Israel: 1 Medical Device, Multiple Registrations = Possible?

3

3l5m4r

#1
Hi there,

Well- I guess, the title says it all: Is it possible to register the same medical device more than once in Israel? (only difference would be the Registration holders)

I've heard multiple answers, but none of them was based on any form of evidence (e.g. an official document). Is there anyone out there who knows whether there's any official statement implying that this is / is not possible?

I'd be glad, if someone could help me out with this (ideally asap)... ...thx
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi there,

Well- I guess, the title says it all: Is it possible to register the same medical device more than once in Israel? (only difference would be the Registration holders)

I've heard multiple answers, but none of them was based on any form of evidence (e.g. an official document). Is there anyone out there who knows whether there's any official statement implying that this is / is not possible?

I'd be glad, if someone could help me out with this (ideally asap)... ...thx
Hi,

I've done a quick review of the law, the regulations and the explanatory publications in the Israeli Ministry of Health website, and I couldn't find any explicit statement in that regard (either way).

the law and regulations language implies that there could be multiple registrations / registration holders for the same device; however I felt like that option was slightly overlooked and some of the details are not 100% consistent with multiple registrations, or there's at least some grey area.

Please note that the above is the result of a rather quick and informal review. A full, formal review, concluding in a well-renationalised report (including specific legal source pointers) would take several hours. Please PM me if that's what you are after.

Cheers,
Ronen.
 
3

3l5m4r

#3
@Ronen: thanks a lot for your efforts.

well, i guess it doesn't help a lot, if that has been overlooked so far and would theoretically be possible, but might then actually result in a rejection...
...there seems to be no other option than to try and submit...

i'll keep you up to date as soon as i can share any experiences or somehow learn something new any other way...

-3l5m4r
 
Thread starter Similar threads Forum Replies Date
D How to identify and confirm that the developed device fall under Israel electro medical device category Other Medical Device Regulations World-Wide 0
D How to identify and confirm that the developed device fall under Israel electro medical device category Other Medical Device Regulations World-Wide 1
B Israel Demonstration Medical Device Requirements Other Medical Device Regulations World-Wide 5
B Israel Medical Device registration Other Medical Device Regulations World-Wide 3
Z Definition of a Medical Device in Israel's Regulations Other Medical Device Regulations World-Wide 11
P Selling Medical Devices from the US into Israel Other Medical Device Regulations World-Wide 2
N Exporting Class III Medical Devices to Canada from Israel Canada Medical Device Regulations 12
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
Hershal Interesting Israel Holiday Coffee Break and Water Cooler Discussions 6
T Post Market Surveillance Requirements in Israel Other Medical Device Regulations World-Wide 17
Howard Atkins Agassi, Renault Nissan & Israel announce project for oil-independent country - 2008 World News 2
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Medical Device Accessories Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
J Medical software Patient outcome Medical Information Technology, Medical Software and Health Informatics 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
JoCam Warranty of Medical Devices EU Medical Device Regulations 2
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
R Obsolesce medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 Other Medical Device Regulations World-Wide 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3

Similar threads

Top Bottom