Registration of Class III Medical Devices in UAE

N

Nanoula

#1
Hi!!!!!!!!!!

Does anyone could help me?
We have a client which is distributor of medical device class III in EU. The manufacturer is based in EU. The manufacturer has appointed the distributor to register/export/ the medical devicesin UAE, Saudi Arabia and Egypt
Can the EU distributor proceed to the registration of the medical devices in MENA region?
We have adressed the a.m. request to the Health Authorities but we didn't get an answer.
Thank you
 
Elsmar Forum Sponsor
A

Access2hc

#3
Re: Registration of Medical Devices in UAE

Just curious - what was the initial concern for not registering immediately, were there any?

Cheers,
Ee Bin
 
N

Nanoula

#4
Re: Registration of Medical Devices in UAE

My client wants to register the medical device in UAE, Saudi Arabia and Egypt
 
N

Nanoula

#5
Re: Registration of Medical Devices in UAE

The initial concerns is that the manufacturer does not want to proceed to export in Middle East and he has appointent an EU DISTRIBUROR to proceed to the registration procedure and exports.
 

tibon74

Involved In Discussions
#6
Re: Registration of Medical Devices in UAE

Hi !
does anybody has information about medical device approval process in Egypt ?
 

fialor

Involved In Discussions
#7
Re: Registration of Medical Devices in UAE

Hi !
does anybody has information about medical device approval process in Egypt ?
It might be best for you to post on a separate tread for Egypt.
However I can share the following:
DPPC division controls registration through committee for the study of manufactured and imported medical device and equipment.
Class I, Class IIa and Class IIb are registered at the DPPC.

Not a lot of information but at least its a start.
 

tibon74

Involved In Discussions
#8
Re: Registration of Medical Devices in UAE

Thank you! I suppose that class III are regulated by CAPA, right ?
it would be very help if I have a list of needed documents
 
Thread starter Similar threads Forum Replies Date
F CLASS III - Preparing a registration dossier for a dermal filler Other Medical Device Regulations World-Wide 8
F Class III Medical Device (Contact Lenses) Registration Timescale in Japan Japan Medical Device Regulations 4
E Special Class III Medical Device registration requirements in Germany and France EU Medical Device Regulations 2
M Class III Medical Device Registration in Russia Other Medical Device Regulations World-Wide 6
V Class III Device CE Mark with ISO 9001 Registration? EU Medical Device Regulations 4
R Class III Medical Device with CE Mark - UK Registration Process EU Medical Device Regulations 6
S Class III Medical Device Registration and Requirements in Iraq Other Medical Device Related Standards 9
J Class III Medical Device with CE Mark Approval - India Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 10
K Class I Medical Device Registration EU Medical Device Regulations 11
M Class A Device Registration in Singapore - Disclosure of Manufacturing Sites Other Medical Device Regulations World-Wide 6
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 11
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
N Registration of Class I Medical Device in UK EU Medical Device Regulations 2
M Myanmar: Class I/II Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
M Portugal Class I Medical Device Registration of device made in Italy EU Medical Device Regulations 1
M Spain Class I Medical Device Registration EU Medical Device Regulations 14
W Mauritius Class IIA Medical Device Registration Requirements Other Medical Device Regulations World-Wide 3
B Sri Lanka Class IIb Medical Device Registration Other Medical Device Regulations World-Wide 4
B Singapore Class C Device Registration - Time & Cost? Other Medical Device Regulations World-Wide 3
M SFDA Registration Fees for a Class II Product in China China Medical Device Regulations 2
B Bangladesh Class IIA Medical Device MDD Registration Requirements Other Medical Device Regulations World-Wide 6
E Registration & Listing of a Dental Device - Class Enforcement Descretion 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Class I Medical Device Registration (STED) requirements in China China Medical Device Regulations 1
D Registration of Class IV Device -Clinical Data and ISO Certificate Canada Medical Device Regulations 3
I Medical Device Registration Process in Italy - Class I and Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
B 510k exempt Class I Medical Device - Confusion during the facility registration US Food and Drug Administration (FDA) 3
L Class II Electrical Medical Device Registration Requirements in Costa Rica Other Medical Device Regulations World-Wide 2
M Medical Device Class II Registration 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J CE Marking a CE marked Class I Medical Device - To aid approval/registration in China EU Medical Device Regulations 7
R Registration Requirements for Class I Medical Devices in EU? EU Medical Device Regulations 5
N Registration/Homologation Colombia & Cuba - Class I and IIa medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
T Health Canada Registration - New Class II Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
chris1price What Class 1 Medical Device Registration is required to sell in Poland EU Medical Device Regulations 3
S NCR under MDD - No documented procedure for class I device registration mechanism ISO 13485:2016 - Medical Device Quality Management Systems 2
S Registration of IVD in South Africa Other Medical Device Regulations World-Wide 2
A EUDAMED registration fees EU Medical Device Regulations 6
I Registration of MD software IEC 62304 - Medical Device Software Life Cycle Processes 0
G FDA Annual Registration and Listing US Food and Drug Administration (FDA) 7
S Turkey- SUT match- GTIN changes caused re-registration Other Medical Device Regulations World-Wide 0
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
D Software Registration GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
H Registration for REACH required for Non-EU Down Stream Manufacturer? REACH and RoHS Conversations 3
S Additional registration requirements for different EU-states on top of standard CE-registration? EU Medical Device Regulations 3
T Med Dev India Registration Other Medical Device Regulations World-Wide 0
G Query on the pharmaceutical excipients registration in Korea Various Other Specifications, Standards, and related Requirements 1
A Registration of medical devices in Greece EU Medical Device Regulations 5
I Legacy device EUDAMED registration EU Medical Device Regulations 7
B EUDAMED 2 Different Registration EU Medical Device Regulations 1
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom