Apple Watch ECG Feature Likely Coming Soon to South Korea

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Original poster
Apr 12, 2001
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Apple has included an ECG function in new Apple Watch models since 2018, providing users in select territories with the ability to measure the electrical activity of their heart. Apple now appears to be ready to extend the ECG feature to South Korea, based on recent government filings.


According to etnews, Apple has obtained an approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its ECG app. Apple will likely issue an update to ‌Apple Watch‌ users in the country to enable the electrocardiogram feature and irregular heart notifications on their devices, since the company has now completed every prerequisite for a Korean version.

Apple routinely has to gain approval from government health agencies before marketing the ‌Apple Watch‌'s ECG feature in different countries. Apple won U.S. FDA clearance to promote the function when the ‌Apple Watch‌ Series 4 launched in 2018.

In May, Japan and Brazil gained approval for ECG functionality and irregular heart rhythm notifications on Apple Watch, but it appears as though users in those countries are still waiting for the features to be enabled.

Article Link: Apple Watch ECG Feature Likely Coming Soon to South Korea
 

Jarman74

macrumors regular
Mar 22, 2009
163
316
For South Koreans this is a welcome feature that will ease the pain of dealing with their northern neighbor's shenaningans.
 
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davidec

macrumors 6502
Jan 31, 2008
353
324
And yet here in Australia they market this feature in TV ads and that feature is not available 😒
And not sure whom to believe but I got this response back today which sadly appears to imply Apple have yet to lodge an application. Something extremely off here in oz:

”If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the Australian Register of Therapeutic Goods (ARTG) in order to be legally supplied in Australia. The TGA is unable to compel a sponsor to submit an application to register a product and approval for marketing in Australia cannot be given in the absence of an application.

Sponsors must apply to the TGA for their medical devices to be included in the ARTG. As the minimum requirement, sponsors must have evidence that the manufacturer has applied appropriate conformity assessment procedures to their product. The sponsor also must have evidence that their medical device complies with the requirements for essential principles of safety and performance.

Due to confidentiality the TGA does not disclose information about current applications, and cannot advise whether an application has been received or is in progress. The information that the TGA can lawfully provide about a product is publicly available on the TGA website.

You may wish to contact the sponsor or manufacturer for further information about their intentions to submit an application to the TGA for registration of this product”
 
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alien3dx

macrumors 65816
Feb 12, 2017
1,207
244
It's cool that another country gets the feature. Apple pls... file for Australians.
it's not perfect tool for diagnose and i always get "cannot read/ understand". Mine also don't have but some colig have paid xxx something to enable it.. It may be ilegal way but i need to test it because i have heart issue pretty small but still data for me.
 

AussieStu

macrumors member
Feb 28, 2006
44
32
And yet here in Australia they market this feature in TV ads and that feature is not available 😒


Interesting enough I asked this question... here is the reply i got.


Good afternoon

Thank you for your enquiry of 31/07/2020 to the Therapeutic Goods Administration (TGA).


Unless exempt or otherwise authorised by the TGA, therapeutic goods lawfully supplied in Australia must appear as an entry in the Australian Register of Therapeutic Goods (ARTG).


To gain approval to supply a therapeutic product in Australia, the sponsor of that product would need to submit an application together with supporting data to the TGA for evaluation. The TGA is unable to compel a sponsor to submit an application to register a product and approval for marketing in Australia cannot be given in the absence of an application.


Due to confidentiality the TGA does not disclose information about current applications, and cannot advise whether an application has been received or is in progress. The information that the TGA can lawfully provide about a product is publicly available on the TGA website.


You may wish to contact the sponsor or manufacturer for further information about their intentions to submit an application to the TGA for registration of this product.
For more information about the TGA, please refer to the short video on the Role of the TGA.


Yours sincerely

Steven

Regulatory Assistance Service
Regulatory Guidance, Assistance and SME Section

Regulatory Engagement, Education and Planning Branch

Phone: 1800 020 653 Fax: 02 6203 1605
Email: info@tga.gov.au

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia
 

AussieStu

macrumors member
Feb 28, 2006
44
32
And not sure whom to believe but I got this response back today which sadly appears to imply Apple have yet to lodge an application. Something extremely off here in oz:

”If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the Australian Register of Therapeutic Goods (ARTG) in order to be legally supplied in Australia. The TGA is unable to compel a sponsor to submit an application to register a product and approval for marketing in Australia cannot be given in the absence of an application.

Sponsors must apply to the TGA for their medical devices to be included in the ARTG. As the minimum requirement, sponsors must have evidence that the manufacturer has applied appropriate conformity assessment procedures to their product. The sponsor also must have evidence that their medical device complies with the requirements for essential principles of safety and performance.

Due to confidentiality the TGA does not disclose information about current applications, and cannot advise whether an application has been received or is in progress. The information that the TGA can lawfully provide about a product is publicly available on the TGA website.

You may wish to contact the sponsor or manufacturer for further information about their intentions to submit an application to the TGA for registration of this product”




I got something the same..
Good afternoon

Thank you for your enquiry of 31/07/2020 to the Therapeutic Goods Administration (TGA).


Unless exempt or otherwise authorised by the TGA, therapeutic goods lawfully supplied in Australia must appear as an entry in the Australian Register of Therapeutic Goods (ARTG).


To gain approval to supply a therapeutic product in Australia, the sponsor of that product would need to submit an application together with supporting data to the TGA for evaluation. The TGA is unable to compel a sponsor to submit an application to register a product and approval for marketing in Australia cannot be given in the absence of an application.


Due to confidentiality the TGA does not disclose information about current applications, and cannot advise whether an application has been received or is in progress. The information that the TGA can lawfully provide about a product is publicly available on the TGA website.


You may wish to contact the sponsor or manufacturer for further information about their intentions to submit an application to the TGA for registration of this product.
For more information about the TGA, please refer to the short video on the Role of the TGA.


Yours sincerely

Steven

Regulatory Assistance Service
Regulatory Guidance, Assistance and SME Section

Regulatory Engagement, Education and Planning Branch

Phone: 1800 020 653 Fax: 02 6203 1605
Email: info@tga.gov.au

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia
 

niji

Contributor
Feb 9, 2003
1,853
1,981
hokkaido
approval in South Korea bodes well that Japan's delay in actually getting it on Watches sold in Japan is only a matter of a marketing timing, waiting until the next Watch is released.
 
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