quality control and simplified market entry procedures.

What Changed in Medical Device Licensing in Russia

Since March 1, 2022, Russia has fundamentally transformed its medical device manufacturing regulation system. The government abolished mandatory manufacturing licensing, replacing it with a more efficient quality control and safety system.

Key Timeline Changes in Medical Device Licensing in Russia

• April 30, 2021 - Adoption of Federal Law No. 128-FZ of April 30, 2021: The official document is called "On Amendments to the Federal Law 'On the Fundamentals of Health Protection of Citizens in the Russian Federation' and Articles 12 and 22 of the Federal Law 'On Licensing of Certain Types of Activities'". Simply put, this is the law by which the state completely rewrote the rules for medical device circulation in Russia and removed the old requirement to obtain a manufacturing license.
• March 1, 2022 - complete abolition of manufacturing licensing in Russia. The date when Government Resolution of the Russian Federation No. 2129 of November 30, 2021 came into force. The document approved new Provisions on licensing activities for technical maintenance of medical devices and simultaneously established that medical device manufacturing in Russia no longer requires a license.
• Until January 1, 2024 - transition period for reformatting technical maintenance licenses in Russia. The old comprehensive license was called: "Production and technical maintenance of medical equipment". After Federal Law No. 128-FZ (April 30, 2021) abolished the medical device manufacturing license in Russia, the state needed to "cut off the excess" and leave only what is actually controlled - technical maintenance. Article 3 of 128-FZ prescribed an obligation for all holders of old "production-service" licenses: by January 1, 2024, reformat them to the new license "Technical Maintenance of Medical Devices" (activity type code 78).

Brief History of Medical Device Licensing in Russia: From Introduction to Cancellation

Evolution of Manufacturer Requirements in Russia

Period	Requirements	Regulatory Base	Status
2007-2013	Medical equipment manufacturing license	Government Resolution No. 33 of January 22, 2007	Abolished in 2013
2013-2021	Medical device manufacturing license	Federal Law No. 99-FZ "On Licensing"	Abolished in 2022
From 2022	ISO 13485 + inspection + registration	Federal Law No. 128-FZ, Government Resolution No. 136	Currently active

What the Old Medical Device Regulation System in Russia Represented

Before 2022, medical device manufacturers in Russia were obligated to:

1. Obtain Manufacturing Activity License

The factory received a license for a 5-year term. To obtain it, they needed to: show owned/leased workshops and equipment; hire specialized personnel (higher/specialized secondary education + ≥3 years experience); have technical documentation and internal quality control; collect dozens of copies of title documents and certificates.

2. Annually Confirm Compliance with License Requirements in Russia

The license was perpetual only subject to periodic confirmation. Once every three years (often wrote "annually" - because additional documents were submitted every year) the company:

• Submitted to Roszdravnadzor a package of reports and document copies
• Paid state duty (7,500 rubles) and waited for "complies/does not comply" response
• In case of non-compliance, received a directive and could lose the license

3. Separately Register Each Device in Russia

For each model, a registration dossier was compiled: technical specifications, test results, clinical data, label layouts. The dossier was submitted to Roszdravnadzor, testing centers and expert organizations checked documents and samples. The output was a Registration Certificate (RC) - without it, selling and importing the device in Russia was prohibited.

4. Undergo Various Types of Control and Supervision in Russia

Three "layers" of inspections operated simultaneously:

License control - planned/unplanned inspections (checked premises, personnel, journals, equipment).

State control of medical device circulation - selective sample collection, documentary inspections, control purchases.

Safety monitoring - obligation to report adverse reactions, batch defects, conduct investigations and recall products. (Basis - Article 38 of Law 323-FZ + Ministry of Health orders).

Reasons for Medical Device Manufacturing License Cancellation in Russia

Main Government Policy Motivations

1. Regulatory Guillotine in Russia

The government systematically eliminated duplicating administrative barriers that:

• Did not increase actual product safety
• Slowed innovative solution market entry
• Created excessive bureaucratic burden

The license only checked the presence of workshop, personnel and journals, while the safety of the devices themselves was already assessed during state registration. The factory first underwent inspection to obtain a license, then experts came to the same site to conduct an inspection when registering the first medical device model. Thus, double checking added on average 2-3 months in time and about 40-70 thousand rubles in duty expenses to bringing each device line to market in Russia. As a result - up to 5 inspections per year, none of which concerned the clinical effectiveness of devices.

After amendments were introduced by law No. 128-FZ (April 30, 2021), the word "production" itself disappeared from Articles 12 and 22 of law 99-FZ; control was transferred to the format of ISO 13485 inspections.

2. Harmonization with EAEU Requirements in Russia

The Eurasian Economic Union initially built regulation on the principles of:

• ISO 13485 quality management systems
• Registration of specific devices
• Production inspection control

Now a Russian manufacturer after one inspection and one dossier gets access to 5 markets at once: Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan.

Mutual recognition of inspections: Roszdravnadzor inspection is now accepted by other Union regulators - this saves up to €15-20 thousand on "repeat audits".

Alignment with EU/USA: Focus on QMS and post-market surveillance coincides with MDR (EU) and QSR (USA), facilitating future export beyond EAEU.

3. Import Substitution Acceleration in Russia

This became especially relevant during the COVID-19 pandemic, when it was required to:

• Quickly scale up medical equipment production
• Reduce barriers for new manufacturers
• Stimulate domestic developments

The 2020-2021 pandemic showed that a delay of months between project and medical device implementation in Russia could practically cost thousands of lives. As a result, market entry for medical device startups was significantly simplified: without a license, they could immediately manufacture small batches of products while working toward the final Registration Certificate.

According to EEC data, the medical equipment market turnover in EAEU grew by 14% in 2021, and the share of Russian manufacturers in government purchases of ventilators and laboratory consumables rose from 42% to 68% over two years.

New Medical Device Regulation System in Russia: What Replaced Manufacturing Licenses

Three Pillars of Modern Medical Device Production Control in Russia

1. ISO 13485 Quality Management System

• Mandatory implementation of GOST ISO 13485-2017 standard
• Documentation of all production processes (from design to service)
• Risk management and corrective actions (ISO 14971, CAPA)
• Ensuring complete product traceability (raw materials → batch → serial number)

GOST ISO 13485-2017 is an analog of international ISO 13485, completely dedicated to medical devices. A certificate is not required: instead, the factory every 5 years presents a Roszdravnadzor inspection report.

What this means for manufacturers in Russia:

• Without documented QMS, Roszdravnadzor will not accept the device registration dossier
• All forms of evidence (procedures, records, risk management plans) are stored throughout the entire designated service life of the device + 2 years
• When changing site, suppliers of "critical" processes or sterilization lines, an unplanned inspection will be required

2. Roszdravnadzor Inspection Control in Russia

• Primary inspection before production start (Conducted before registering the first model or in parallel with dossier submission for registration. They check QMS in action, personnel completeness, premises/equipment, validation of critical processes)
• Planned inspections every 3 years (Check CAPA implementation, process changes, internal audit effectiveness)
• Unplanned inspections upon complaint receipt (Check incident causes, violation elimination, technical documentation relevance)
• Quality system compliance verification with stated requirements

Inspection period - up to 90 working days; report is valid for 5 years and applies to all devices of the same manufacturer at the same site. Cost (according to Order No. 726n) can reach 2.4 million rubles including VAT.

Key documents that will definitely be requested during Roszdravnadzor inspection in Russia:

• Quality policy and manual
• Risk management procedures, design, sterilization, traceability
• Input/output control records, calibration and process validation
• Product labeling and instructions, including information for the "Honest MARK" system (for groups where labeling is already mandatory)

3. State Device Registration in Russia

• Obtaining a Registration Certificate (RC) for each model
• Conducting necessary tests and studies
• Clinical trials for high-risk devices
• Post-marketing safety monitoring

After obtaining a Registration Certificate (national or EAEU format), the manufacturer is obligated to:

• Label the device in the "Honest MARK" system (the phased list is constantly expanding: from 2024 - CT scanners, stents, hearing aids, etc.)
• Conduct post-marketing monitoring - collect and transmit to Roszdravnadzor reports of any adverse effects/defects and initiate recall when suspected health threats exist. (Basis - Ministry of Health Order No. 175n.)
• Report all changes in design or manufacturing process: some such changes are processed by notification, while "significant" changes require amendments to the Registration Certificate.

What Still Requires Licensing in Russia

It's important to understand: only licensing of medical device manufacturing was completely abolished. The following still require licensing in Russia:

• Technical maintenance of medical devices
• Medical equipment repair
• Instrument verification and calibration
• Complex equipment installation and setup

Consequences of New Medical Device Regulation System Implementation in Russia for Business

Advantages of the New System in Russia

For Manufacturers:

• Reduced market entry time by 2-3 months
• Lower administrative costs (Now the one-time inspection fee is about 65 thousand rubles and is paid once every 3 years. Fewer payments and duplicate document packages - significant savings in time and money)
• Possibility of parallel registration process management (Inspection, testing and clinical studies go simultaneously, significantly reducing the waiting period that existed before: first obtaining a license - then obtaining a Registration Certificate)
• Simplified access to EAEU country markets (One Registration Certificate according to EAEU rules + one audit = product access to the entire union territory, saving up to €15-20 thousand. Possibility to participate in EAEU tenders.)

Positive statistics in Russia:

The average regulatory dossier review period in 2024 decreased by 19% compared to 2021 thanks to eliminating the unnecessary "licensing pause".

The share of Russian devices in government equipment purchases grew from 42% to 68% since 2021 - officials directly link this to introducing accelerated registration procedures.

For Consumers in Russia:

• Improved actual product quality (ISO 13485 audit evaluates real processes and CAPA; Non-compliance with stated requirements results in the manufacturer receiving a directive from the regulatory authority or product batch recall)
• Enhanced safety control (Every serious adverse event is entered into the federal system - failure to submit a report threatens the manufacturer with fines up to 1 million rubles)
• Faster appearance of innovative solutions (A startup can launch a pilot batch without spending time obtaining a manufacturing license)
• Competition development and price reduction

New Medical Device Regulation System Requirements in Russia

Increased Manufacturer Responsibilities:

• Need for serious quality system investments (In 2024, Roszdravnadzor rejected 27% of applications due to "QMS non-compliance")
• Constant maintenance of high production standards
• Enhanced control over suppliers and components (Supplier must undergo second-party audit or present ISO 13485 certificate. All changes (glue, chip, fabric replacement) are classified as "non-significant" or "significant" changes (the latter require Registration Certificate amendments). When defects are detected, batches are tracked by serial number to the end customer within ≤ 48 hours).
• Mandatory product monitoring after release

What Business Should Do to Benefit from New Medical Device Regulation System in Russia

• Build QMS "top-down": Not "papers for papers' sake", but competently constructed, interconnected processes: risk management, validation, traceability.
• Plan inspection parallel to R&D: While designers bring the device to "finished sample", auditors from the inspecting party are already conducting inspection in the workshop.
• Invest in digitalization: ERP-MDR ("Big accounting" + warehouse + production in one software and journal of all complaints and incidents with medical device after sale) - this combination allows reducing post-marketing labor costs by up to 30%.
• Look at EAEU immediately: Union format dossier costs more initially, but on the second-third model saves tens of thousands of euros.
• Learn from bad examples: Roszdravnadzor publishes quarterly reports on document recall reasons. Seek specialist help in time.

Where Medical Device Regulation in Russia and EAEU is Heading

Medical Device Regulation Trends in Russia

1. Stricter Clinical Data Requirements

New State Registration Rules (Government Resolution No. 1684 from March 1, 2025) require submitting expanded clinical evaluation reports even for some Classes I and IIa medical devices, while for Classes IIb/III "living" dossiers with updates every 3 years are introduced. The report now includes literature analysis, real data and ISO 14971 risk matrices - without them, expertise simply won't begin.

2. Enhanced Post-Marketing Surveillance in Russia

The current Government Resolution No. 1113 requires annual safety reports from manufacturers in the first three years after registration and immediate Roszdravnadzor notification of incidents. In 2023, the agency received 8,000 such reports - twice as many as before the reform.

3. Rapid Incident Response System Development

The EEC Board approved the concept of a unified medical device market. By 2026, a "unified unsafe product showcase" launches, where regulators from five countries will upload alerts similar to the European Safety Gate. This will allow blocking dangerous batch sales across EAEU territory within hours.

4. Electronic Dossiers and Document Flow in Russia

Government Resolution 1684 introduces the ability to upload materials directly to the Roszdravnadzor portal, signing them with qualified digital signatures. Paper document versions will be accepted only until the end of 2026.

5. Online Production Process Monitoring in Russia

Since 2024, remote site inspections via video conference are permitted (Government Resolution No. 135). Inspectors simply request online factory tours, quality control sensor downloads and ERP log copies from manufacturers.

6. Safety Reporting Automation in Russia

Roszdravnadzor accepts post-marketing report files in XML format. Companies with ERP integrated with MDR module ("Big accounting" + warehouse + production in one software and journal of all complaints and incidents with medical device after sale) generate packages in minutes and link to serial numbers. Major players reduced PMS labor costs by 30% this way.

7. Harmonization with FDA and CE Requirements

Through Russia's participation in IMDRF (International Medical Device Regulators Forum), non-compliance assessment methods (N66:2024) were updated and transition to common "Summary Technical Documentation" format is being prepared - the same package reviewed by FDA and notified bodies.

8. Mutual Inspection Recognition

IMDRF presented a draft "playbook" for reliance programs: regulators will first be able to recognize only inspection reports (Stage 1), and by 2028 - marketing authorization decisions. EEC plans to test the model in 2026 on Classes I-IIa.

9. Russian Manufacturer Export Potential Development

One EAEU registration already opens manufacturer access to five-country markets. The new "Concept-2025" adds online Registration Certificate renewal and simplified English dossier translation - to submit to FDA (TAP) or CE without complete rework.

Expert Support in New Medical Device Regulation Reality in Russia

The cancellation of medical device manufacturing licensing in Russia became a logical step within modern regulatory policy. The new system, based on risk management principles and continuous quality control, creates more efficient conditions for industry development.

Manufacturers who perceive new requirements as opportunities for competitiveness enhancement will gain significant advantages in Russia's developing medical technology market.

LLC "UCEC QUALITY" company possesses deep expertise in medical device registration and is ready to provide comprehensive support at all stages - from quality management system implementation to obtaining Registration Certificates. Our specialists will help efficiently adapt to new legislative requirements and minimize risks when bringing products to the Russian market.