Preparation of documents for medical device registration is the main part of our work that is important for medical device registration.
Medical device registration is a confirmation that it meets quality and safety standards. Registration dossier is the only source of information about the medical device, so there is sense preparing it with due care. In 80% of cases, the reason for RZN refusal of registration is errors in documentation.
Registration dossier must be complete and unambiguous. While Roszdravnadzor gives 30 days to submit any missing documents and 50 days to eliminate the faults, it is better not to waste the time.
Registration dossier preparation
The content of the registration dossier was established by Decision No.1416 of the Government of the Russian Federation. The dossier must include a detailed description of the medical device: what materials were used for its production, its functions, completeness, users instructions, possible dangers. If the results are different from what is written in the registration dossier, the medical device will not be registered.
The content of the registration dossier was established by Decision No.1416 of the Government of the Russian Federation. The dossier must include a detailed description of the medical device, its operating principle, areas of application, rules for handling and potential risks. A registration dossier for any product includes:
- Technical documentation
- Operational documentation (user’s manual or instruction for use)
- Risk management file
- Information about regulatory documents
Depending on the device, other documents may be required. For example, for sterile syringes, it is necessary to describe the process of sterilization and for a laboratory analyzer, it is obligatory to provide information about electromagnetic compatibility.
We will tell you what documents are required for registering your medical device and we may prepare all the documents for you, but you should provide all the necessary information. We do not know how you sterilize suture filaments – using ethylene oxide or radiation; we will not be able to describe parameters of a mass spectrometer that you are planning to buy abroad.
Risk management file
RMF is risk assessment of a medical device at each level of its life cycle. We describe what dangers may occur, how to avoid them and eliminate consequences. We also describe the methods of identifying risks, side effects and how to manage them. Risk management is an essential part of quality management and it is required for medical device registration.
Information about regulatory documents
A summary of all regulations to which your medical device complies. It is necessary to specify risk class, OKPD2 code (All-Russian classifier of products by type of economic activity) and the type according to the Nomenclature Classifier. We also mention all regulatory documents such as GOSTs (national state standards), technical specifications etc. There are no strict rules for preparing these documents and this poses a problem – as there are no rules, authorities may find the most unexpected faults.
Often documents that are not directly related to a medical device are required. For example, a notice of trademark registration or import permit. These documents are not mentioned in Decision No.1416 but they are required for the registration
Complete information about how the device is manufactured, stored, transported and handled. We describe its operating principle, the area of application, and what is going on at each level of its life cycle. Finally, we provide a list of regulatory documents that are used for manufacturing the product and the results of qualification tests.
For in vitro devices, it is required to describe control methods and equipment, and control materials used during the tests must be attached! If the tests were incorrect, then the results of qualification tests and laboratory expertise will be different and Roszdravnadzor will consider this as a fault!
This is the document for end users. It may be a user’s manual or instruction for use. The document should be informative and unambiguous. We describe in detail how the device works, how to apply it and handle it at each stage of its use. If the device is disassembled, we instruct how to assemble it.
If there are expendable materials, we recommend what is compatible with them. We also advise on storage conditions and the use of the medical device. We provide information about possible side effects and the way to avoid them.
How much time is needed to develop the documentation?
Under the rules, we develop the documentation within 3 months. Depending on the amount and complexity of the documentation, it may take less time. However, your feedback is a critical factor. The sooner our expert receives all the necessary information, the faster the registration dossier is complete.
Cooperating with MedRegExpert, you save your time for registration – we have been working with RZN for a long time and we know how to avoid mistakes. We are aware of what questions the authority may have and how to avoid them. We also have an e-archive, it means that the documentation for the device registered in MedRegExpert will be available at any time.