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Philippines: Online Selling Of FDA Certified COVID-19 Self-Administered Test Kits

Philippines, Regulatory updates / By

The Philippines Food and Drug Administration (FDA) issued an advisory, lifting the prohibition of online selling of FDA Certified COVID-19 Test Kits including Self-Administered COVID-19 Test Kits, pursuant to FDA Advisory No. 2022-0107-A Lifting of the FDA Advisory No. 2022-0107 entitled “Reiteration on Prohibition of Online Selling of FDA Certified COVID-19 Test Kits including Self-Administered …

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Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

Regulatory updates, Singapore / By

As ‘smart’ medical devices are commonly used in the health settings with increased connectivity to the cyber world, it’s inevitable to have an increased potential risks of cyber-attacks as well. Thus, at the Singapore International Cyber Week 2022, the Ministry of Health (MOH), Cyber Security Agency of Singapore (CSA), Health Sciences Authority (HSA), and the …

Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD) Read More »

In-vitro diagnostic equipment

Thailand: Collaborative Registration Procedure (CRP) of Thailand FDA – WHO for In-Vitro Diagnostic Products

Regulatory updates, Thailand / By

The Medical Device Control Division, Thai FDA has been recognized by WHO as a reference agency, which allows Thailand to participate in the Collaborative Registration Procedure (CRP) program, that can shorten the duration of registration. The Thai FDA will assess the performance and safety of the medical device in cooperation with the WHO’s evaluation report. …

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Malaysia: MDA Released Second Edition Guidance Documents for Medical Gas System-Requirements for Registration

Malaysia, Regulatory updates / By

Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION. This guidance document will serve as a revised version of MDA/GD/0057 that was released in June 2020, which provides information on the requirements for registration of medical gas system “placed in market” as defined in …

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

Malaysia, Regulatory updates / By

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

Malaysia, Regulatory updates / By

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

Malaysia, Regulatory updates / By

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)

Regulatory updates, Singapore / By

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

Leave a Comment / Malaysia, Regulatory updates / By

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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Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia

Leave a Comment / Indonesia, Regulatory updates / By

On 21 November 2022, the Ministry of Health (MoH) of Indonesia announced that a new development and improvement plan will be applied to the online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the following changes will be applied: Online Submission …

Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia Read More »

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