General Description

According to Russian law, all medical devices should be registered by Russian regulatory authorities before being imported, sold and used in the territory of the Russian Federation.

Regulatory approval procedure for medical devices:

1. Sanitary-Epidemiological Conclusion (Hygienic Certificate)
   If medical device contact skin/body or possibly harmful to patient or user, applicant must pass Sanitary and Epidemiological expertise hold by Rospotrebnadzor (Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection)
2. Registration certificate
   Submit documents for registration by Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development)
3. GOST - Certificate
   Submit documents for GOST-certification by Gosstandart (Federal Agency on Technical Regulating and Metrology)

1. Hygienic Certificate

The Sanitary-Epidemiological Conclusion Certificate or Hygienic Certificate confirms that products, activities or technical conditions conform to applicable hygienic standards and sanitary regulations in Russia.

Hygienic Certification is required for the following:

• Food Stuff - Foodstuff and beverages, food additives, biologically active additives, preservatives;
• Food or Skin – Related Products - Materials and equipment that are in direct contact with food or skin or whose vapors can be inhaled, i.e. cosmetics, textiles, toys, food processing machinery, water treatment units, packaging materials, furniture, detergents and certain household appliances, chemical and petrochemical products for industrial application;
• Kids Products - All kinds of products intended for children, including games, training appliances, stationery, baby carriages, satchels, artificial polymeric and synthetic materials used to manufacture products for children

Approval Procedure

Sanitary-Epidemiological Conclusion Certificates are issued by the Russian Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection (Rospotrebnadzor). Two independent organizations, both part of Rospotrebnadzor, are involved in Hygienic Certification:

• Center of Hygiene and Epidemiology
  Test protocol analysis and other documentation
• Territorial Office of Rospotrebnadzor
  s Issues final certificate based on the expert conclusion drawn by the Center of Hygiene and Epidemiology provided that the product conforms the compliance of the goods to the Russian Hygienic Standard.

Certificate Validity

A Sanitary-Epidemiological Conclusion Certificate is valid for 1 or 5 years depending on:

• Type of product and associated risks to human health;
• Shelf life;
• Validity of previous hygienic certificates if there are any.

List of documents for sanitary-epidemiological examination of imported devices

• Manufacturing license
• Certificates (ISO, for instance), license, or other documents of the country of origin, confirming the product safety
• Product test report
• Product sample
• Technical description of the product with the conditions of usage
• Contract for the product supply

* list of documents may vary depending on product type

2. Approval by Roszdravnadzor

Classification of medical devices

GOST-R 51609-2000 provides rules to classify medical devices. For medical purposes all medical devices are classified in accordance with degree of potential risk of using four classes. Classes are designated as 1, 2a, 2b and 3. Degree of potential risk of using medical devices increases respectively listing of classes. Each medical device belongs only to one class.

Class 1 – medical devices with low degree of risk (some noninvasive electrodes, a number of surgical devices, some types of medical devices and etc.);
Class 2а - medical devices with average degree of risk (diagnostic ultrasonic equipment, some dressing, some blood reagents, apparatus for physical therapy and etc.);
Class 2b - medical devices with heightened degree of risk (apparatus for anesthesia, apparatus for administration and etc.);
Class 3 - medical devices with high degree of risk (implanted pacemaker, artificial heart valves, apparatus for hemodialysis and etc.).

*Sets of reagents may be referred to classes 2а, 2b or 3 depending on potential risk of results of their using.

Approval procedure by Roszdravnadzor

1. The first step for a company that would like to sell a medical device in Russia is to identify an equivalent device which has been registered already in the Russian Federation, and to provide documentation certifying equivalence with this predicate. (N.B. In the Russian Federation, this is called an ‘analogue’ device).
   Order No 735 notes that there are two ways to register products in the Russian Federation:
   
   Type 1:
   Class 1 and 2a devices with a clearly identified equivalent device already registered in the Russian Federation (same classification, applied in the same manner, same efficiency characteristics) must demonstrate that the product is essentially similar to the predicate. This can be accomplished by preparing a document that demonstrates the lack of differences or by submitting technical testing/safety evaluation certificates comparing the new device to the predicate.
   
   Type 2:
   Class 1 and 2a products without an equivalent device and all Class 2b and 3 devices must be tested for product quality, efficiency and safety. These tests are specified by Roszdravnadzor and must be conducted by government-appointed testing centres. Tests conducted outside the Russian Federation, regardless of how similar, are not accepted.
2. Confirm classification of device using GOST-R 51609-2000
3. Appoint authorized representative in Russia to coordinate device registration
4. Apply to Roszdravnadzor for permission to import testing samples
5. If device contact skin/body or possibly harmful to patient or user, applicant should have SANITARYEPIDEMIOLOGICAL (HYGIENIC CERTIFICATE) testing completed at authorized labs within Russia
6. Prepare registration dossier which includes testing results and submit to Roszdravnadzor
7. Roszdravnadzor reviews Registration Dossier and accepts or rejects (Additional testing may be required by Rozdravnadzor after review of Registration Dossier)
8. If approved, Roszdravnadzor issues registration certificate (Certificate does not expire unless changes made to device, claims, packaging, etc.)
9. Approved devices listed on Roszdravnadzor website

List of documents for registration:

1. Application form for registration
2. Document confirming the tax payment
3. Short reference about the device
4. Documents confirming juridical registration of the manufacture
5. Documents (national on international) confirming the compliance of the conditions of production and the device itself to the international norms and standards. ISO 13485, ISO 9001, Declaration of conformity to the Directive 93|42|EEC, Certificate of Marketability or other analogues documents
6. Normative documents confirming the conformity of medical products to its requirements or technical requirements or standards
7. Instruction manual
   *All documents for the registration of medical devices must be submitted in Russian language or have a certified translation into Russian

3. GOST-certificate

The Russian GOST certificate can be described as a combination quality and product safety certificate. It's required because imported products must conform to Russian standards which are not harmonized with European or International standards. Therefore CE self-declaration cannot replace the Russian Certificate of Conformity. However, if you already have an ISO certified quality system, it will be easier for us to help you coordinate GOST-R certification for your company / medical device.

The list of the documents, required for GOST-certification of medical devices

The applicant should submit the following documents to the Federal Agency on Technical Regulating and Metrology:

• A guaranty letter (a letter from an applicant proving his intent to certify a product/products on a company letterhead) with payment details, sighed by a director and a chief accountant, sealed by an applicant.
• The application for certification of medical devices (in GOST R certification system).
• A copy of a certificate of registration in the Federal Service for Surveillance in the Sphere of Healthcare and Social Development (Roszdravnadzor).
• A copy of a contract for the supply of medical devices (if an applicant is a seller/trader).
• An organization brochure (preferably in Russian language).
• Instructions for use (preferably in Russian language).
• A copy of expert sanitary-epidemiological approvals, also known as hygienic conclusions or sanitary certificates (for medical devices that enter into contact with patients).
• A copy of pattern approval certificate of measuring instruments.
• If an applicant is an authorized representative of a manufacturer he should show a document, that gives him official permission to conduct certification process.
• All copies should be attested by an applicant.
• Also you should fill in The application for certification of products. If your medical product is supplied with the accessories you should fill in The annex to the application for certification of products.