September 17, 2018
This month’s updates include the "Medical Devices Procurement for Healthcare Institutions ", “Announcement Regarding Registration Application of Medical Devices and Licensed Establishment”, “Exemption from Registration Requirement for Export Only Medical Device” among others. All information you need to know have been summed up in a nutshell.
1) 23rd AHWP Annual Meeting to be held in Malaysia from 22-25 October 2018 - September 2018
The 23rd AHWP Annual Meeting this year will be held at Malaysia International Trade & Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 22-25 October 2018. The meeting is intended to host more intellectual discourses on strategic tracks to accelerate medical device regulatory convergence through promotion of an efficient and effective regulatory model for medical devices.
2) Announcement Regarding Registration Application of Medical Devices and Licensed Establishment under Medical Devices Act 2012 (Act 737) Which Are Still Pending, Following End of Transition Period
MDA has issued a new announcement regarding registration application of medical devices and licensed establishment under Medical Devices Act 2012 (Act 737) which are still pending, following the end of transition period.
3) Circular Letter No.4 Year 2018– Exemption from Registration Requirement for Export Only Medical Device
MDA has issued a revised version of Circular Letter No. 4 Year 2018, whereby it has been decided that export only medical devices will be exempted from medical device registration requirement under Section 5 of Act 737, required to comply with notification requirement with certain charges as may be specified by the Authority, and not allowed to place export-only medical device in Malaysian market.
4) Circular Letter No.4 Year 2014– Medical Device for Import/Export From/To Countries without Diplomatic Ties with Malaysia
According to the recently issued Circular Letter No. 4 Year 2014 (Revision 1), MDA has reiterated that it will not issue an Export Permit or Certificate of Free Sale (CFS) for medical devices to be imported/ exported from/ to countries without diplomatic ties with Malaysia.
5) Circular Letter No.2 Year 2016 –Medical Devices Procurement for Healthcare Institutions
MDA has made some changes in the documentary requirements set for procurement of medical devices in local healthcare institutions, according to recently issued Circular Letter No.2 Year 2016 (Revision 1), to ensure safety and efficiency of the devices.