Frequently Asked Questions about Registration of medical devices in Belarus

The cost of registration of medical devices and equipment in Belarus is a critical consideration for manufacturers looking to enter the country's healthcare market. Belarus has a strict registration process governed by the Ministry of Health, and the associated fees can impact the financial viability of bringing medical products to the country.

The registration cost varies depending on the classification of the medical device, with Class III devices incurring the highest fees. Manufacturers must also account for additional expenses such as document translation, product testing, and engaging local representatives or agencies to facilitate the registration process. These cumulative costs can significantly impact the overall investment required to bring medical devices to Belarus.

It's crucial for manufacturers to thoroughly research and understand the registration fees and associated expenses before initiating the process. By budgeting and planning accordingly, companies can ensure they are financially prepared for the registration journey.

Despite the expenses, gaining access to the Belarusian market can be financially rewarding for medical device manufacturers. The country's healthcare sector is experiencing rapid modernization, presenting lucrative opportunities for innovative medical solutions. Additionally, once a product is registered, the potential for growth and profitability in Belarus can outweigh the initial costs.

In summary, while the cost of registration for medical devices and equipment in Belarus can be considerable, it's crucial for manufacturers to view it as an investment in accessing a promising market. Understanding the expenses involved and planning strategically can help companies navigate the registration process while capitalizing on the opportunities presented by Belarus' evolving healthcare landscape.

BELROSMED experience in registration
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.

Expert support in 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.

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.

This can help streamline the approval process for medical devices and facilitate smoother market entry, ultimately allowing manufacturers to focus on their core business while meeting compliance obligations.

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.