Regulatory Open Forum

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Charnelle,

 Part of MDR transition is to make sure the IFU are available within number of days(3 as i recall), continually throughout the Product lifecycle. Paper based Manuals will be replaced by electronic means(PDF/Notes/Instruction videos and troubleshooting checklists) as applicable and continually on request via post or over the Internet. 
   This Link[1] is for the e-IFU lists applicable regulation globally and [3] lists applicability by NB. [3] is for Non EU/US region.


[1]: https://dokspot.io/blog/
[2]: https://www.spectaris.de/fileadmin/Infothek/Medizintechnik/Positionen/20190508_SPECTARIS_Positionspapier_eIFU_final.pdf
[3]: https://www.regdesk.co/sfda-eifu/
Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

Country	Is insert required for import? YES or NO	Labeling language	Will a generic insert with instructions of where to find the IFU acceptable？	Electronic Insert ok?  YES or NO	End User Needs Printed Insert?  YES or NO	Can electronic access use a secure login ID and Password? YES or NO
Australia	No	English	No	No	Yes	N/A
Bangladesh	Yes	English	No	No	Yes	Yes
Brazil	No	Portugese	Yes	Yes	No	Yes
China	Yes	Chinese	No	No	Yes	Yes
Chile	No	Spanish	Yes	Yes	No	Yes
Colombia	No	Spanish	No	No	Yes	Yes
Costa Rica	No	Spanish	Yes	Yes	No	Yes
Denmark	No	Danish	Yes	Yes	No	Yes
Greece	No	Greek	Yes	Yes	No	Yes
Hong Kong	Yes	English	No	No	Yes	Yes
India	Yes	English	Yes	Yes	No	Open access
Israel	No	English	Yes	Yes	No	Yes
Japan	No	Japanese	N/A	N/A	Yes	Open access
Jordan	Yes*	English	Yes	Yes	No	Yes
Korea	Yes	Korean	Yes	Yes	No	Yes
Kuwait	No	English	Yes	Yes	No	Yes
Malaysia	Yes	English	Yes	Yes	No	Yes
Mexico	No	Spanish	No	No	Yes	Open access
Mongolia	Yes	English	Yes	Yes	No	Yes
Moldova	No	English	Yes	Yes	Yes*	Yes
Myanmar	No	English	No	No	Yes	N/A
Norway	No	Norwegian	Yes	Yes	No	Yes
Panama	Yes	Spanish	Yes	Yes	No	Yes
Peru	Yes	Spanish	Yes	Yes	No	Open access
Philippines	No	English	No	No	Yes	Yes
Poland	Yes	Polish	Yes	Yes	Yes	Open access
Portugal	No	Portugese	Yes	Yes	Yes	Yes
Salvador	No	Spanish	No	No	Yes	Yes
Singapore	Yes	English	Yes	Yes	Yes	Yes
Taiwan	No	Traditional Chinese	No	No	Yes	N/A
Tanzania	Yes	English	No	No	Yes	N/A
Thailand	Yes	English	Yes*	Yes	Yes	Yes
UAE	Yes*	English	No	No	Yes	Open access
Uruguay	Yes	Spanish	No	No	Yes	No*
Viet Nam	Yes	Vietnamese	No	No	Yes	Yes

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States
------------------------------

Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

This is great! Thank you so much!

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

Original Message:
Sent: 23-Aug-2021 12:11
From: Qianqian Zhu
Subject: eIFU Globally

Country	Is insert required for import? YES or NO	Labeling language	Will a generic insert with instructions of where to find the IFU acceptable？	Electronic Insert ok?  YES or NO	End User Needs Printed Insert?  YES or NO	Can electronic access use a secure login ID and Password? YES or NO
Australia	No	English	No	No	Yes	N/A
Bangladesh	Yes	English	No	No	Yes	Yes
Brazil	No	Portugese	Yes	Yes	No	Yes
China	Yes	Chinese	No	No	Yes	Yes
Chile	No	Spanish	Yes	Yes	No	Yes
Colombia	No	Spanish	No	No	Yes	Yes
Costa Rica	No	Spanish	Yes	Yes	No	Yes
Denmark	No	Danish	Yes	Yes	No	Yes
Greece	No	Greek	Yes	Yes	No	Yes
Hong Kong	Yes	English	No	No	Yes	Yes
India	Yes	English	Yes	Yes	No	Open access
Israel	No	English	Yes	Yes	No	Yes
Japan	No	Japanese	N/A	N/A	Yes	Open access
Jordan	Yes*	English	Yes	Yes	No	Yes
Korea	Yes	Korean	Yes	Yes	No	Yes
Kuwait	No	English	Yes	Yes	No	Yes
Malaysia	Yes	English	Yes	Yes	No	Yes
Mexico	No	Spanish	No	No	Yes	Open access
Mexico	Yes*	Spanish	Yes	Yes	No	Yes
Mongolia	Yes	English	Yes	Yes	No	Yes
Moldova	No	English	Yes	Yes	Yes*	Yes
Myanmar	No	English	No	No	Yes	N/A
Norway	No	Norwegian	Yes	Yes	No	Yes
Panama	Yes	Spanish	Yes	Yes	No	Yes
Peru	Yes	Spanish	Yes	Yes	No	Open access
Philippines	No	English	No	No	Yes	Yes
Poland	Yes	Polish	Yes	Yes	Yes	Open access
Portugal	No	Portugese	Yes	Yes	Yes	Yes
Salvador	No	Spanish	No	No	Yes	Yes
Singapore	Yes	English	Yes	Yes	Yes	Yes
Taiwan	No	Traditional Chinese	No	No	Yes	N/A
Tanzania	Yes	English	No	No	Yes	N/A
Thailand	Yes	English	Yes*	Yes	Yes	Yes
UAE	Yes*	English	No	No	Yes	Open access
Uruguay	Yes	Spanish	No	No	Yes	No*
Viet Nam	Yes	Vietnamese	No	No	Yes	Yes

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States

Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Great! Which source did you use?
Original Message:
Sent: 23-Aug-2021 12:11
From: Qianqian Zhu
Subject: eIFU Globally

Country	Is insert required for import? YES or NO	Labeling language	Will a generic insert with instructions of where to find the IFU acceptable？	Electronic Insert ok?  YES or NO	End User Needs Printed Insert?  YES or NO	Can electronic access use a secure login ID and Password? YES or NO
Australia	No	English	No	No	Yes	N/A
Bangladesh	Yes	English	No	No	Yes	Yes
Brazil	No	Portugese	Yes	Yes	No	Yes
China	Yes	Chinese	No	No	Yes	Yes
Chile	No	Spanish	Yes	Yes	No	Yes
Colombia	No	Spanish	No	No	Yes	Yes
Costa Rica	No	Spanish	Yes	Yes	No	Yes
Denmark	No	Danish	Yes	Yes	No	Yes
Greece	No	Greek	Yes	Yes	No	Yes
Hong Kong	Yes	English	No	No	Yes	Yes
India	Yes	English	Yes	Yes	No	Open access
Israel	No	English	Yes	Yes	No	Yes
Japan	No	Japanese	N/A	N/A	Yes	Open access
Jordan	Yes*	English	Yes	Yes	No	Yes
Korea	Yes	Korean	Yes	Yes	No	Yes
Kuwait	No	English	Yes	Yes	No	Yes
Malaysia	Yes	English	Yes	Yes	No	Yes
Mexico	No	Spanish	No	No	Yes	Open access
Mexico	Yes*	Spanish	Yes	Yes	No	Yes
Mongolia	Yes	English	Yes	Yes	No	Yes
Moldova	No	English	Yes	Yes	Yes*	Yes
Myanmar	No	English	No	No	Yes	N/A
Norway	No	Norwegian	Yes	Yes	No	Yes
Panama	Yes	Spanish	Yes	Yes	No	Yes
Peru	Yes	Spanish	Yes	Yes	No	Open access
Philippines	No	English	No	No	Yes	Yes
Poland	Yes	Polish	Yes	Yes	Yes	Open access
Portugal	No	Portugese	Yes	Yes	Yes	Yes
Salvador	No	Spanish	No	No	Yes	Yes
Singapore	Yes	English	Yes	Yes	Yes	Yes
Taiwan	No	Traditional Chinese	No	No	Yes	N/A
Tanzania	Yes	English	No	No	Yes	N/A
Thailand	Yes	English	Yes*	Yes	Yes	Yes
UAE	Yes*	English	No	No	Yes	Open access
Uruguay	Yes	Spanish	No	No	Yes	No*
Viet Nam	Yes	Vietnamese	No	No	Yes	Yes

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States

Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

Each country's regulation/guidance documents, peer input, and distributor feedback.

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States
------------------------------

Original Message:
Sent: 24-Aug-2021 03:24
From: Anonymous Member
Subject: eIFU Globally

This message was posted by a user wishing to remain anonymous

Great! Which source did you use?
Original Message:
Sent: 23-Aug-2021 12:11
From: Qianqian Zhu
Subject: eIFU Globally

Country	Is insert required for import? YES or NO	Labeling language	Will a generic insert with instructions of where to find the IFU acceptable？	Electronic Insert ok?  YES or NO	End User Needs Printed Insert?  YES or NO	Can electronic access use a secure login ID and Password? YES or NO
Australia	No	English	No	No	Yes	N/A
Bangladesh	Yes	English	No	No	Yes	Yes
Brazil	No	Portugese	Yes	Yes	No	Yes
China	Yes	Chinese	No	No	Yes	Yes
Chile	No	Spanish	Yes	Yes	No	Yes
Colombia	No	Spanish	No	No	Yes	Yes
Costa Rica	No	Spanish	Yes	Yes	No	Yes
Denmark	No	Danish	Yes	Yes	No	Yes
Greece	No	Greek	Yes	Yes	No	Yes
Hong Kong	Yes	English	No	No	Yes	Yes
India	Yes	English	Yes	Yes	No	Open access
Israel	No	English	Yes	Yes	No	Yes
Japan	No	Japanese	N/A	N/A	Yes	Open access
Jordan	Yes*	English	Yes	Yes	No	Yes
Korea	Yes	Korean	Yes	Yes	No	Yes
Kuwait	No	English	Yes	Yes	No	Yes
Malaysia	Yes	English	Yes	Yes	No	Yes
Mexico	No	Spanish	No	No	Yes	Open access
Mexico	Yes*	Spanish	Yes	Yes	No	Yes
Mongolia	Yes	English	Yes	Yes	No	Yes
Moldova	No	English	Yes	Yes	Yes*	Yes
Myanmar	No	English	No	No	Yes	N/A
Norway	No	Norwegian	Yes	Yes	No	Yes
Panama	Yes	Spanish	Yes	Yes	No	Yes
Peru	Yes	Spanish	Yes	Yes	No	Open access
Philippines	No	English	No	No	Yes	Yes
Poland	Yes	Polish	Yes	Yes	Yes	Open access
Portugal	No	Portugese	Yes	Yes	Yes	Yes
Salvador	No	Spanish	No	No	Yes	Yes
Singapore	Yes	English	Yes	Yes	Yes	Yes
Taiwan	No	Traditional Chinese	No	No	Yes	N/A
Tanzania	Yes	English	No	No	Yes	N/A
Thailand	Yes	English	Yes*	Yes	Yes	Yes
UAE	Yes*	English	No	No	Yes	Open access
Uruguay	Yes	Spanish	No	No	Yes	No*
Viet Nam	Yes	Vietnamese	No	No	Yes	Yes

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States

Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

Qianqian,
Would you mind sharing the source for this great information? Or did you compile it?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 23-Aug-2021 12:11
From: Qianqian Zhu
Subject: eIFU Globally

Country	Is insert required for import? YES or NO	Labeling language	Will a generic insert with instructions of where to find the IFU acceptable？	Electronic Insert ok?  YES or NO	End User Needs Printed Insert?  YES or NO	Can electronic access use a secure login ID and Password? YES or NO
Australia	No	English	No	No	Yes	N/A
Bangladesh	Yes	English	No	No	Yes	Yes
Brazil	No	Portugese	Yes	Yes	No	Yes
China	Yes	Chinese	No	No	Yes	Yes
Chile	No	Spanish	Yes	Yes	No	Yes
Colombia	No	Spanish	No	No	Yes	Yes
Costa Rica	No	Spanish	Yes	Yes	No	Yes
Denmark	No	Danish	Yes	Yes	No	Yes
Greece	No	Greek	Yes	Yes	No	Yes
Hong Kong	Yes	English	No	No	Yes	Yes
India	Yes	English	Yes	Yes	No	Open access
Israel	No	English	Yes	Yes	No	Yes
Japan	No	Japanese	N/A	N/A	Yes	Open access
Jordan	Yes*	English	Yes	Yes	No	Yes
Korea	Yes	Korean	Yes	Yes	No	Yes
Kuwait	No	English	Yes	Yes	No	Yes
Malaysia	Yes	English	Yes	Yes	No	Yes
Mexico	No	Spanish	No	No	Yes	Open access
Mongolia	Yes	English	Yes	Yes	No	Yes
Moldova	No	English	Yes	Yes	Yes*	Yes
Myanmar	No	English	No	No	Yes	N/A
Norway	No	Norwegian	Yes	Yes	No	Yes
Panama	Yes	Spanish	Yes	Yes	No	Yes
Peru	Yes	Spanish	Yes	Yes	No	Open access
Philippines	No	English	No	No	Yes	Yes
Poland	Yes	Polish	Yes	Yes	Yes	Open access
Portugal	No	Portugese	Yes	Yes	Yes	Yes
Salvador	No	Spanish	No	No	Yes	Yes
Singapore	Yes	English	Yes	Yes	Yes	Yes
Taiwan	No	Traditional Chinese	No	No	Yes	N/A
Tanzania	Yes	English	No	No	Yes	N/A
Thailand	Yes	English	Yes*	Yes	Yes	Yes
UAE	Yes*	English	No	No	Yes	Open access
Uruguay	Yes	Spanish	No	No	Yes	No*
Viet Nam	Yes	Vietnamese	No	No	Yes	Yes

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States

Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------

Sorry. Just realized you answered this question above!

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 30-Aug-2021 11:07
From: Jackie Jaskula
Subject: eIFU Globally

Qianqian,
Would you mind sharing the source for this great information? Or did you compile it?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 23-Aug-2021 12:11
From: Qianqian Zhu
Subject: eIFU Globally

Country	Is insert required for import? YES or NO	Labeling language	Will a generic insert with instructions of where to find the IFU acceptable？	Electronic Insert ok?  YES or NO	End User Needs Printed Insert?  YES or NO	Can electronic access use a secure login ID and Password? YES or NO
Australia	No	English	No	No	Yes	N/A
Bangladesh	Yes	English	No	No	Yes	Yes
Brazil	No	Portugese	Yes	Yes	No	Yes
China	Yes	Chinese	No	No	Yes	Yes
Chile	No	Spanish	Yes	Yes	No	Yes
Colombia	No	Spanish	No	No	Yes	Yes
Costa Rica	No	Spanish	Yes	Yes	No	Yes
Denmark	No	Danish	Yes	Yes	No	Yes
Greece	No	Greek	Yes	Yes	No	Yes
Hong Kong	Yes	English	No	No	Yes	Yes
India	Yes	English	Yes	Yes	No	Open access
Israel	No	English	Yes	Yes	No	Yes
Japan	No	Japanese	N/A	N/A	Yes	Open access
Jordan	Yes*	English	Yes	Yes	No	Yes
Korea	Yes	Korean	Yes	Yes	No	Yes
Kuwait	No	English	Yes	Yes	No	Yes
Malaysia	Yes	English	Yes	Yes	No	Yes
Mexico	No	Spanish	No	No	Yes	Open access
Mongolia	Yes	English	Yes	Yes	No	Yes
Moldova	No	English	Yes	Yes	Yes*	Yes
Myanmar	No	English	No	No	Yes	N/A
Norway	No	Norwegian	Yes	Yes	No	Yes
Panama	Yes	Spanish	Yes	Yes	No	Yes
Peru	Yes	Spanish	Yes	Yes	No	Open access
Philippines	No	English	No	No	Yes	Yes
Poland	Yes	Polish	Yes	Yes	Yes	Open access
Portugal	No	Portugese	Yes	Yes	Yes	Yes
Salvador	No	Spanish	No	No	Yes	Yes
Singapore	Yes	English	Yes	Yes	Yes	Yes
Taiwan	No	Traditional Chinese	No	No	Yes	N/A
Tanzania	Yes	English	No	No	Yes	N/A
Thailand	Yes	English	Yes*	Yes	Yes	Yes
UAE	Yes*	English	No	No	Yes	Open access
Uruguay	Yes	Spanish	No	No	Yes	No*
Viet Nam	Yes	Vietnamese	No	No	Yes	Yes

------------------------------
Qianqian Zhu RAC
Suwanee GA
United States

Original Message:
Sent: 18-Aug-2021 16:44
From: Charnelle Thomas
Subject: eIFU Globally

Hello,
Does someone have a good resource that identifies where eIFUs are accepted globally for medical devices? I know there is guidance for the US, EU, Australia and Canada, but I wondered if someone has a good resource, webinar or document they have put together to track this globally.

------------------------------
Charnelle Thomas RAC
Director, Regulatory Affairs
Canton GA
United States
------------------------------