- 1- Вы задавались вопросами:
- 21. «Можно ли, внести изменения в РУ 2006 г.?»
- 22. «Требуется ли, переоформление РУ при смене организационной формы?»
- 23. «Как присвоить вид медицинского изделия в соответствии с Приказом № 4н от 06.06.2012 г.?
Preparation of the registration dossier is one of the most demanding stages of the procedure related to registration of medical products. The final result, whether it's obtainment of MA or denial of registration, depends on skills of the specialist preparing the package of documents for primary submittal to Roszdravnadzor.
For preparation of the registration dossier upon request of the registering authority, at first, it's necessary to fill in the application form for registration correctly as the data from it will be copied into MA and no mistakes here are allowed. The information from each section of the application form should be confirmed by one of the documents comprising the registration dossier.
Before filling in the registration application form, the medical product should be grouped according to Type, risk class, OKPD-2 code, it's also necessary to specify its composition and accessories and its functionality and areas of application.
The application should contain information about the developer and the manufacturer of the medical product, location of production site and information of the legal entity the MA will be granted to.
As a result, you have a package of documents for the state registration of medical product, but are you sure it complies with the requirements of the regulations approved by the Decree of the Government of Russia No. 1416 dated 12/27/2012?!
By vitrue of many years of experience, our experts align themselves with rules of preparation of documents for registration, are adapted to all changes in the legislation and are ready to analyse your registration dossier, find data errors in documents, correct technical specifications of the medical product.
The cost of the service amounts to ₽90,000, the period of preparation is 7 business days.
The Registration Dossier which will be provided for check to our experts should comprise:
1. Application for registration of the medical product
2. Documents on availability of production site
3. Certificates for materials the product is made of
4. Technical and operational documentation
5. Information about regulatory documents, in accordance with which the medical product was designed
6. Photo of the product (general view, packed, on the side of label placement)
7. Information about risks the medical product pose to humans, as well as information related to clinical evaluation and validation
8. Reports of toxicological, technical tests and the report of clinical trials (for the 1st risk class medical products only)
9. Information about payment of the state duty
The prepared package of documents shall be submitted to our experts on an electronic data carrier. As a result of work, the conclusion report is prepared and recommendations of corrective actions are given.
We Hasten to Inform!
If there is no person competent in this area in your enterprise, we can train a medical product registration specialist, for you (link to the Training of Registration Specialists page) who will gain skills of independent execution of the registration dossier, will learn to organise the required tests and how to pass the registration procedure without involving third parties.
If you are interested in this proposal, please click the above link and find out the details on this service.