Registration pharmaceutical products, API, dietary supplements and medical devices

01

Preliminary examenation of Dossier

Evaluation of completeness of submitted materials and their compliance with the requirements of registration authorities

Approval of application for registration with the Customer (discussion of list of accessories, options)

Coordination with the Customer of letter and the contract for importation of the product in the Russian Federation for the purpose of registration and testing

Coordination with the Customer of documents from the manufacturer, in particular:

• - power of attorney from the manufacturer
• - company registration statements from the manufacturer
• - certificates ISO 9001, 13485 (for production)
• - declaration of conformity (for products)

02

Preparatory stage to state registration

Translation of source documentation received from the manufacturer

Selection of accredited databases, conclusion of a contract with the bases (for technical and toxicological tests)

Registration of permission for import of samples for testing (for medical devices of foreign production)

Obtaining approval for the import of the product for testing

Forming of documents package for purpose of registration and organization of testing, in particular:

• - references
• - normative document (technical documentation or technical specification)
• - adjustments to the operating documentation (operating instructions, operating instructions, operating instructions)
• - check and correct (if necessary) labels
• - organization of technical tests; monitoring; verification of the report, finalization, reconciliation
• - organization of toxicological tests; monitoring; verification of the report, finalization, reconciliation
• - Preparation of documents set for preliminary verification, taking into account elimination of violations and prevention of denial of registration

Completion and completion of the dossier in accordance with regulatory requirements

Registration on the portal of Roszdravnadzor

Submission of the dossier to Roszdravnadzor

03

Accompany of the registration process Obtaining of registration sertificate

Organization of expert examination in the direction of Roszdravnadzor

Monitoring of the 1st stage of quality examination, efficiency and safety of medical devices

Submission of additional materials and information, responses to expert requests

Writing the protocol of clinical trials (if necessary)

Organization of clinical trials of medical devices, including obtaining permission for clinical trials in authorized departments and concluding a contract with accredited databases (if necessary)

Checking the report, finalizing, agreeing (if necessary)

Submission of a report to Roszdravnadzor

Monitoring of the II stage of the examination of quality, efficiency and safety of medical devices

Submission of additional materials and information, responses to expert requests

Entering a medical device into the State Register, obtaining a Registration Certificate