Medical Equipment & Instrument Approvals by The Ministry of Health

 

General Information:

The Ministry of Health of Russia is obliged to control and give permission for these products: Bottled water, some children foods, some food additives, dietetic foods, genetically modified foods, medicines, medical equipment and instruments, some other hygienic elements and cosmetics.

In reality, the most common situation is to obtain permission and GOST Certificate for medical equipment. Because of this reason, this matter more important and effects foreign Medical Equipment producers.

In Russia, Medical Equipment and Instruments cannot be imported, sold, and used for patients without GOST R Certificate and Medical Approval by Ministry Of Health of the Russia.

To issue GOST R Certificate for Medical Equipment and Instruments, firstly permission should be obtained from the Ministry of Health.

Procedure:

1. The company should apply officially to the Ministry of Health for a certain Medical Equipment or Instrument.

2. An official tax-payment should be transferred to the Governmental Budget depending on declared price of the equipment before the application procedure.

3. 2 pieces of sample equipment should be obtained in Moscow. In some cases, when the equipment is very expensive, 1 piece is enough for different tests.

4. First sample will be evaluated technically, and "Technical Expertise Report" will be prepared.

5. The other sample will be tested medically on the patients; "Medical Expertise Report" will be prepared.

6. These reports are submitted a Health Commission (These meetings are arranged every 2 months once with 5 members from various fields) According to the decision of the commission, the permission will be issued for 10 years for the subject product.

7. Regarding to this permission, GOST R Certificate will be issued for three years serial production with the standard GOST Certification procedure. In some cases, the same Certification Body prepares Expertise Report, GOST R certificate and takes place in this Health Commission. This possibility makes easier and speeds up the whole process.