registration certificate from Roszdravnadzor for ophthalmic equipment

Medical equipment is subject to mandatory declaration on the basis of PP RF No. 2425. In addition, it is required to obtain a registration certificate from Roszdravnadzor (RU).

Certificate of conformity for ophthalmic equipment can be obtained additionally (voluntarily) according to GOST R or ISO standards, after completing the mandatory quality assessment.

Why do you need a Roszdravnadzor registration certificate and a GOST declaration?

Before declaring, it is necessary to obtain a registration certificate. The document confirms the registration of the device in the register and gives the right to use the equipment in doctor's offices, medical institutions, sanatoriums, rehabilitation centres.

Declaration of medical equipment is provided for entrepreneurs who are engaged in the production, import and sale of such products in the Russian Federation. Without a declaration, the activity is illegal.

Government Decree
Declaration is carried out in accordance with the requirements of the Resolution of the Government of the Russian Federation №2425 from 23 December 2021. The issued authorisation document is valid throughout the whole territory of Russia.

Voluntary certification
Voluntary quality assessment will help to strengthen the image and increase sales. Often a certificate for equipment is required to conclude a large contract or participate in a tender.

It is possible, for example, to obtain a certificate according to ISO 9001 standard - this will significantly increase the loyalty of consumers and customers to the brand. It is issued in our system "Promtehsertificatsiya".

Terms and prices
RU is issued for quite a long time - from 3 months, and costs from 120 thousand rubles. We recommend carrying out the check well in advance.

Voluntary certificate can be obtained in 1 working day, the cost - from 10 thousand rubles. The minimum cost and speed of registration are possible due to the presence of our own accredited body.

海关联盟EAC认证中心/上海经合工业设备检测有限公司

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