REGISTRATION MEDICAL PRODUCTION

Legal counselling, Quality - certification

Description

A registration certificate is a document that allows you to legally convert a medical device (hereinafter referred to as a medical device, MI) on the territory of the Russian Federation. A registration certificate is issued on the basis of an Order of the registering authority (Federal Service for Supervision in the Field of Healthcare/Roszdravnadzor) after passing all the mandatory stages of state registration, during which the registration dossier is formed

  • Quality - certification
  • CHC, Certificate of Health Compliance
  • international guarantee certification
  • quality certification consultants

Product characteristics

Formation of a complete dossier for submission to Roszdravnadzor
yes
Control over the status of the dossier in Roszdravnadzor
yes
Filling out an application for a registration certificate
yes
Selection of laboratories for testing
yes
Preparation of a set of documents for laboratories
yes
Control of testing Development of a clinical trial certificate Obtaining a registration certificate
yes
Delivery of the registration certificate by courier
yes
Preparation of technical documentation: Preparation of technical specifications (technical file)
yes
Preparation of the operating manual Preparation of information on regulatory documentation
yes
Preparation of the act of the clinic protocol program
yes
Support before receiving the registration of a medical device
yes

Domain icon Service Provider

121616 Moscow - Russia

Contact

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