Medical Device Distribution Quality Management in South Korea

E

edgar123

#1
Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Are distributors ready ?
After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution more precisely.
This new regulation about medical device distribution will take effect starting from Jan. 1st of next year.

The original publication can be found here (in Korean).
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 1
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
M Prescription medical device distribution licenses in the U.S US Food and Drug Administration (FDA) 3
M US distribution Medical Device Medical Device and FDA Regulations and Standards News 8
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
D Distribution of a Class 3 Medical Device EU Medical Device Regulations 4
M Medical Device Distribution in Canada - Do we need both MDEL and MDL? Canada Medical Device Regulations 14
A Medical Device Distribution in the EU to Patients (End-Users) EU Medical Device Regulations 3
0 Medical Device Distribution Centre and Implementing ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
L MD State License Requirements for Medical Device Distribution Other US Medical Device Regulations 2
M Distribution Center has shipped Sterile Medical Device products that have Expired EU Medical Device Regulations 2
2 Class II Medical Device Distribution Only - Imports into Canada Canada Medical Device Regulations 6
P Internet Medical Device Distribution applied to Internet/Catalog Shops Japan Medical Device Regulations 1
A UK Class I Medical Device Distribution EU Medical Device Regulations 2
M Medical Device Makers - Louisiana Wholesale Drug Distribution Rules Various Other Specifications, Standards, and related Requirements 1
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
A Medical Device including a smartphone - CE mark ? CE Marking (Conformité Européene) / CB Scheme 4
C VOCs as extractable in substance based medical device EU Medical Device Regulations 0
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 5
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
I Medical Device Accessory Responsibility Other Medical Device Related Standards 7
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2

Similar threads

Top Bottom