Medical Device Regulations in Belarus

[apollon]

Dear Cove,

I have been looking for ages for information on what medical device regulations there are in Belarus.

In several places I read THAT there is a New Law on Medical Devices (e.g. in the article on MDDIonline which has been posted in this forum*), but not WHAT it actually says.
The only information I found (on http://medical-promek.com) cites a law passed in 1998 while according to the first source (and several others), the new law was passed in 2010.

I know that with the formation of EURASEC new laws can be expected any time soon, but as far as I know, these new regulations have not been adopted yet.

Thanks a lot!

*As my post count is below 5, I cannot post URLs, so sorry for that.

 

[Marcelo]

Not the text, but there´s a table with some information on page 28 of the following document - http://www.bsiamerica.com/upload/MS-Assessment+Certification/Subject-Areas+Sectors/Healthcare+Medical-Devices/Documents/HK_CAB/HKRF-Newsletter-%20Feb2011.pdf

 

[Marcelo]

Ok, after some google translating - this is the regulation, in Russian - http://tnpa.by/ViewFileText.php?UrlRid=110796&UrlOnd=%D2%D0%202010/006/BY

It´s know as TR 2010/006/BY

 

[Marcelo]

Found a PDF. Now you only need to use google translate to get a good idea of the regulation.

 

[carmenso]

Dear Marcelo Antunes & apollon,

I have a question relating to Belarus MD and hope you would have some ideas.

Our company is importing MD from Belarus to Thailand.
As a requirement by Thailand, they need a Free sale certificate from the Country of Origin. but from my understanding, there is no FSC in Belarus.

Would you or any one know of other ways to issue certificates similar to a FSC?

I would much appreciate your help.

 

[apollon]

Finally got the time to actually write a reply. Thanks a lot, Marcelo Antunes!
Could you tell me where you got that PDF from, so I can specify my sources?
I searched the internet for that filename but didn't find anything. I guess it's from the TNPA website? I also looked around there but couldn't find a link to any actual file, just lists of what they are supposed to have in their archive.

@carmenso Sorry, no idea about that. Thank god I only have to worry about regulations for IMporting, enough of a task.

PS: I won't be here until early April, so thanks in advance for anything that might come up; I'll appreciate it once I'm back

 

[sreenu927]

Hi Carmenso,

As per Thai regulations, you need an FSC from Country of Origin. But in reality,it really doesn;t require.... I suggest you check with your distributor whether it is a mandatory or not.

Apart from the Health regulatory Authority, in some Countries, Customs department will also issue a Certificate for Free Sale. You may check with Belarus Customs Department.

Regards,
Sreenu

 

[Marcelo]

Hello Carmenso and welcome to the Cove.

The FSC is a a document which reg systems in general require (it's part of international trade). However, most of the reg systems also permit other options due to the fact that not all countries issue a FSC. You really need to verify

1- If Belarus really does not emit FSC and if so, if they do not have a similar document

2 - clearly verify of is reuired in Thailand. From my understanding a FSC is really required, however, I'm not sure if another type of document can be accepted in this case.

 

[carmenso]

Dear All,

Thank you all for your input!

Please correct me if I have this wrong, for all MD we will need GostR and GostRegistratze (hygienic certificate).

We have tried with our Belarus office, and the closest we could get was a Certificate of Origin. But this is too general and does not specify the article number etc.

Our Thailand counterpart says we will need a legalized FSC from COO.

well, what we are trying to get is any official document from a Belarus government department, certifying the product (with article number) is made in the production site in Belarus.

I would much appreciate your input and will try the Customs Department and see if they have anything like that.

Thanks so much again!

 

[maya_tanase]

Hello everybody,

I hope you can help me find some answers on a related matter... the authorized representative to act as applicant for the medical device registration in Belarus (on behalf of a foreign manufacturer).

1) First, is this AR actually required (by law) to register and market medical devices in Belarus or can the manufacturer do it themselves? (I have found conflicting information on the matter)
2) Secondly, if the AR is actually required, how tied is the manufacturer to them? Does the AR become the license/registration certificate holder? Could the license be transferred to another entity? (how?)

Follow-up:

• Would the Manufacturer be allowed to register other product lines with different/other AR?
• Would the Manufacturer be allowed to register the same product line with another AR? (more than one, simultaneously)
• Would the Manufacturer be allowed to register the same product line, but under a different trade name (and code) with a different/another AR?

3) In the event that the relationship between the Manufacturer and AR (the one who initially registered the product and obtained the license) is interrupted, would the Manufacturer be allowed to redo the registration WITHOUT depending on the consent of the initial AR?

4) The national registration procedure (link: Гоенная медикиделий ) vs. the new registration procedure for medical devices (among other products) on the Eurasian Union market, Rules for registration and examination of safety, quality and efficacy of medical products approved by Decision of the EEC Council No. 46 of February 12, 2016.

"Effective since 01/01/2016, Russia, Belarus and Kazakhstan (members of the Eurasian Economic Union, EAEU) agreed on common principles and rules of circulation for medical devices. This includes common classification, registration and quality control procedures, as well as mutual acceptance of testing data and registration certificates. Medical devices that have successfully passed the registration procedure shall be labeled by the manufacturer or his/her authorized representative with a EAC mark before the products will be placed on the market within the EAEU."
(source: Russia, Belarus and Kazakhstan agreed on common principles and rules of circulation of medical devices )

Could somebody confirm that these regulations are already enforced:

"Until December 31, 2021 within the EAEU two procedures for releasing medical products in circulation will coexist - under uniform requirements of the Union and in accordance with the legislation of the EAEU countries."
(source: The EEC generally completed formation of the regulatory framework of the EAEU for launching the common market of medical products )

I am extremely grateful to anybody who can shed some light on the matter
Thank you!