Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact?

S

Smileyk

Hi,

Has anything got an email address for a contact within MFDS that they are willing to share? I'd like to contact an English speaker there by email if possible?

We are considering approving a product in Korea and our prospective distributor is giving us information that I am not convinced is correct.
 
S

Smileyk

My apologies, I of course meant ANYONE. :eek: Although if there are aliens present who can help then I of course wouldn't refuse it. :lol:

Smileyk said:
Hi,

Has anything got an email address for a contact within MFDS that they are willing to share? I'd like to contact an English speaker there by email if possible?

We are considering approving a product in Korea and our prospective distributor is giving us information that I am not convinced is correct.
Click to expand...
 
E

edgar123

Hi,

There are two difficulties in your request.
MFDS agents usually communicate in Korean and a request in English will unlikely be answered.
Second most of information is communicated by phone and they would direct you to the reference document on MFDS website (the Korean version).
I know it's frustrating but that's the way it is.
The only thing I can propose is a second opinion.
Feel free to share either here or in private message.

Thanks
 
J0anne

J0anne

Joanne
Smileyk said:
Hi,

Has anything got an email address for a contact within MFDS that they are willing to share? I'd like to contact an English speaker there by email if possible?

We are considering approving a product in Korea and our prospective distributor is giving us information that I am not convinced is correct.
Click to expand...

Ministry of Food and Drug Safety
Republic of Korea Tel: (+82) 43 719-1564
Fax: (+82) 43-719-1550
[FONT=&quot]Email: [email protected] [/FONT]
 
S

sherniece

Manufacturing Quality
Smileyk said:
Hi,

Has anything got an email address for a contact within MFDS that they are willing to share? I'd like to contact an English speaker there by email if possible?

We are considering approving a product in Korea and our prospective distributor is giving us information that I am not convinced is correct.
Click to expand...
 
S

sherniece

Manufacturing Quality
Hello -HELP!!!! (please) Can someone please provide me with some information regarding Labeling expiration date requirements "shelf life" per country.
Are there any special County Specific Expiration Dates "Shelf Life" for Korea and LATAM? Example _ typically, we do stability studies 36 months and base the shelf life on the 36-month stability study - however, if the county (Korea) have labeling expiration dates (24 months) requirements- then we will have to put 24 months for shelf life since this is county specific. ANY help.guidance, and/or information is appreciated and welcomed. Please provide references to applicable information.......ANY help is apprecated and welcomed.
 
Clueless One

Clueless One

Climbing coporate ladders...by doing nothing.
sherniece said:
if the county (Korea) have labeling expiration dates (24 months) requirements- then we will have to put 24 months for shelf life since this is county specific.
Click to expand...
IIRC, there are no restriction on specific length of expiration dates. Korean medical device safety test standard states that you need accelerated aging test data to justify the length of your expiration date. I could link you to the these standards but theses links are not translated unlike medical device act.
 
S

sherniece

Manufacturing Quality
Thank you- Please link me to these standards including Korea FDA standards regarding the expiration date of the product.
 
Clueless One

Clueless One

Climbing coporate ladders...by doing nothing.
sherniece said:
Thank you- Please link me to these standards including Korea FDA standards regarding the expiration date of the product.
Click to expand...
I don't know if the Korea webpage link will work tho. Here's the link. It's all Korean so you will have to translate for yourself.
shorturl.at/bnHQW
I'm new account so I can't get you a direct link.
 
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