Technical dossier preparation-bg

Technical dossier preparation

The concept of a registration dossier, as well as its composition, is clearly described in the Decree of the Government of the Russian Federation dated 27 December 2012 No. 1416 "On Approval of the Rules for State Registration of Medical Devices". ( Order 1416)

So, what is a registration dossier?

"Registration dossier" is a set of documents submitted for state registration, amendments to such documents, as well as copies of decisions taken by the registration body in relation to a particular medical device.

In short, the main documents for registration of a medical device are:

  1. Statement for registration,
  2. Technical file,
  3. Instruction for use (or user manual),
  4. Biocompatibility trials,
  5. Technical trials,
  6. Clinical trials,
  7. Information about applied standards,
  8. Permission for samples import,
  9. Photographic images of product and its parts,
  10. A number of additional trials required depending on the type of device, such as EMC (for active MD), medical device trial for the purpose of type approval of measuring instruments.

All documents of the registration dossier shall be drawn up in Russian or translated into Russian and the translation shall be notarised.

The requirements for the content of the registration dossier are described quite clearly in the Decree of the Government of the Russian Federation No. 1416 of 27.12.2012 (as amended), but the content of the documents is regulated by many other normative acts, which complicates the procedure of preparing a set of documents for the registration dossier and requires experience, knowledge, as well as the ability to "read between" normative acts.

In conclusion, it should be noted that a correctly prepared registration dossier allows you to reduce the time required to register a medical device and avoid large requests from Roszdravnadzor.

 

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