In Vitro Diagnostic (IDV) Device registration in Belarus

IDV registration extensive experience
Belrosmed prides itself on its extensive experience in the field of in vitro diagnostic (IVD) device/product registration, which includes a wide range of products such as analysers, reagents and controls. We understand that the IVD field is complex and highly regulated, requiring a deep commitment to quality and compliance at every stage of development. Our team of experts are well versed in the intricate regulatory paths that IVD devices must navigate, whether they are new products entering the market or modifications to existing ones. Belrosmed knowledge covers not only the technical aspects of device registration, but also the nuances of regulatory requirements in different regions, including FDA in the US, CE marking in Europe, certification in Belarus, Russia and other countries.

Providing personalised advise
This allows us to provide personalised advice to ensure successful submissions and timely approvals. We work closely with our clients to develop robust documentation and risk management strategies, ensuring that all aspects of devices meet stringent safety and performance standards.
Commitment to excellence
Belrosmed commitment to excellence and deep understanding of the regulatory environment makes us a trusted partner for companies looking to bring their innovative IVD technologies to market, ultimately driving advances in patient care and diagnostics. With our expertise, we help pave the way for effective and safe healthcare solutions around the world.

Contact us today and experience the unparalleled quality of our in vitro diagnostic (IVD) device registration service. Phone: +375 29 2107277

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 IDV registration
BELROSMED offers expert 24/7 support for IDV products / devices such as analysers, reagents and controls. 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 registration of medical devices, pharmaceuticals, biopharmaceuticals, IDV products and devices, food products with 25 years of practical experience.
Fast registration 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.