Mandatory Problem Reporting Form
Please download the “Mandatory Problem Reporting Form” on below link. Mandatory Problem Reporting Form.pdf
Read morePlease download the “Mandatory Problem Reporting Form” on below link. Mandatory Problem Reporting Form.pdf
Read morePlease download the “Declaration of Product Safety Format” on below link. Declaration-of-Product-Safety-Format
Read moreCover Letter Letter of authorization from owner or manufacturer Product description Manufacturing license or GMP certificate copy/ EC certificate ISO
Read moreCover Letter Letter of Authorization from owner or manufacturer Product Description (If necessary) Manufacturing License/ GMP Certificate/ EC certificate ISO
Read moreCover Letter Letter of Authorization from owner or manufacturer Product Description (If necessary) Manufacturing License or GMP Certificate Copy ISO
Read moreDownload “LOA format”
Read moreDownload “TEMPLATE FOR DECLARATION OF CONFORMITY”
Read moreLink of ASEAN Medical Device Directive(AMDD) https://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
Read moreA Guideline on Notification of Cosmetic Product Application, issued in February 2009. Download
Read more