Development of documentation for medical devices is the central part of our work and the main process of preparation for registration of medical products and devices (MDs). Registering an MD means confirming its compliance with quality and safety requirements. The registration docket is the only source of information about the medical device, so it should receive maximum attention. Documentation errors account for 80% of lack of approval by Roszdravnadzor in respect of medical equipment and any other products.

The registration docket should be full and unambiguous. Of course, Roszdravnadzor provides 30 days to send the missing documents and 50 days for remedial actions, but it is better not to waste time at all.

Making of the registration docket

The contents of the registration docket are set out by the Government Regulation No. 1416. The docket should describe the product in details: how it was made and what materials were used, how it functions, what configuration it comes in, how it is handled and what dangers may arise in the process. If the test results do not comply with the registration docket information, the device will not be registered.

The contents of the registration docket are set out by the Government Regulation No. 1416. This should be a detailed description of the device, its operation, application, handling rules, and possible risks of use. The registration docket for any device shall include:

• Technical documentation
• Operational documentation (user’s manual or instructions for use)
• Risk management file
• Information about regulatory documentation

Availability of other documents depends on the specific device. For sterile syringes, one would have to describe the sterilization process, and for a laboratory analyzer, you will need to describe electromagnetic compatibility.

We’ll tell you which documents your device might need and develop them if necessary. But the speed of our work will directly depend on the speed of providing information. We cannot determine by ourselves whether you sterilize retention sutures with ethylene oxide or radiation, and cannot describe the parameters of the mass spectrometer, which you are about to deliver from abroad.

Risk management file

RMF means assessment of the risks of using a medical device at each stage of its life cycle. We describe what dangers may arise, how to avoid them and how to eliminate the consequences. We cover methods for identifying risks, side effects, and how to deal with them. Risk management is a very important part of quality management and is mandatory for medical device registration.

Information about regulatory documentation

We give you a brief summary of all the regulations that the device complies with. We specify risk class, OKPD2 code and type according to the Nomenclature Classifier. We quote normative documents: GOSTs (All-Union State Standards), specifications and etc. There are no strict requirements towards the form and contents, which poses a problem. Due to the fact that there is no certainty, the document may face the most unexpected comments.

Technical documentation

Everything about how the product is made, transported, stored, and maintained. We describe the principles of operation and application, and what happens at each stage of the life cycle. To round it up, we specify a list of standards under which the product is produced, and the results of qualification tests.

In vitro devices require mandatory specification of the control methods and necessary equipment, and test materials are included for tests! If tested incorrectly, the results of qualification tests and laboratory examination will diverge and Roszdravnadzor will send an admonition!

Operational documentation

This document for the end user is either a user’s manual or instructions for use. It should be informative and unambiguous. We cover everything on the operation and use of the medical device, how to prepare it for use, and how to handle it at each stage of its use. If the device is stored in disassembled state, we instruct on how to assemble it.

If there are consumables, we specify compatible ones. We recommend conditions for storage and use of the medical device and inform about possible side effects and methods of their elimination.