Updated: 10/24/00.

Two major government structures currently oversee regulation of medical equipment and devices: the Russian Ministry of Health and the State Committee for Standardization, Metrology and Certification (Gosstandart). The Ministry of Health works to ensure clinical safety and efficiency of drugs, and Gosstandart works to ensure product conformity with established technical and safety standards. There are basically two documents necessary for importing medical equipment into Russia: a registration certificate issued by the Ministry of Health and a certificate of conformity issued by Gosstandart.

Registration of Medical Equipment

1. Before receiving a certificate of conformity, a company should register its product with the Ministry of Health of the Russian Federation. According to Order N23, dated January 23, 1996, issued by the Russian Ministry of Health, it is prohibited to purchase and use foreign-made medical equipment in Russia without it being registered with the Ministry of Health. Upon registration, all imported medical equipment and devices are added to the National Register of medical equipment allowed for use in medical treatment in the Russian Federation.

2. In December 1998, the Ministry of Health issued an Instruction on Registration Procedure for Foreign-Made Medical Equipment and Devices, which introduced several changes into the registration process. Under the new Instruction, the registration procedure is governed and controlled by the Department of State Control over Quality, Efficiency, and Safety of Drugs and Medical Equipment of the Ministry of Health. Also, by new rules, the applicant must submit more documents than before, and most of them should be translated into Russian. This means additional expense for the manufacturer or its authorized Russian representative.

According to the Instruction, the number of tests the product must undergo is significantly increased, resulting in a longer registration procedure. Before being considered for actual registration and necessary technical and clinical trials, the product documentation must be scrutinized by the Council for New Medical Equipment within the Ministry of Health. The Council then decides whether the product should be recommended for registration. If the Council decides that foreign products have analogs in Russia, it may deny registration of the foreign product.

3. As the registration procedure includes actual tests on the equipment or device, a sample of this equipment or device should be imported into Russia for registration purposes. In order to be able to bring a device into the country the manufacturer or its authorized representative should apply to the Ministry of Health and get the appropriate permission to present at the customs point. In case of negative resolution, the equipment has to be exported back to the country of origin.

4. The registration certificate is issued in the name of the manufacturer for a term of 5 to 10 years depending on the type of device. The manufacturer or its authorized representative has the right to reregister the equipment after the expiration of the registration certificate. The cost of registration for the majority of large expensive equipment constitutes 15 percent of its price. For small devices that cost may be equal to several hundred dollars.

5. The registration procedure involves several stages such as technical, safety, toxicology, hygienic and clinical tests. Testing centers accredited by the Ministry of Health perform technical and toxicology tests. The Ministry of Health has lately been actively implementing obligatory hygienic testing and obtaining hygienic conclusions for practically all medical equipment and devices. The Department of State Sanitary and Epidemiological Surveillance of the Ministry of Health issues hygienic conclusions. Measurement devices undergo special tests to prove that they can be used as measurement means. Clinical tests are performed by healthcare institutions authorized by the Ministry of Health upon completion with positive results of respective technical and toxicology tests as well as hygienic assessment.

6. If a foreign manufacturer performs registration, it has to submit a number of documents to the Russian Ministry of Health. They include the application, technical description of the product, price information, operating instructions in Russian, copies of registration certificates in the country of origin and third countries and others. If registration is performed by an authorized Russian company, it has in addition to the above mentioned documents to submit Power of Attorney from the manufacturer notarized by the Russian Consulate office in the country of manufacture.

7. The applicant covers insurance payments for risks of adverse effects of the clinical tests on test participants. The whole procedure of obtaining a registration certificate may take from 3 to 6 months. In some cases it takes even longer to register the medical equipment depending on the character and scope of the tests.

8. Registration forms may be obtained from the Department of Testing and Registration of New Foreign Medical Equipment of the Ministry of Health. The Department also informs the applicant about the types and scope of tests for certain types of equipment, nominates testing laboratories which will perform the tests, executes control over testing laboratories and issues the registration certificates. Following is the contact information for the Department:

Mr. Aleksander Karelin, Head
Division for Organization of Testing of New
Foreign Medical Equipment
Ministry of Health of Russia
18/20 Vadkovsky Per.
Moscow 101432, Russia
Tel.: 7 (095) 973-1993/2706/1568
Fax: 7 (095) 973-2706

Certification of Medical Equipment

9. The second major document necessary for imports of medical equipment is the certificate of conformity with safety and quality requirements (GOST R certificate) issued by the Gosstandart or one of its accredited certification centers. The certificate of conformity can be obtained only for equipment which has been already registered with the Ministry of Health. Mainly customs authorities carry out enforcement of certification of imported goods. In order to clear products through customs, a certificate of conformity must be submitted for each shipment of good delivered. Imported equipment which has a GOST R certificate of conformity is VAT-exempt. It is a very important benefit as the current VAT rate is 20 percent.

10. Gosstandart and its accredited certification centers ensure product conformity through a system of end product certification. No system of GMP (Good Manufacturing Practices) so far governs production in Russia (it is trying to gradually introduce that system), and adherence to such a system is not accepted as confirmation of product conformity. Rather, manufacturers must submit finished products for testing to an accredited third party certification organization. Based on test protocols and results, a certificate of conformity may be issued on a single item or on a lot. Serial production certificates are issued for a maximum of three years, and in the case of serial production, follow-up testing is generally required.

11. Gosstandart has made significant efforts towards bringing Russian standards into compliance with international ones and has relied considerably on ISO and IEC standards in doing so. The existing system of accredited certification organizations remains in its first stages of development and, according to the American Chamber of Commerce in Russia, some companies presenting high-tech equipment for testing have experienced difficulties in finding a certification organization with sufficient technical expertise. Likewise, procedures for accepting internationally issued certificates remain underdeveloped. Only GOST R equivalent certificates obtained from foreign certification organizations accredited by Gosstandart are accepted. Certificates of conformity issued by foreign testing centers not accredited by Gosstandart are not accepted. At the same time, test protocols from foreign laboratories, test results from the manufacturer's quality control system, technical documentation from the manufacturer and other appropriate documentation may serve to reduce the amount of testing necessary for certification.

12. The applicant initiates the certification process by submitting a declaration-application to the certification organization of its choice. The certification scheme is generally chosen in conjuction with the certification organization which must approve the selection. The samples for tests are randomly selected by a representative of the applicant company along with a representative of the certification center. In order to bring test samples through customs, the certification center issues a letter of exemption from customs requirements which is granted on a temporary basis according to the terms of the testing agreement. The cost of testing varies depending on the complexity of products to be tested. Testing fees may also differ among various accredited laboratories and testing centers.

13. In conjunction with the certificate of conformity, the applicant will receive a license to use Gosstandart's mark of conformity. The mark must be placed on each imported product in order to confirm it was properly certified.

14. A list of the authorized testing centers which issue the certificates of safety and quality for medical equipment can be obtained from:

Ms. Galina Minyailik, Chief Expert on Medical Equipment Certification
Expert on Accreditation of Testing Laboratories
Gosstandart (Russian Standards Committee)
9 Leninsky Prospekt
117049 Moscow, Russia
Tel.: 7 (095) 236-3177
Fax: 7 (095) 236-6231

15. As registration and certification procedures involve direct personal contact with respective Russian government entities as well as substantial time and paperwork, U.S. companies are recommended to effectuate both procedures either through an accredited representative office in Russia or through a hired Russian or foreign agent or distributor.

16. The U.S.& Foreign Commercial Service Moscow offers assistance to U.S. companies interested in expanding their sales to the Russian market or developing contacts, including identifying distributors and arranging meetings with prospective buyers during business visits to Russia. For more information on FCS Moscow services and the Russian pharmaceutical and medical equipment market, please visit the BISNIS site at: www.mac.doc.gov/bisnis or contact:

Ludmila Maksimova, Commercial Specialist
FCS Moscow
Tel: 7 (095) 737-5037
Fax: 7 (095) 737-5033
E-mail: ludmila.maksimova@mail.doc.gov