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1
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Copies of a legal entity or sole proprietor registration documents:
- Certificates of state registration of legal entities
- Certificates of registration with a tax authority of a legal entity or a sole proprietor (or the corresponding entry sheets in the Unified State Register of Legal Entities or Sole Proprietors)
- Extracts from the Unified State Register of Legal Entities or Sole Proprietors
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2
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Technical File
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3
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18х24 photos (in color in package and not, with all accessories)
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4
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A power of attorney for the representative of the manufacturer of the medical product (Russian company engaged in the registration of medical products)
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5
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Instructions for use the medical product
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6
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Risk Management File
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7
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Qualification Test Certificate
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8
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Information on the use of similar medical products in the Russian Federation (web links, brochures, etc.)
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9
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Technical and Toxicological Test Records
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10
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Software Validation and Verification Protocols (if necessary)
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11
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Sterilization Validation Protocol (if necessary)
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12
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Stability Report (if necessary)
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13
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ISO 13485 Certificate (if necessary)
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