- 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.?
The Declaration of conformity
As far as it's known, the activity of entities in the area of utilization of medical products should be carried out in strict compliance with the legislation of Russia. Otherwise, the illegal actions may cause to unwanted consequences like penalties and other sanctions and restrictions by the government.
The main task of the manufacturer of medical products is to posess the marketing authorisation for successful sales of the product in the market. But it still doesn't allow free and legal utilization of the registered medical product in the territory of our country. That's why there is another permit — the Declaration of conformity, which can be issued right after obtainment of the marketing authorisation.
The Declaration of conformity has a limited period of validity and is issued for 1 or 3 years
The Declaration of conformity is a permit confirming compliance of the medical product with the Russian state standards (GOSTs).
Please note!
The Declaration of conformity is not issued for all medical products. In such case, the certification agency may send a Clarification letter stating that the particular product is no subject to issuance of the declaration and certificate. Such document is also called the letter of denial. Sometimes the manufacturers also order a voluntary certificate with the letter of denial which may play an influential role in auctions and tenders.
Medical Products Requiring Declarations of Conformity
Surgical fabrics
Medical equipment
Dental materials
Medical tools
Prosthetic and orthopaedic accessories
Surgical and dental implants
Therapeutic and diagnostic units
Polymeric medical products
Instrumentation
How to Formalize the Declaration for a Medical Product
Like the certificate of conformity, the Declaration is a quite valuable document in the area of utilization of medical products. There are 2 situations defining the period and costs of issuance of this important document:
1) If you've registered your product with Roszdravnadzor and obtained the marketing authorisation, you have all the package of documentation required for issuance of the Declaration of conformity. In this case, it may be issued within just 5 business days. The cost is ₽44,000.
2) If the package of documents was prepared three years ago, the reports of tests included in this package should be renewed. In other words, the Declaration is issued quicker and cheaper without testing and if the tests are required, you'll need to spend a little more money and wait a little longer. The period of carrying out the tests is up to 14 days, the cost of tests is ₽50,000.
Our experts have been providing the permits issuance services for many years. For more detailed discussion of conditions of obtainment of the Declaration of conformity, you may contact us during working hours and find answers to all questions interesting for you.
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