Since the Russian technical regulations came into effect on July 1, 2002, the Russian government did not directly endorse the registration of other countries. Even if it has passed the US FDA certification and the EU CE certified products, must also go through the registration process to allow entry. Of course, if the manufacturer to provide in line with international standards related to the certification documents, you can simplify or partially exempt the program, but can not be free. Such as ISO certified enterprises in China, can simplify the quality management-related checks.

As the registration process in Russia is quite complex, the registration requirements will often change as the regulatory requirements change frequently, and the simplicity of the registration process depends largely on the level of familiarity with policy and related institutions. Therefore, in Russia through medical device product registration, it is best through the following ways: the establishment of a branch in Russia, or commissioned by the Russian dealer, agency or consulting firm to operate. If necessary, it is also possible to communicate face-to-face with the relevant experts of the registration authority by the authorized representative of the applicant company.

The entire registration process includes the following steps:

(1) An authorized representative of the company shall submit the documents required for registration by an expert in the registration office of the Ministry of Health who is responsible for the registration of imported medical devices;

(2) The registrar will review the document with reference to the relevant technical standards of the Russian National Bureau of Standards and determine whether the document complies with the registration requirements;

(3) The registry will conduct a more in-depth review of the documents in the light of the relevant technical standards of the Russian National Bureau of Standards and determine the type and scope of the medical device products to be performed (eg technical performance, clinical, toxicology, etc.);

(4) The National Institute of Instruments is responsible for the relevant testing of products and the designation of medical institutions for clinical validation (Russian Medical Devices Research Institute is responsible for product testing authority, allegedly in each professional field has a responsible expert, 36 Division, according to the type of division, were responsible for the professional equipment of the technical assessment);

(5) the registration authority will be tested after the final review, if the requirements, that will be approved and issued product registration certificate.

The entire registration process is short 4 to 6 months, long 1 year, depending on the product to be accepted by the test and clinical content. Equipment such as medical equipment, such as instruments, appliances, devices and other products usually need technical maintenance, the registration certificate is valid for 10 years; medical consumables category of medical equipment, such as diagnostic reagents, disposable supplies, etc. do not need technical maintenance Product, the registration certificate is valid for 5 years.

Recently, the Russian Ministry of Health officially introduced a long-awaited registration of drug registration criteria (including medical equipment), at the same time, the official registration fee has also been raised. The proportion of the installment fee is adjusted to 80% ~ 85% of the prepaid registration, and the balance (15% ~ 20%) is paid at the time of receiving the certificate. Specific registration fee for small equipment: $ 2070; large equipment: $ 6000.

The registration fee does not include the cost of testing and clinical trials. The inspection fee is paid directly by the production unit to the Russian Ministry of Health. The cost of the clinical trial is to be paid according to the contract of the production unit and the clinical research unit. Calculate the cost of the test, the cost of the clinical trial and the commission of the advisory body, the entire registration process will become very substantial funding, the general success of the registration card will pay the cost of registration fees will be 4 to 5 times.

　The actual registration procedure and registration fee shall be borne by the production unit of the product, and the product registration certificate shall belong to the production unit. Although, in very rare cases, the Russian dealer will be responsible for the registration of the product, and bear most or all of the costs, but in such circumstances, the registration certificate belongs to the dealer all. So that if the product dealer has changed before the product registration certificate expires, it will cause trouble to the production unit and produce many uncertainties.

The product registration certificate is the first and most important document to allow the product to be operated and used in the country. However, one or two of the following documents (depending on the product category) should also be obtained for the purpose of passing the product through the customs and selling it on the Russian market:

Russian national standard certification "GOST" certificate and health and quarantine inspection certificate. GOST certification is an effective quality certification system within the Russian Federation. GOST certification for their own companies and export products to foreign companies in Russia is very important, it is equivalent to other countries ISO9000 system certification, the quality of the Russian Federation is a sign of recognition. Medical device products in Russia are mandatory certification products.

The Russian government standards bodies and other specialized accreditation centers and laboratories accredited by the Russian National Standardization Metrology Committee (GOSSTANDART) are the authorities of such certification, which determine whether they meet Russian standards by analyzing production systems and testing products. Production units provide some documents and samples to be tested in accordance with Russian quality standards. The certification body has rigorously tested the documents and samples under the strict control of GOSSTANDART. These institutions are mainly located in Moscow and have their own certification areas.

The GOST certificate is divided into a single delivery certificate, 1 year certificate and 3 year certificate. Single delivery certificate: The production unit can use this certificate for a single delivery. To apply for this certificate, the production unit does not need to provide samples, only to provide documents. If there is only one customer in Russia and only a certain number of goods is provided, it is appropriate to apply for such a certificate.

1 year certificate: Production units can export their products to Russia within one year. Need to test the product samples, and submitted to the production unit of the official documents, including company registration, trademarks, ISO9000 certificate copy, but do not need to produce site inspection.

3 years Certificate: With this certificate, the production unit can export their products to Russia for 3 consecutive years. Each year the certification body of the experts need to go to the country of origin of the product production units to conduct on-site assessment.

Rospotrebnadzor is the authority responsible for health and quarantine, which is responsible for monitoring the safety and hygiene of the inspection and quarantine of the Russian people, and the health and epidemiological security of the population of the Russian Federation. The Russian Federation has the quarantine requirements for some products. , Consumer rights and consumer market protection, and is affiliated with the Ministry of Health and Social Development of the Russian Federation (Roszdravnadzor).

The Russian Federation requires that certain goods that may be potentially harmful to human health must be quarantined when they are imported into Russia. Products that require health quarantine are products that are in direct contact with the skin, chemicals and biological products (excluding drugs) that are used for the first time to potentially present the human body, and products that have been shown to have potential risks to the human body.

If the product is inspected by the Ministry of Health before registration, the certificate is valid for 1 year; if the product after registration through the test, the certificate is valid for 5 years. As Russia is in the stage of economic transition, there are many laws and regulations are imperfect, there are many loopholes in the actual operation, and there are some "hidden rules", enterprises in the process of reporting the registration of cultural and language sometimes encounter some trouble. Therefore, in the local choice of a certain advantage of the partners or agencies to jointly develop the local market is the main way of domestic enterprises to choose.