Russia Market Access
Understanding the compliance requirements for medical devices in Russia
Russia is the world’s fastest growing export market and presents many opportunities for companies seeking to expand market share. However, although the Russian Federation has made a number of significant market reforms in recent years, achieving compliance with Russia’s regulatory requirements for medical devices remains a complex process.
Russia does not currently have bilateral mutual recognition agreements with the EU or the U.S.. Further, Russia’s regulatory requirements are available only in the Russian language, and communications with the country’s Federal Service on Surveillance in Healthcare and Social Development (also known as the Roszdravnadzor) are conducted almost exclusively in Russian.
The department of the Roszdravnadzor reviews applications and decides on accepting the documents for registration. Afterwards it defines which tests (usually technical, clinical and toxicological tests) of the medical device have to be additionally performed in accredited clinical centres and test laboratories.
The last step of registration is the evaluation of the test results and the issue of the registration certificate. The certificate is valid for an indefinite period of time.
It is important to note that medical devices can only be imported into Russia by the holder of the certificate of registration. Therefore, all manufacturers based outside of Russia will need to designate a local representative.
After the registration, a Russian representative must obtain a declaration of conformity, verifying the product’s compliance with the technical requirements of the applicable GOST-R standards. The declaration of conformity has recently replaced the GOST-R certificate for most medical devices, although the underlying technical requirements remain the same. The declaration of conformity is valid for a period of up to three years.
Once a certificate of registration and a declaration of conformity have been issued, the medical device can be imported into Russia and legally placed on the market for sale.
TÜV SÜD technical professionals have first-hand knowledge of the technical and regulatory requirements for entry into the Russian market, as well as extensive experience in achieving approval of medical devices for sale in Russia.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Quality management systems certification - TÜV SÜD Product Service is an accredited conformity assessment body (CAB) for ISO 13485, and can audit and certify quality management systems.
- Other testing and certification services - TÜV SÜD Product Service can provide compliance testing for medical devices for other relevant regulations and standards, including electromagnetic compatibility (EMC).
Russia does not currently have bilateral mutual recognition agreements with the EU or the U.S.. Further, Russia’s regulatory requirements are available only in the Russian language, and communications with the country’s Federal Service on Surveillance in Healthcare and Social Development (also known as the Roszdravnadzor) are conducted almost exclusively in Russian.
The department of the Roszdravnadzor reviews applications and decides on accepting the documents for registration. Afterwards it defines which tests (usually technical, clinical and toxicological tests) of the medical device have to be additionally performed in accredited clinical centres and test laboratories.
The last step of registration is the evaluation of the test results and the issue of the registration certificate. The certificate is valid for an indefinite period of time.
It is important to note that medical devices can only be imported into Russia by the holder of the certificate of registration. Therefore, all manufacturers based outside of Russia will need to designate a local representative.
After the registration, a Russian representative must obtain a declaration of conformity, verifying the product’s compliance with the technical requirements of the applicable GOST-R standards. The declaration of conformity has recently replaced the GOST-R certificate for most medical devices, although the underlying technical requirements remain the same. The declaration of conformity is valid for a period of up to three years.
Once a certificate of registration and a declaration of conformity have been issued, the medical device can be imported into Russia and legally placed on the market for sale.
TÜV SÜD technical professionals have first-hand knowledge of the technical and regulatory requirements for entry into the Russian market, as well as extensive experience in achieving approval of medical devices for sale in Russia.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Quality management systems certification - TÜV SÜD Product Service is an accredited conformity assessment body (CAB) for ISO 13485, and can audit and certify quality management systems.
- Other testing and certification services - TÜV SÜD Product Service can provide compliance testing for medical devices for other relevant regulations and standards, including electromagnetic compatibility (EMC).
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.
Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.