Approval of Medical Devices in Russia

Understanding the compliance requirements for medical devices in Russia

Russia regulatory improvements presents many opportunities for companies seeking to expand market share. However, although the Russian Federation has made a number of regulatory improvements in recent years, achieving compliance with Russia’s regulatory requirements for medical devices remains a complex process.

Compliance challenges

Russia does not currently have bilateral mutual recognition agreements with the EU or the U.S.. Further the necessary tests should be performed in Russia. Russia’s regulatory requirements are available only in the Russian language. Submission of registration documentation and communications with the country’s responsible authority Federal Service for Surveillance in Healthcare (also known as the Roszdravnadzor) are conducted also almost exclusively in Russian. Moreover, it is important to know that all manufacturers based outside of Russia will need to designate a local representative.

Regulatory process

Prior to submission of the technical file to the authority, the applicant should perform different technical (mechanical, electrical, EMV) and toxicological (biocompatibility) tests according to the applicable GOST—R standards in Russian test laboratories. The compiled technical file should be submitted to the authority, which in turn delegates the expertise of technical documents and test results to a safety experts' organisation. Based on the review result of the safety experts' organisation, the extent of clinical evaluation is defined.

The last step of registration is the evaluation of the clinical test results and the issue of the registration certificate. The certificate is valid for an indefinite period of time.

After the registration, a local 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. 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.

Why choose TÜV SÜD

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.

Our services at a glance

• 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 Centre of Excellence, 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.