State registration of medical products in Russian Federation

February 8, 2018

 

 

The first step to place medical products on the Russian market is to go through the State registration of medical products, that are defined as any instruments, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination, as well as together with other accessories necessary for the application of these products for their intended use.

 

State registration of medical products

 

  • Is a state procedure for conformity assessment of products to the requirements of the Russian legislation.

  • Requirements of the state registration are established in the Federal law No. 323-FЗ "On the fundamentals of protecting health of citizens in the Russian Federation".

  • Procedure for the state registration: Government Decree of the Russian Federation No. 1416.

  • Regulatory body is the Federal service for healthcare supervision (Roszdravnadzor).

 

State registration is subject to any instruments, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination.

 

State registration is not applicable to the medical products manufactured according to individual orders of patients to whom special requirements are made and which are intended solely for the personal use by a particular patient.

 

Stages of the state registration procedure

 

  • Collection and formation of primary documentation;

  • Sampling of products under registration;

  • Acceptance testing;

  • Submission of application to Roszdravnadzor authority;

  • Clinical trials;

  • Expertise of registration documentation;

  • Issuance of registration certificate.

 

Document requirements for the registration certificate

 

  • Applicant is a manufacturer or an authorized representative;

  • No time-limit for the registration certificate.

 

State registration is quite long and complex process, that medical products must go through to comply with Russian law and regulations.

 

 

Information has been prepared by the GMA Consult Group team.

 

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