State registration of medical devices

Medical products that enter the market must go through the state registration procedure. Both fulfilling the requirements of the Law on the Procedure for Registration of Medical Devices and the certificate increase consumer confidence and protect goods from counterfeiting. Since 1999 state registration of medical devices has guaranteed that the product meets the quality and safety standards established in the Russian Federation.

The entry of medical goods in the register in Russia is mandatory - without a certificate, the product will not be allowed on the market. The procedure for obtaining a permit itself consists of several stages and must comply with the documentation standards in accordance with the Order of the Ministry of Health No. 303. It can take 3 to 12 months and will require your ongoing monitoring. If you are unable to obtain permission yourself, entrust it to our specialists.

Registration of medical devices in Russia

Registration of medical devices in Russia takes place in accordance with the provisions of the current legislation.

The first stage is the sequential development and preparation of technical documentation for a medical device. After receiving the package of documents, it is examined for the following factors:

  • technical compliance;
  • clinical compliance;
  • toxicological compliance.

Registration and certification of medical devices

Registration and certification of medical devices is a complex process that includes several stages, Sigma Lab specialists are ready to advise you on all the nuances of each stage.

According to the law of the Russian Federation, the production must have a quality management system according to the ISO 13485 standard. SigmaLab specialists are ready to advise you on the procedure for documenting medical devices and help in the collection, preparation and development of technical documentation.

Services:

  • preparation of a registration plan;
  • preliminary tests of medical devices in laboratories with accreditation;
  • development of regulatory documents and registration dossier;
  • development of documents for the quality management system, etc.

 

Order state registration of medical devices in SigmaLab

By contacting our company, you will reduce the time for preparing registration documents and be sure that they comply with the law. You just have to submit a package of documents for verification to the regulatory authorities.

 

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