Roszdravnadzor registration certificate

Certification of products in health care is otherwise called medical certification. This is a procedure for confirming the safety and quality of medical instruments, equipment, materials by conducting tests and evaluations.

Medical certification is the fixation of medical devices, medicines, medical equipment, as a result of which a Registration Certificate is issued. The registration certificate of the Ministry of Public Health of the Russian Federation, the Registration Certificate of Roszdravnadzor confirms that the medical device has been registered in the Russian Federation and entered into the State Register of medical devices and medical equipment.

If the product is supposed to be used on the territory of the Russian Federation and is a device or apparatus, then it must undergo mandatory state registration. The product can be both domestic and foreign. Mandatory medical certification must pass:

software used for medical purposes;
medical equipment;
medical products;
tools and materials.

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