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MEDICAL INSTRUMENT APPROVAL by THE MINISTRY OF HEALTH
The Ministry of Health controls the following types of products : Bottled
water, baby foods, food additives, dietary foods, genetically modified
foods, medicines, medical equipment and instruments, some other hygienic
products and cosmetics. In Russia, Medical Equipment and Instruments cannot
be imported, sold or used without GOST Certificate that is associated with Medical Approval
issued by the Ministry of Health. |
Procedure : TECHNICAL REPORT & MEDICAL REPORT
- Application with product descriptions and technical details.
- Applicant will pay tax first and attach receipt to the application
- Two test samples needed in Moscow. For high cost devices 1 sample should
be enough. First sample will undergo technical evaluation for producing Technical Expertise Report.
- Second sample will be clinically and/or laboratory tested, and the test
record will be a part of
Medical Expertise Report.
- These reports are submitted to Health Commission where evaluation meeting
will be held every
2 months with 5 specialist members from various fields. According
to the decision of the comission,
the permission given is valid for 10 years.
- Separately, GOST Certificate valid for 3 years will be issued by standard GOST scheme.
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Email  Hotline +44 (0)7827 275809 |
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Offices: UK, Moscow, St. Petersburg, Khabarovsk, Ukraine, Turkey,
Italy, Germany, USA, Japan
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