Methodology for determining the amount of fees for the provision of services for the assessment of production conditions
Recall that in the process of registration of medical devices according to the rules of the EAEU, inspection of production is provided. You can familiarize yourself with the draft document on determining the amount of payment for such an inspection.
A draft “On Approving the Methodology for Determining Fees for the Provision of Services for the Assessment of Production Conditions and the Quality Management System of the Manufacturer of a Medical Device (Production Inspection) for compliance with the requirements for the implementation, maintenance and evaluation of a quality management system for medical devices in depending on the potential risk of their use in order to register medical devices within the framework of the Eurasian Economic Union and the maximum the size of the fee for the provision of the specified service ”
Developer: Ministry of Health of Russia
Start date for discussion: 09/02/2019
Public discussion end date: 09/20/2019
Link to the project https://regulation.gov.ru/p/94481