Regfort Registration Eng

Regfort Registration Eng Protected by «Regfort» throughout the registration path.

We are often asked what is the difference between the average life and the warranty life of a medical device.Average lif...
26/01/2021

We are often asked what is the difference between the average life and the warranty life of a medical device.

Average life is the approximate life for which the product is designed to be used. While the warranty period is the period for which the manufacturer's warranty is given.

In this case, the guarantee is the period during which the quality of the goods must meet the established requirements.

The average and warranty periods of operation should be indicated only for the medical device itself; for accessories, this is not necessary, with rare exceptions.

The Regfort team is constantly improving its qualifications in order to advise clients with pinpoint accuracy. For examp...
26/01/2021

The Regfort team is constantly improving its qualifications in order to advise clients with pinpoint accuracy.



For example, recently the CEO of the company, Victoria Khokhlova, received another certificate from the Federal State Budgetary Institution VNIIIMT of Roszdravnadzor after participating in the seminar "Inspection of production of medical devices intended for circulation within the Eurasian Economic Union."

Over the past two years, more than half of the laboratories have lost their accreditation. And those laboratories that s...
26/01/2021

Over the past two years, more than half of the laboratories have lost their accreditation. And those laboratories that still have it have received a very heavy load. As a result, application processing and testing slowed down significantly.

The scammers quickly got their bearings and decided to make money on it. Doubtful organizations will assure you that they can speed up your registration and testing for a certain amount. But in reality this is impossible - the laboratories, Roszdravnadzor and customs have a single system, which, in turn, is closely monitored by the FSB.

As a rule, such scammers take an advance payment and disappear, but it is extremely difficult to find them..

Recently we received the following question: is it necessary to update the manufacturer's CE certificates in the registr...
26/01/2021

Recently we received the following question: is it necessary to update the manufacturer's CE certificates in the registration dossier due to the expiration of their validity period?

The issue is related to the fact that manufacturers of certified products are forced to periodically renew their certificates of conformity. This also applies to importers.

The answer can be found in the Decree of the Government of the Russian Federation No. 1416 of December 27, 2012:

"37. Changes made to the documents contained in the registration dossier that do not require an examination of the quality, effectiveness and safety of a medical device include:

e) change by the manufacturer (manufacturer) of the medical device of the validity period of the documents contained in the registration dossier. "

As we can see, after renewing the certificates, it is necessary to immediately update the information about them in the registration dossier.

Good news from the Regfort Guardians!According to Decision No. 46 of the Council of the Eurasian Economic Commission dat...
26/01/2021

Good news from the Regfort Guardians!
According to Decision No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016:
"In the transition period until December 31, 2021: registration of a medical device at the choice of the manufacturer of the medical device (his authorized representative) may be carried out in accordance with the Rules or in accordance with the legislation of a member state of the Eurasian Economic Union."
Thus, until December 31, 2021, the manufacturer or his authorized representative has a choice - how to register a medical device:
1) In accordance with the EAEU Rules (link to rules in the profile header). http://docs.cntd.ru/document/456008980
2) In accordance with the legislation of a member state of the Eurasian Economic Union.
After December 31, 2021, it will be possible to register a medical device only in accordance with the EAEU Rules.

The registration process will be even easier and faster if you avoid some mistakes. For example, in the description of t...
26/01/2021

The registration process will be even easier and faster if you avoid some mistakes. For example, in the description of the purpose of a medical device (MI). According to the rules, it must contain the technical aspects of the appointment, that is, the device and / or the principle of operation and / or the action of the MI itself, ensuring the fulfillment of the intended medical task, as well as the medical aspects of the appointment.

In addition, the purpose of the medical device specified in the registration application must match the purpose specified in the technical and operational documentation (for example, in the technical specifications and operating manual).

An example of a description of the purpose of an MI can be the purpose of an MI similar to yours in the classifier on the Roszdravnadzor website.

Question of the week: is the approval signature on the Technical Conditions mandatory after the technical tests?The answ...
26/01/2021

Question of the week: is the approval signature on the Technical Conditions mandatory after the technical tests?

The answer is pretty simple. For a foreign manufacturer, it is optional. But for the Russian, the approval signature is part of the standard requirements, and without it a medical device cannot be registered.

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Do you need a high-quality expert translation of the documentation into a foreign language? We will take on this task. T...
26/01/2021

Do you need a high-quality expert translation of the documentation into a foreign language? We will take on this task. The staff of professional medical translators «Regfort» will be responsible for translating your documents from any language, and will also prepare notaries for them in just two days.
Ask your question to the ««Regfort» » translation department, writing in translate@regfort.com.

When preparing documents, our customers often have the question - who is the authorized manager?According to the officia...
26/01/2021

When preparing documents, our customers often have the question - who is the authorized manager?
According to the official wording *, "authorized representative of the manufacturer (manufacturer)" is a legal entity or individual entrepreneur registered in the territory of the Russian Federation, authorized by the manufacturer (manufacturer) of a medical product to represent his interests on issues of medical product circulation in the territory of the Russian Federation, including on conformity assessment procedures and state registration, in whose name a registration certificate for a medical product can be issued.
* As amended by Decree of the Government of the Russian Federation dated 17.07.2014 N 670, dated 31.05.2018 N 633

The manufacturer sometimes makes an unfortunate mistake, which increases the time and budget for registration. We are ta...
26/01/2021

The manufacturer sometimes makes an unfortunate mistake, which increases the time and budget for registration. We are talking about the incorrectly painted composition of the medical product with its accessories.
For example, there are no accessories in the application. And in the technical (TD) and operational documentation (OD) - indicated. Or, according to the manufacturer's TD and OD data, the product does not have accessories.
Here is what you should pay attention to when submitting documents:
1) Medical products included in the delivery package with registered medical products must be included in its composition.
2) Non-medical products can be included both in the composition and in the list of accessories of the registered medical product.
3) Special software is also a medical product.
4) The delivery set (composition and accessories) in the application, TD and ED shall be specified uniformly.
5) All possible variants and sizes shall be prescribed.
6) Operational documentation is also included in the medical product.
Unfortunately, an incorrectly scheduled line-up will cause the registration to fail.

Important news from Federal Health Oversight Service!The Government of the Russian Federation has simplified * the regis...
26/01/2021

Important news from Federal Health Oversight Service!
The Government of the Russian Federation has simplified * the registration procedure for 363 items of medical products - respirators, medical masks, insulating robes and suits, as well as gloves and shoe.
For initial registration, the applicant must provide Federal Health Oversight Service with a copy of the document confirming the applicant's authority, technical and operational documentation, photographs of the general type of medical product and an inventory of documents.
Federal Health Oversight Service within three days will consider the initial documents and in the absence of claims will issue a registration certificate in five days.
After that, the manufacturer is given five months to confirm the safety and quality of the product. Including clinical, toxicological and technical studies performed on the basis of the FSBI VNIIIMT of Federal Health Oversight Service. In case of non-conformity, the previously issued registration certificate may be revoked.
* Resolution No. 430 of 03.04.2020 (ed. 02.06.2020)

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