Change that greatly affect the status of registration of the product or changes requiring a significant amount of work
2016 is here now so Happy New Year first of all ! So in Korea now we are all one year older. Yes, A baby in Korea will not gain one year on his or her birthday. Instead, people will gain one year together on January 1st of every year (New Year’s Day). This is what “Korean age” is.…
KFDA Notification No. 2014-178 2014.10.31 The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical device regulations update on a regular basis. It recently published a notice to inform that several changes would occur and is collecting opinions from the industry. The original publication can be found here (published on Feb. 2, 2015).…
Ministry of Food and Drug Safety Notice No. 2014-155 was published on MFDS website. The Korean Good Manufacturing Practice (KGMP) being revised and this is a public consultation. South Korea medical device registration will be affected by this publication. The purpose here is clearly to improve the way KGMP is managed. Below is a summary…
Korean Ministry of Food and Drug Safety (MFDS) recently released a revision of its reference standard as per Ministry of Food and Drug Safety Notice No. 2014-122 affecting South Korea medical device registration. The purpose is to align with international standards related to electrical and mechanical safety. Are covered the following: radiation safety, usability, alarm…
A notice is given for Limited Revision regarding Medical Device Act 1081; released May 9, 2014 of the South Korea medical device regulations as below: 1. Reasons for Revision A. Subcontracting B. In-Vitro Diagnostic C.License Modification exemption D.Distribution Quality Management Standard E.Periodic Reporting F. Recall Notification The pharmaceutical drugs and the medical devices are currently…
Having visitors is not always a pleasure. On top of that some of them have the right to step in. So it’s better to be prepared for that situation and deal with it no matter what happens. How do you deal with Notified Body Unannounced Audits announced to be taking place soon (if not already)…
May 16, 2014: the list of harmonized standards for the medical devices directive is updated. It’s been more than one year since this list was updated. Last time was Jan. 24, 2014. So what’s the change ? Since it is very hard to figure out just by reading the publication on the Official Journal of…
Here is the Ministry of Food and Drug Safety Notice No. 2014-87 from South Korea. South Korea MFDS is revising 「Regulations regarding Medical Device Products and Product Classification」 (Ministry of Food and Drug Safety Notice No. 2014-88, 2/12/2014) in part, and gathering consensus from the people. They are hereby giving a notice regarding the purpose,…
Finally available. Our translation of the Korean GMP Revision 2 in English is ready. The document was validated and is now ready for review. The main modifications are summarized below: Removed GMP inspection for class 1, but tightened for class 2, in the past, for class 2 only document inspection required, but since Jan 2014 it has been changed to site…
On April 2nd 2014, Ministry of Food and Drug Safety published on their website the second revision of their Korean GMP guideline. The analysis of the changes is currently being made and we will soon be able to provide a gap analysis as well as an English version of the document. Changes include for instance…