The Engineering Center Medical Devices and Technics provides consulting services in the area of registration of medical devices and medical equipment. The price of services depends on the terms of implementation. It also is made up of combination of factors such as the amount of documentation that needs revision and the complexity of the registered product. Tests are performed only in accredited labs.
For Russian producers, the following are the documents required. Applicant's documents such as INN, PSRN, present extract from the Unified State Register of Legal Entities, a notarized power of attorney for the best to behave in the interests of the applicant are needed. Manufacturer files for verifying the place of production and act of eligibility (approval ) evaluations (if any). Technical documents like QMS certificate of conformity (ISO) (if any), technical requirements (TU), and instruction or operation guide (if any). It also requires a description and photo description of the product being enrolled and photos of the product that is registered.
Registration of honey merchandise is compulsory because one of the responsibilities of the supervisory authorities of the member states is to track the quality and security of medical goods sold in the ИЦМИИТ marketplace. Only those products that have passed mandatory registration can be put into circulation. It isn't simple to independently understand all of the intricacies of the current laws, even for seasoned experts.
When Assessing medical apparatus, the conditions of usage and operational purpose are taken into account. The next criteria include the whole period of usage of medical devices, the invasiveness of health devices, the presence of contact of medical devices together with the human body, or even the relationship with it. Additionally, it contains the way of introducing medical devices into the human body through bodily cavities or surgically and the medical device for vital organs and organs like heart, central circulatory system, central nervous system, and energy resources.