Head of Medical Law Practice
Specializes in medical, corporate, and migration law. Has extensive experience working with medical and pharmaceutical businesses, particularly in licensing, circulation of medicines, and comprehensive legal support of healthcare institutions, including corporate, tax, and employment matters, as well as market entry projects of foreign companies into Ukraine.
Case: Expanded the Clinic’s Licence to Launch Laser and Surgical Procedures
Client: A chain cosmetology centre (Kyiv).
Task: Expansion of the licence issued by the Ministry of Health of Ukraine — adding the specialties of “Surgical Dermatology” and “Nursing” to launch device-based and laser procedures.
Regulatory framework: Resolution of the Cabinet of Ministers of Ukraine No. 285 (“Licensing Conditions for Conducting Business Activities in Medical Practice”).
Document preparation time: 2 business days.
Result: An order of the Ministry of Health amending the licensing file was obtained within 10 business days without comments or refusals.
Why device-based and invasive cosmetology requires a medical licence
The modern aesthetic medicine market has moved beyond traditional skincare. The introduction of laser systems, RF technologies and invasive techniques automatically places such services within the category of medical practice.
Providing such services without the relevant specialty included in the licence creates risks for the business:
- fines and confiscation of equipment under Article 164 of the Code of Ukraine on Administrative Offences (conducting business activities without a licence).
- criminal liability in the event of complications suffered by a patient (unlawful medical practice).
- reputational losses and blocking of advertising in Google Ads / Meta Ads due to the absence of licensing confirmation.
Initial case details and the client’s challenges
The client purchased modern equipment (laser systems, microneedling RF devices, SMAS lifting equipment) and hired surgical dermatologists and nurses.
The list of new procedures that required expansion of the medical licence included:
- Removal of skin neoplasms (naevi, papillomas, warts) using surgical and laser methods;
- Fractional laser resurfacing, removal of vascular lesions, pigmentation and scars;
- Combined protocols: Laser + RF lifting, microneedling RF, platelet-rich plasma therapy (PRP);
- Micro- and macro-focused ultrasound (SMAS / HIFU therapy), photorejuvenation.
Main challenge: To prepare updated information on the material and technical resources (MTR) and personnel within a short timeframe in order to prevent downtime of expensive equipment and ensure 100% legitimacy of operations from the first day.
Criteria for the clinic’s readiness to expand its Ministry of Health licence
| Review parameter | Requirements of the Licensing Conditions (Resolution of the Cabinet of Ministers of Ukraine No. 285) | What the lawyers reviewed |
|---|---|---|
| Personnel (doctors and mid-level medical staff) | Availability of a certificate in the specialty of “Surgical Dermatology”/“Dermatovenereology”. Diploma in “Nursing”/“General Medicine”, advanced training courses. | Audit of diplomas, category certificates, professional certificates and employment records. |
| Premises | Compliance with DBN V.2.2-10:2022 (room area, ventilation, lighting, sanitary and hygienic finishes).
DBN V.2.2-40:2018 “Inclusiveness of Buildings and Structures. Basic Provisions” |
Audit of the size of treatment and procedure rooms intended for laser equipment. Availability of a platform lift/lift, ramp slope, double handrails, tactile paving, and Braille duplication of signage. |
| Equipment | Availability of certificates of conformity/declarations of conformity with technical regulations for medical devices. | Legal review of equipment passports and metrological verification. |
Step-by-step support process by Prikhodko & Partners
- Medical and legal audit of personnel: the documents of doctors and nurses were analysed for compliance with the qualification requirements of the Ministry of Health of Ukraine.
- Audit of material and technical resources (MTR): the premises and rooms where microneedling RF, laser treatment and PRP equipment had been installed were reviewed for compliance with sanitary and epidemiological standards.
- Preparation of the document package, application and information: within 2 business days, a complete package of documents was prepared for the new specialties:
- Medical specialty: “Surgical Dermatology”;
- Specialty for junior specialists with medical education: “Nursing”.
- Submission and monitoring before the Ministry of Health of Ukraine: the documents were submitted to the licensing authority with legal support throughout the processing of the case.
Project result
Preparation time: 2 business days.
Ministry of Health review period: 10 business days until the official decision.
Result for the business: An order of the Ministry of Health expanding the list of specialties was obtained. The clinic launched high-margin surgical and device-based services without the risk of inspections, fines or suspension of operations.
Frequently Asked Questions — Expansion of a Medical Licence
Within what period must the Ministry of Health be notified about new doctors or equipment?
Under the Licensing Conditions (Resolution of the Cabinet of Ministers of Ukraine No. 285), the licensee must notify the licensing authority of all changes to the relevant information (new personnel, equipment, specialties, addresses of consulting rooms) within one month from the date such changes occur.
Is a medical licence required for laser hair removal and RF lifting?
If the procedures involve disruption of the integrity of the skin (invasive procedures), involve medical indications/contraindications, or are performed using equipment classified as a medical device (high-powered lasers, microneedling RF, removal of neoplasms), such activities are subject to mandatory licensing by the Ministry of Health.
Why does the Ministry of Health most often leave applications without consideration or refuse licence expansion?
The main reasons are incorrect completion of MTR information tables, discrepancies between the size of the room and the equipment schedule, lack of the required education among doctors, as well as errors when submitting equipment documentation.
Turnkey legal support for a medical business
Prikhodko & Partners is a leading expert in medical law in Ukraine:
- more than 370 successfully obtained and expanded medical practice licences.
- audits of clinics, cosmetology and dental centres before inspections by the Ministry of Health.
- amendments to licences within 10 business days without bureaucratic delays.
Planning to add new services or update the clinic’s staff?
Submit a request on the website or call us to arrange an audit of your licensing file.
Юридичні послуги для медичного бізнесу та лікарів
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