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Independence monument and a cambodian flag at Phnom Penh, Cambodia, on Jun 22th, 2018

Cambodia Medical Device Regulation

Medical devices in Cambodia are regulated by the Department of Drugs and Food (DDF) under the Ministry of Health. The main legislation that specifically regulates medical devices is Prakas No. 1258 (8 November 2012) on the Procedures for the Registration of Medical Devices (hereafter as ‘Prakas 1258’). Prakas is a Cambodian term which means official …

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Malaysia’s Medical Devices Market: US$3.27B Projected Revenue in 2023!

The medical devices market in Malaysia is poised for significant growth, driven by advancements in healthcare infrastructure and increasing healthcare expenditure. With a projected revenue of US$3.27 billion in 2023, the industry is witnessing a dynamic shift, attracting attention from both local and international players. Cardiology Devices Leading the Market Among the various segments within …

Malaysia’s Medical Devices Market: US$3.27B Projected Revenue in 2023! Read More »

COVID-19 home test kits

Transition Period for the Registration of COVID-19 Test Kits with Exemption from Compliance Process by the CAB 

On July 14, 2023, the Medical Device Authority of Malaysia (MDA) announced a transition period of registration with exemption from compliance assessment process by the Compliance Assessment Body (CAB) for the registration of COVID-19 test kits based on Circular Letter Number 2/014. In accordance with Number Circular 2/2014, the evaluation of the COVID-19 test kit …

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Keyboard with EU flag and CE Mark on key

Malaysia: MDA’s Approach to Expired EC Certificates for New Registration and Re-Registration of Medical Devices

The Medical Device Authority of Malaysia (MDA) announced the use of expired EC Certificates for new registration and re-registration of medical devices under certain conditions. This new approach was made due to unpredictable timeline and issues in relation to the transition to the EU MDR and to ensure a continuous supply of medical devices in …

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Person wearing medical gloves holding a COVID-19 test kit

Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS 

The Medical Device Authority of Malaysia (MDA) withdrawn the guidance document MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS from the MDA website on June 8, 2023. The guidance document was initially established and published with the intention to give specific requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the …

Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS  Read More »

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Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs)

The Health Sciences Authority (HSA) of Singapore has been recognized by the World Health Organization (WHO) as a WHO Stringent Regulatory Authority (SRA) for high-risk (Class C and D) in vitro diagnostic medical devices (IVDs). The HSA joins the five founding members (European Union, The United States, Canada, Australia, and Japan) of Global Harmonisation Task …

Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs) Read More »

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Malaysia: MDA Announced Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+

The Medical Device Authority of Malaysia (MDA) announced that enhancements have been made to the MeDC@St 2.0+. For notification module, an improved features have been added to the Clinical Research Use sub-module as follows: The online form has a new look and allows batch uploads on medical device listings. Print Application that allows printing of …

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Drive-by transaction sale

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

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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Cyber security analyst working on a laptop

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

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

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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Rubbed stamp 'revised'

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

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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Folders titled Regulations and Guidelines on a desk

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 …

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

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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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Notepad entitled 'policies update'

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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PCR test with person in full PPE

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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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

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 »

Admin folder for amendments

Malaysia: MDA Issued Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020)

On November 21, 2022, the MDA has announced the release of the Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020). This guidance document is a revision from the Third Edition that was issued in November 2018, to provide the medical device industry a guidance on the categories of changes, the principles of …

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Barcode labels on rolls

MDA Issued Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026)

On November 21, 2022, the MDA has announced the release of the Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026). This guidance document provides minor updates from the Fifth Edition that was issued on 14 June 2022. This document provides guidance to the manufacturers and authorized representatives on the content of medical …

MDA Issued Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026) Read More »

Clinical trial injection bottle and hypodermic needle

Singapore: GN-20: Guidance on Clinical Evaluation Revision 2

The Health Sciences Authority (HSA) Singapore published minor update of guidance document entitled GN-20 R2 Guidance on Clinical Evaluation on 01 November 2022, stipulating clinical investigations carried out by or on behalf of product owner are encouraged and expected to be designed, conducted, and reported in accordance with international ISO 14155 – Clinical Investigation of Medical Devices for …

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A shelf of manilla files

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

The Medical Device Control Division, Thai FDA of the Ministry of Public Health has issued Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, effective 03 December 2022, repealing The Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) B.E. 2563 …

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 Read More »

Updates

Singapore: Minor Update on GN-06: Guidance on Distribution Records

In line with GDPMDS, HSA Singapore also published minor updates of guidance document entitled GN-06 R3 Guidance on Distribution Records on 01 Nov 2022 which assist product owners on the determination of projected useful life of the medical device. Projected useful life of a medical device is dependent on various factors such as technical, legal, …

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New certification

Singapore: GN-33: Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices

Health Sciences Authority (HSA) Singapore has reviewed and validated the medical device guidance document entitled GN-33 R1.2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices Revision 1.2 on 01 Nov 2022 to ensure its accuracy. This guidance document serves to provide advice for application of SS 620: 2016 Singapore Standard …

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Minor update

Singapore: Minor Update on HSA Guidance on Labelling for Medical Devices

The Health Sciences Authority (HSA) Singapore published a minor update to guidance document, GN-32: GUIDANCE on Labelling for Medical Devices Rev 2 (dated September 2022). This update provides alignment to GN-36: Guidance on Medical Device Unique Device Identification (UDI) System mandating the UDI compliance for medical devices in Singapore. The followings are the added points …

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Person carrying out audit and checking paperwork application

Vietnam: Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices

On 12 September 2022, the Vietnamese Ministry of Health issued the QT.TBCT.15 entitled “Procedures for Receiving, Appraising, Issuing, Post-Inspection, and Withdrawing the Circulation Number of The Medical Devices. The regulation applies to the evaluation of all registration routes of medical devices class C and D, and its post inspection with the case of fast-track and …

Vietnam: Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices Read More »

Person using touchscreen app

Malaysia: Guideline for Re-Registration of Registered Medical Device by MDA

On September 15 2022, the MDA has issued second edition of guideline document entitled “Re-Registration of Registered Medical Device” (MDA/GL/08). The following information are added on the guideline: Applicant is not allowed to submit re-registration application concurrently with change notification application; and Requirements on Pre-Market Clearance / Approval All application shall undergo conformity assessment via …

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Person completing forms and admin with a hot drink

Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country

On 27 September 2022, the Philippines FDA issued FDA Circular No. 2022-008 which aims to provide guidelines on the abridged processing of application for registration of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements. This Circular shall apply to Class B, C and D medical …

Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country Read More »

Extended stamp

Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency”

The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration In Light Of The Extended State Of Public Health Emergency” The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration In Light Of The Extended …

Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency” Read More »

Licensing files

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)

On September 23 2022, the MDA has announced the release of the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027). 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 737) and the regulations under it. …

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) Read More »

Monkeypox IVD test

Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA

MDA has released a new guideline document for the registration of Orthopoxvirus (Monkeypox) IVD Test Kits, entitled “Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits” (MDA/GL/09), First Edition” dated September 2022. The guidance document entails the registration requirements, registration process flow, classification, evaluation timeline, application and registration fees of Orthopoxvirus (Monkeypox) IVD Test Kits. …

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