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Registration of medical equipment, instruments, and materials in Roszdravnadzor (Registration in Minzdrav)

医疗设备、仪器、材料Roszdravnadzor注册证书（注册在Minzdrav ）

俄联邦居民健康与社会发展监督部（Roszdravnadzor）Federal service on surveillance in healthcare and social development of Russian Federation (Roszdravnadzor)http://www.roszdravnadzor.ru/负责俄罗斯联邦的医疗设备，工具和材料（ Roszdravnadzor ）登记签发证书。使用任何医疗产品在俄罗斯，如果没有Roszdravnadzor登记，是禁止的。注册登记在俄罗斯有一套规定的测试和评估流程，这证实了该产品的质量，效率和安全的。注册登记证书的有效期限，登记证不限有效时间。

我们俄罗斯专家可以帮助提供医疗产品在Roszdravnadzor的注册申请，包括处理和文件编写，测试和发放登记证。我们的经理将代表您的公司来处理这些工作，这将节省您所有的烦恼和很多的时间。

这是制造商所提供的医疗产品，注册登记程序开始时需要提供的文件。这些文件是：

Cover Letter (Does not require any certifying).

The Power of Attorney to Russian Company responsible for registration. (With notary certification and apostille).

Evidence of manufacturer's official registration, i.e. Certificate of Incorporation, Establishment Registration Database etc.. (Duly certified by local Chamber of Commerce and apostilled).

Certificate of quality management system (ISO:13485). (With notary certification and apostille).

CE Certificate, Free Sales Certificate or smth. of the kind. (With notary certification and apostille).

Declaration of conformity (With notary certification and apostille).

Leaflets (min. 3 sets).

Information about medical product or medical device to be registered (Test Reports, Technical File, Used Materials List. etc.).

Instructions/manuals.

AODE will provide the following:

Notary translations of all required documents.
Filling of the application form.
Information sheet.
Normative document.
Manual and instruction.
Testing protocols (toxicology, biocompatibility, technical and clinical testing etc.).
Submission of the documents to Roszdravnadzor.
Pick up of the registration certificate

Typical time required for registration of a medical product is 2 months.