Barcode FAQ |
en |
FAQ |
08/2015 |
Guidance for Local Manufacturers |
en |
MDS – G2 |
01/2013 |
Guidance for Medical Device Authorised Representatives |
en |
MDS – G3 |
01/2013 |
Guidance for Medical Devices Importers and Distributors |
en |
MDS – G1 |
01/2013 |
Guidance for Overseas Manufacturers |
en |
MDS – G4 |
01/2013 |
Guidance on Marketing Authorization Procedures |
en |
MDS – G5 |
01/2013 |
Guidance on Medical Devices Bundling/Grouping Criteria |
en |
MDS – G7 |
06/2018 |
Guidance on Post-Marketing Surveilance |
en |
MDS – G6 |
04/2009 |
Implementing Rule On Licensing Of Authorized Representatives |
en |
MDS – IR5 v4 |
07/2018 |
Implementing Rule On Marketing Authorization |
en |
MDS – IR 6 v4 |
07/2018 |
Implementing Rule On Post-Marketing Surveillance |
en |
MDS – IR 7 v2 |
07/2018 |
Implementing Rule on Designation and Oversight of Conformity Assessment Bodies |
en |
MDS – IR1 v2 |
01/2010 |
Implementing Rule on Establishment Licensing |
en |
MDS – IR4 v5 |
07/2018 |
Implementing Rule on Establishment Registration |
en |
MDS – IR2 v4 |
07/2018 |
Implementing Rule on Medical Devices Listing |
en |
MDS – IR3 v5 |
07/2018 |
Implementing Rule on Safeguard Procedures |
en |
MDS-IR8 v2 |
07/2018 |