January 2023

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Malaysia: MDA Released Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products

On 11 January 2023, the Medical Device Authority (MDA) of Malaysia released the Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products. The revised guideline document covers the following matters : Revision on Changes/Variation to Particulars of a Registered Combination Product. Revision of Post-Marketing Activities: Management of Incident Involving Registered Combination Product […]

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Malaysia: MDA Issued First Edition Guideline Document on How to Submit An Application for Registration of A Refurbished Medical Device

On January 11 2023, the MDA has announced the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10). This guidance document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act

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Philippines: Reiteration Against Unethical Business Practices Related To The Promotion Of Prescription Pharmaceutical Products And Medical Devices (PPPMD)

The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2022-2045 on 29 December 2022, to warn all Prescription Pharmaceutical Products and Medical Devices (PPPMD) companies, and healthcare professionals (HCPs) not to engage in unethical business practices as mentioned in the provisions of Administrative Order (AO) No. 2015-0053 entitled “Implementing Guidelines on the Promotion

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Thailand: Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022

On 09 December 2022, the Thai FDA issued a clarification on the Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, that has become effective on 03 December 2022. With this new regulation, all physical therapy products will be classified as either Class A, B or C medical devices, requiring

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Malaysia: Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices

On 23 December 2022, Malaysia’s Medical Device Authority (MDA) has released a draft guidance document for the requirements of application of certificate of free sale (CFS), manufacturing certificate (MC) and certificate of free sale for export only (CFS EO) medical devices. This draft guidance document will serve as a revised version of MDA/GD/0045 that was

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Malaysia: Keeping up with the Malaysian MDA Latest Regulatory Information and Activities

On 14 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement on how to keep up with the MDA for their latest regulatory information and activities, which also known as Medical Device Authority-Regulatory Information Subscription (MDA-RIS). This program of e-mail notification subscription is an initiative by the MDA, to provide the

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Singapore: Fourth Revision Of GN-35: Guidance On Special Access Routes (SAR)

The Health Sciences Authority (HSA) of Singapore published the 4th Revision of GN-35: Guidance on Special Access Routes (SAR) in January 2023. The major highlighted change of this revised regulation is regarding the stipulated turnaround-time (TAT) of 28 working days for Special Access Route (SAR) application review for specific categories of unregistered Class D medical

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Malaysia: Announcement On Registration Of COVID-19 Test Kits That Have Been Applied Via Conditional Approval And Special Access

On 16 December 2022, the Medical Device Authority (MDA) of Malaysia has published an announcement to emphasize that all Conditional Approval and Special Access for COVID-19 test kits have been halted.  Any future placement of COVID-19 test kits on the Malaysian market shall be subjected to their registration under section 5 of the Medical Device

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