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Certification of medical products

Medical devices are the products and appliances used in medical practice for the diagnosis, prevention and treatment of diseases, as well as patient care.

Today certification of medical products is a procedure that is performed to determine if the characteristics of the medical device meet the standards and norms by the established legislation. As a result of this procedure, a certificate is issued.

The medical devices are intended for mandatory certification procedures in accordance with the EEA Technical regulations of the Customs Union, as these products have a direct impact on human health and life.

The required declaration for medical products is issued in accordance with the Customs Union technical standards. It is issued on a standard yellow form, approved by the Government of the Russian Federation.

Also almost for all types of medical devices it is necessary to issue a registration certificate issued by the Ministry of Health. This document is a confirmation of product’s compliance with safety and ecological compatibility. This certificate is issued for such items as:

  • biologically active additives and raw materials which are necessary for its production,
  • specialized and baby food,
  • hygienic and cosmetic products,
  • Medical Technology,
  • Pharmaceutical products,
  • Veterinary products, etc.

More information about certification of medical products in Russia

With certification of medical devices, a classification of products specifically taken into risk groups will establish the criteria for evaluation of its quality. Sample list of risk groups is defined in the appendix of Gosstandart 51609-2000. Detailed advice on this matter can be obtained from the CA in Novosibirsk.

To get a certificate for medical devices you can apply to the certification authority which has a state accreditation. For this purpose, the data center must submit an application form, copies of the charter documents of the organization, the documents describing the characteristics of the product and the process of production (the full list is available from specialist center) and samples for research. After that, the specialists of certification laboratory make tests of the samples, after which the Certification Commission decides to issue the supporting documents. If the characteristics of the product cavity meet the appropriate legislative burrows, the applicant gets the certificate. If there are differences, the CA may reject the issuance of this document.

For the certification of virtually all types of health care products you can contact the certification center in Novosibirsk. Our experts will be happy to assist you on this matter.

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