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Medical devices in 2021: TR CU / GOST R / refusal/ replacement of RU


Medical devices in 2021: TR CU / GOST R / refusal/ replacement of RU

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The market for medical devices is in turmoil.

Since January 1, 2021, quite a lot of regulations have been canceled or lost their force.

Let's get this straight.

Hello everyone.

Indeed, from January 1, 2021 was abolished or repealed the following regulatory documents:

- decree No. 982 dated 01.12.2009 g, No. 469 dated 03.06.2013 №1360 from 12.12.2015.;

orders: No. 325 of 20.08.1996 g, No. 106 from 01.04.2002 №697н from 08.09.2009 №12h of 20.06.2012, No. 175н from 14.09.2012 №70н from 15.02.2013, and so on.

All these measures are implemented within the framework of the "regulatory guillotine" mechanism


This is a tool for large-scale revision and cancellation of regulatory acts that negatively affect the business climate, that is, in general, nothing terrible has happened, but on the contrary, this is all for you.

And yet many companies have a problem with misunderstanding, and what to do next?

Let's try to figure it out.

We will start with the 982 decree because all medical devices were excluded from it. And if earlier it was possible to make a declaration for 982 the decision on the basis of the registration certificate (RU), then now this can not be done. But all the declarations issued earlier, that is, last year, continue to operate because there is no regulatory document to cancel these declarations.

Conclusion: the declaration on the 982 resolution, also called GOST R, is no longer required.

The next point is the Technical Regulation of the Customs Union on electromagnetic compatibility (TR CU 020/2011), is it necessary or not for medical devices?

Here I will answer as follows, that everyone will need to decide on their own.

I'll give you the facts, and you can decide for yourself.

If you look at the Technical Regulation of the Customs Union 020/2011 "Electromagnetic compatibility of technical means", then in the list of products

there are no medical products that are subject to mandatory confirmation of compliance by certification, but if you look at what this Technical Regulation does not apply, then it says that products that do not fall into the Unified List of Products for which mandatory requirements are established within the Customs Union. And if you look at this list, then under item # 40 we will find "medical devices". In other words, if you look within the framework of legislation, a declaration on electromagnetic compatibility for medical devices is required, but the declaration itself is not asked anywhere.

Of course, this issue will be finally resolved when the Technical Regulation "On the safety of Medical Devices" comes into force, but this will not be until next year,but this is not certain. So far, there is only a draft of this Technical Regulation, but in the meantime, decide for yourself whether you need it or not.

The next thing I would like to draw your attention to is Resolution No. 1416 of December 2012.

According to this decree, all registration certificates that were issued before December 2012 were subject to replacement until January 1, 2021, and these registration certificates could be replaced without repeated tests under a simplified procedure, but if you did not have time to do this, you will need to go through the entire procedure again.

To summarize.

Of course, the main problems faced by medical device suppliers are mainly related to the Federal Customs Service, because brokers out of habit ask you for declarations under the 982 resolution.

What are the possible solutions?

The most correct solution is to convince the broker that he does not need any more declaration and you do it once, and then everything will work "on the roll".

But if you can't convince your broker, then there are two alternative solutions:

- the first solution is to try to make a refusal decision from the certification body that the declaration will not be issued;

- the second solution is to make a declaration according to Technical Regulation 020/2011 on electromagnetic compatibility.

And that's it for me.

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Have a nice day.

Have a question? Call 8 499 647-75-64 or write info@notifikat.ru

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