Distribution of medical devices in Belarus
Distribution of medical devices in Belarus
FAQ. How much does it cost to register medical devices and to find a reliable distributor in Belarus?
FAQ. How much does it cost to register medical devices and to find a reliable distributor in Belarus?
Global medical manufacturers partner with us to unlock new growth through three core pillars:
đ¤ 1. Strategic Market Entry & Distribution
- Top-Tier Partners: We identify, vet, and secure long-term contracts with financially stable importers and distributors.
- Direct Network: We build trusted relationships with hospitals, clinics, Key Opinion Leaders (KOLs), and medical universities.
- Fast-Track Registration: Complete your medical device registration in just 4â5 months (for EU MDR certified products) or 6â7 months (for national export certificates).
- Turnkey Dossier Management: Full preparation of labels, IFUs, and Technical Information (TI) in Russian and Belarusian.
- Cost Efficiency: Save 25% on professional translation and notarization of your technical dossier.
- Targeted Promotion: We organize specialized webinars, seminars, and medical exhibition booths.
Maximise your market presence in Belarus with expert medical consulting and strategic distribution partnerships.
Authorised Representative Contract (Medical Consulting)
- Fee: âŦ500 (One-time payment)
- Focus: Full regulatory compliance and representation.
- Fee: âŦ900 / month (Minimum 3 months; price negotiable)
- Focus: Identifying, vetting, and securing long-term contracts with reliable local distributors.
Guaranteed Quality & Safety
- What it means: Official state registration validates the premium quality of your medical equipment.
- The process: We guide your products through rigorous local laboratory testing to ensure 100% compliance with national standards. [1]
- What it means: Expand your sales pipeline immediately.
- The process: Registration grants you unhindered access to state tenders, public procurement, and high-value contracts with top distributors.
- What it means: Protect your margins and lower operational costs.
- The process: A valid registration certificate is a mandatory prerequisite for unlocking local tax privileges and exemptions.
Your product must be registered if it falls under any of these 4 categories:
- New Imports: Foreign products entering Belarus for the first time.
- New Local Products: Devices manufactured in Belarus for the first time.
- New Indications: Existing registered devices expanding to new medical uses.
- New Manufacturers: Full analogs or generics of already registered devices.
Any product used for diagnostics, treatment, and rehabilitation. This includes high-tech equipment and daily medical consumables.
- All Medical Devices must be registered with the Belarus MOH. Foreign manufacturers intending to import Medical Devices in Belarus must appoint an Authorized Representative.
Belrosmed registration benefits
Our approach is based on 20 years experience working for manufacturing companies nationally - internationally in medical, veterinary, dietary supplements, fine food industries. BELROSMED specialist have experience working both with auditors and as auditors.
Quick start of registration
Ready to start today. Always holding capacity volume, while being very flexible in both terms and process of work. In touch with you 24/7.
Reliable and official
BELROSMED works in accordance with up-to-date laws, standards, thanks to access to constantly updated documents databases. You entrust us with your product, we minimize your risks in medical device registration.
BELROSMED offers expert 24/7 support for medical devices registration under the Republic of Belarus procedures.
We save your budget
BELROSMED is your one-stop solution for cost-effective and quality services! By choosing us, you can streamline your processes and save your company's budget. Our comprehensive range of registration services ensures that you receive top-notch solutions from a single, reliable provider.
Narrow specialisation
BELROSMED is an expert in medical devices, pharmaceutics, food products registration, import-export, promotion and distribution with 25 years of practical experience.
Fast regirstration results
BELROSMED guarantees a successful registration dossier initial expert appraisal within 15-30 days after we receive the necessary documents from the manufacturer.
Authorised Representative Service
If you are a manufacturer of medical devices looking to expand your business in Belarus, then utilising an Authorised Representative Service can be a crucial step in ensuring compliance with local regulations. Conducting, supporting, advising your medical project at all stages of registration - obtaining Registration Certificate. BELROSMED provides professional services for new registration, renewal, modification, safety, quality management of medical devices in Belarus.
Belrosmed authorised representative according to Belarusian legislation represents your interests in conformity assessment bodies, state institutions, helps to speed up the development of documents for registration dossier, registration process itself
The Belarusian government requires medical device manufacturers to have a local representative, who is responsible for handling regulatory affairs and ensuring that products meet safety and quality standards.
By partnering with an Authorised Representative Service in Belarus, manufacturers can benefit from their expertise in navigating the country's regulatory framework and market access requirements.
In addition, having a local representative can enhance communication with local authorities and customers, leading to improved customer satisfaction and business performance in the Belarusian market. Overall, the use of an Authorised Representative Service in Belarus can be a valuable asset for medical device manufacturers seeking to establish a presence in the country and ensure compliance with local regulations.
The authorised representative BELROSMED serves as a liaison between the manufacturer and the regulatory authorities, handling documentation, post-market surveillance, and communication in the local language. This partnership is instrumental in achieving compliance and successful distribution of medical devices in Belarus.
Translation & Localisation
BELROSMED professionally develops, translates, localizes technical documentation, registration dossiers for manufacturers of medical, veterinary products and equipment.