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Document list for state registration of medical devices in Russia

Document list for medical devices state registration in the Russian Federation is provided below.

•           A power of attorney for the Russian company engaged in the registration of the medical products (requires notarization and apostille).

•           The certificate of registration of the foreign manufacturer of health care products (requires certification by the local Chamber of Commerce and apostille).

•           Certificate ISO: 13485 (requires notarization and apostille).

•           Certificate ISO: 9001 (requires notarization and apostille).

•           CE certificate or сertificate of free trade, or others (requires notarization and apostille).

•           The Declaration of Conformity (requires notarization and apostille).

•           Technical file (requires a notarized translation)

On the title page indicate: For registration in the Russian Federation

Title, Signature, company stamp

•           The risk control\Risk analysis\ Management risk. (Requires notarization. Notarized translation)

On the title page indicate: For registration in the Russian Federation

Title, Signature, company stamp.

•                The report of clinical tests. (Requires notarization. Notarized translation)

•           Reviews: scientific articles (links on the Internet), a list of clinics in which the product is used, and any documents on medicine.

•           Application Manual (Requires notarization. Notarized translation)

On the title page indicate: For registration in the Russian Federation

Title, Signature, company stamp.

•           Product photos 18x24 (colored in pack and without pack) + photo of nameplate

•                Information about the expiry dates of the products inside and out. Lot number, LOT. (for permission to import samples)

•                Technical test reports, Test report of Electrical compatability and Electromagnetic compatability (signature, stamp, notarization)

•                Toxicological tests (signature, stamp, notarization)

•                Software Validation and Verification Reports - if applicable (signature, stamp, notarization)

•                Sterilization validation protocol - if applicable (signature, stamp, notarization)

•                Stability report - if applicable (signature, stamp, notarization)

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