- 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.?
Each manufacturer of medical products sooner or later has to decide how to register a medical product: Using own resources or using the services of skilled specialists in the area of registration of medical products.
In this article, we'll describe advantages and disadvantages of both approaches.
If you've decided to carry out all the processes of the state registration of medical products on your own, it's necessary to train a specialist in registration of medical products , who is able to conduct this procedure on his/her own from the beginning to the end. The main thing is to define what kind of production the employee will register: Either domestic or foreign as specific aspects of registration depend on it. This approach will help significantly reduce not just financial costs and time for search of the potential partner working in the area of registration of medical products but also the time required for obtainment of permits.
If having large experience in the area of registration of medical products, sometimes you may face non-standards situations for the first time. In such case, it's useful to use the consulting and informational services, which resolve different tasks arising in the area of registration of medical products. Probably, your particular situation has already happened and it's the specialists' long-term experience which will help resolve it.
If you've already happened to register medical products on your own but have doubts about correctness of the executed registration dossier, you may order a preliminary assessment of the registration dossier, after which the medical product will easily pass the relevant stages.
If you've decided to use the registration service, it's necessary to understand that there are lots of companies in this area and there is a risk of meeting a non-professional.. That's why sometimes it's complicated to make the right choice of a company, which will lead the process of obtainment of the marketing authorisation for the medical product until the required result is achieved.
Your decision should not be impulsive, it's necessary to make a wise choice of the specialist in the area of registration of medical products, as the final result depends on the company's experience and good business practice.
Sometimes the registration period is expanding while the desired results are still not achieved. Then the manufacturers of medical products start doubting: is the registration procedure being carried out in a normal course or is something wrong here?!
Sometimes such cases really happen in the area of registration of medical products. But even in such circumstances the right way can be found.
If you've paid money for a non-professional and don't know what to do in this situation, you can contact an expert , who will recommend you the right decision in any non-standard situation.
Selection of a partner is the most important stage before the start of the registration procedure. To obtain the marketing authorisation after the first submittal and within the optimal term, you'd better ensure the experts of the company you are going to contact are competent.
You can define the skill and reliability of the partner using some of the following ways:
The average market price of turnkey registration is equal to about 750–900 thousand rubles and the cost can't be less than this level
That's why if the potential partner's price is lower than the above mentioned level, it means that he hides information about additional payments which you will probably know about only after the start of the registration procedure. So be attentive and careful.
Before entering into an agreement, find out if the additional payments will be arising at any stage of the registration.
So, the procedure of registration of a medical product is a complicated process requiring much efforts. Of course, everyone of you will have to decide how to register the medical product.
You can train your employees in order to arrange and to simplify the process of issuance of permits for medical products manufactured by yourself. If you think it's not necessary, you can ask the experts in registration of MD for support.