UAE Device Regulation and Registration for Public and Private market

C

chloep17

#1
Can any one shed any light on the registration policies in the UAE and whether they differ between the public and private market? We have been advised that you can sell unregistered product into the private market but do not feel this is correct due to the registration requirements.

Any information would be greatly appreciated.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Can any one shed any light on the registration policies in the UAE and whether they differ between the public and private market? We have been advised that you can sell unregistered product into the private market but do not feel this is correct due to the registration requirements.

Any information would be greatly appreciated.
Please scroll down to the bottom of this page for some threads that seem relevant.

Cheers,
Ronen.
 
C

chloep17

#3
Many thanks for the response Ronen, unfortunately the previous posts don't answer the specific question.
 
#4
Can any one shed any light on the registration policies in the UAE and whether they differ between the public and private market? We have been advised that you can sell unregistered product into the private market but do not feel this is correct due to the registration requirements.

Any information would be greatly appreciated.
Can you clarify both the public and private market?
Do you mean prescription v OTC?
Thank you. :)
(I have done UAE registrations and may be able to help)
 
C

chloep17

#5
Thank you for your response Joanne, I would assume that private is paid for by the consumer and public by the government. This may not be the case in the UAE though? Are all medical devices sold via Tenders?

We have been trying to find a company that can help with regulatory requirements and Local Representation but have been unsuccessful so far. Did you use your distributor as the LR?
 
M

mikejoness

#9
I am in the same boat. I want to sell/distribute medical devices in the UAE.

Not sure how to get this ball rolling
 

Wes Bucey

Prophet of Profit
#10
I am in the same boat. I want to sell/distribute medical devices in the UAE.

Not sure how to get this ball rolling
Can you clarify - are you a manufacturer or a direct agent of one? Alternately, are you an independent wholesaler/retailer of medical devices from several manufacturers hoping to break into the UAE market?
 
Thread starter Similar threads Forum Replies Date
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
F Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
R UAE Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
R Medical Device Registration in the UAE Other Medical Device Regulations World-Wide 1
I Medical Device Distributor Requirements in the UAE Other Medical Device Regulations World-Wide 3
W United Arab Emirates (UAE) Medical Device Requirements? ISO 13485:2016 - Medical Device Quality Management Systems 11
M Medical Devices Regulations and labelling requirements UAE Other Medical Device Regulations World-Wide 0
Sidney Vianna Well-oiled racket involving sale of ISO certificates uncovered in the UAE Registrars and Notified Bodies 11
N Registration of Class III Medical Devices in UAE Other Medical Device and Orthopedic Related Topics 7
L Can I ship Demo Units to the UAE if we are not Approved? Other Medical Device and Orthopedic Related Topics 2
C UAE and Dubai Disinfectant/Sterilizing Product Approval Other Medical Device and Orthopedic Related Topics 1
K What are the challenges of working in UAE as an Auditor ? General Auditing Discussions 2
H List of Language requirements for Jordan, Iraq, Libya, Oman, Lebanon, UAE, Yemen, Sau Other Medical Device Regulations World-Wide 7
S MDDI article on UAE, Saudi, Belarus, Ukraine, Turkey, Russia Regulations Other Medical Device Regulations World-Wide 0
R Requirements for Exporting Class III Medical Devices into the UAE from the US or EU ISO 13485:2016 - Medical Device Quality Management Systems 2
D UAE IVD Registration (Professional Use Only, Non-A, Non-B of EU Regulation) Other Medical Device Regulations World-Wide 7
S Anyone familiar with using an Authorized Representative in the UAE? Other Medical Device Regulations World-Wide 2
B Environmental Awards in UAE or GCC (Gulf Cooperation Council) countries Miscellaneous Environmental Standards and EMS Related Discussions 1
C VOCs as extractable in substance based medical device EU Medical Device Regulations 0
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
Ed Panek GDocP For Med Device US Medical Device Regulations 3
B Clinical evaluation according to equivalence with another device EU Medical Device Regulations 4
E Insulation class II device with metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
T § 820.120 Device labeling - "shall be documented in the DHR" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 3
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
K Device part of combination product certification requirements Medical Device and FDA Regulations and Standards News 3
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
I Medical Device Accessory Responsibility Other Medical Device Related Standards 7
A NMPA registered device VS country of origin (free sales certificate) China Medical Device Regulations 4
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
E Device compatibility with other company's devices US Food and Drug Administration (FDA) 0
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
A Biocompatibility: Selection of worst-case device Medical Device and FDA Regulations and Standards News 2
J Medical Device Manufacturing Manufacturing and Related Processes 3
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
J Question regarding classification of custom made device EU Medical Device Regulations 5
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom