Great News for Medical Device Companies in Malaysia!
The Malaysian government has launched a new, expedited approval process for establishment license applications. Complete applications will now be processed within just 14-21 working days!
📝 Key documentation required includes:
1. An updated Letter of Authorization (LOA) with precise address details in the specified format.
2. An updated list of medical devices on Attachment 1.
3. Confirmation that the Person Responsible is listed among the directors in Form 49, or an appointment letter for the Person Responsible signed by a Director from Form 49 and appointed by top management.
4. An updated Quality Management System (QMS) report alongside a valid certificate.
5. A QMS report prepared by a registered Conformity Assessment Body (CAB).
Find out more: https://lnkd.in/e3aMrYfR
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