SBS - The Best Value in QMS software

Republic Of Georgia Medical Device Regulations for IVD

#1
Hi,

I'm researching the medical device regulations for the Republic of Georgia and am having a hard time finding anything too specific. I found a document from 2011 called "Overview and Legal Analysis of Healthcare Legislation" (attached) which talks about medical device registration requirements, but it states that there is no current (as of 2011) supervision or control of medical devices that are on the market there.

I was wondering if anyone had any more up to date information on what the regulations are in Georgia now or if they could elaborate on the process / oversight as it is today.

Thanks much!!
 

Attachments

Elsmar Forum Sponsor

Gamula

Involved In Discussions
#4
Dear EyesWideOprn,

thank you for the data.

I have a question regarding the medical device registration:

We have a CE mark for all of our devices which are ranging from class 1 till class 3.

Now, I do not understand the registration in Gerogia, it is almost a member of the EU and it still has its own non-transparent regulations. We try to understand the demand of an own registration procedure together with the problem, that they just gave us information via our local agent.

Now, who is also not understanding this situation.

Best
Gamula
 
D

Dirk_REGULA

#5
Dear all,

I'm also looking for medical device registration requirements in the Republic of Georgia.
Does anyone have any news?
Thanks a lot,
Dirk
 

Gamula

Involved In Discussions
#6
Hi Dirk_REGULA,

here is a general list of items, wich will be needed for registration. But, ask your agent or an agency for detailled data.

1) The letter on behalf of firm for your representatives
2) Information on a product, the structure if what it consists.
3) The supporting document the product is registered in e. g. Germany and on what the period of time it (it is termless)
4)Instruction, quality certificates ISO or EC certificate.
5) Identification number for the license for trade.
6) Production method
7) Data on item that it is not toxic, not mutagen.
8) Original model of marking .
9) Release form, structure set.
10) Sample.

If you get more information we would like to get them shared :agree1:

Cheerio!
 
#7
Does anyone have more information about medical device regulations in Georgia?
-Is local representative required?
-Is registration mandatory for Class I device?
-any specific labeling requirement?
 
Thread starter Similar threads Forum Replies Date
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 7
D Experience with Notified Body - ITC from Czech Republic for Medical Devices Registrars and Notified Bodies 15
S Medical Device Registration in Republic of Moldova Other Medical Device Regulations World-Wide 0
M Dominican Republic Medical Device Registration Requirements Other Medical Device Regulations World-Wide 6
M Medical Device Registration in Czech Republic EU Medical Device Regulations 7
Ajit Basrur Happy Republic Day, India Coffee Break and Water Cooler Discussions 0
J Disinfectant Registration in Republic of Korea (South Korea) Other Medical Device Regulations World-Wide 2
C Apostille of French Commercial Documents for the Republic of Turkey EU Medical Device Regulations 5
Ajit Basrur 26 January - India's Republic Day Coffee Break and Water Cooler Discussions 3
D Register of Legislation for Czech Law - Czech Republic Miscellaneous Environmental Standards and EMS Related Discussions 1
T List of Medical Devices - Registered in Republic of Indonesia Other Medical Device Regulations World-Wide 1
Ajit Basrur Georgia Woman Revealed as Voice of Siri Coffee Break and Water Cooler Discussions 2
Sidney Vianna 2010 CB Aerospace Auditor Workshop scheduled for July in Atlanta, Georgia AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C Georgia vs. Georgia Tech Coffee Break and Water Cooler Discussions 1
R QMS for Medical products & Pharmaceutical Drugs in one facility Medical Device and FDA Regulations and Standards News 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
U EN 455-4 Accelerated Shelf Life tests for Medical Gloves Other Medical Device Related Standards 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Statistics and / or Forecasts on medical products exports from China Other Medical Device and Orthopedic Related Topics 1
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
F Medical cart self certification EU Medical Device Regulations 1
D Clinical Trial for Medical devices in Canada Canada Medical Device Regulations 1
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 0
M California Board of Pharmacy License for Medical Devices?? Other US Medical Device Regulations 6
P Retention Samples for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
A Medical First Article - Can it be a Delta? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6

Similar threads

Top Bottom