June 2022

obsolete medical equipment

Malaysia’s Medical Device Authority (MDA) Amends Policy for Control over Orphaned, Obsolete and Discontinued Medical Devices

On June 16th 2022, the MDA has announced an amendment to the policy for control of orphaned, obsolete and discontinued medical devices in any facility including hospitals and health facility institutions.   Originally contained in PBPP Circular Letter No. 2 of 2018 (Revision 2) the amendment was passed through the issuance of MDA Circular Letter …

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medical device

Malaysian Medical Device Authority (MDA) Improves the Policy for Control of Medical Device Refurbishment

On June 16th 2022, the MDA announced that the policy for control of medical device refurbishment activities contained in PBPP Circular Letter Number 1 Year 2016 (Revision 2) has been improved through the issuance of MDA Circular Letter Number 3 Year 2022. The improvements to this policy are effective as of May 9th 2022 and …

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covid19 test kit

MDA Announced Exemption of Conformity Assessment Process for the Registration of Covid-19 Test Kit

On June 13th 2022, the MDA has announced the exemption of conformity assessment process for registration of COVID-19 test kits either for personal or professional use via the Circular No.1/ 2022. The approval was decided during the MDA members meeting that was conducted on May 9th 2022. The implementation will be effective on the same …

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ventillator

Philippines Bureau of Internal Revenue have published an updated List of Medical Devices Exempt from VAT

Endorsed by the Food and Drug Administration of the Department of Health, the Philippines Bureau of Internal Revenue has issued the Revenue Memorandum Circular No. 66 – 2022, providing information and guidance to all internal revenue officers, employees and others. This information is related to the letter of Dr. Oscar G. Gutierrez, Jr., OIC-Director General …

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license registration

Enforcement Announcement by Malaysian Medical Device Authority (MDA) Following an Investigation into the Use of Unregistered Medical Devices

Any individual, company or health facility involved in providing medical services must apply for the Medical Device Registration and Establishment License, as defined in Sections 5 and 15 of the Medical Devices Act 2012 (Act 737). An investigation and subsequent results of the compliance monitoring activities conducted by the MDA, found individuals and health facilities …

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Parent using a mercury based thermometer to check their child's temperature

Philippine FDA Has Announced A Notice For Banning Of All Mercury-added Thermometers, Sphygmomanometers, Dental Amalgam Capsules And Liquid Mercury For Use In Dental Restorative Purposes

FDA Circular No.2022-003 MARKETING AUTHORIZATION & DISTRIBUTION/OFFER FOR SALE The Philippine Food and Drug Administration (FDA) has announced a notice to the public regarding the banning of all mercury-added thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes. This Circular aims to totally ban the manufacture, importation, exportation, distribution, sale, …

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Patient having blood test with vacutainer bottles in front

First Edition Guideline Document MDA/Gl/08: Re-Registration Of Registered Medical Device

First edition guidance on the re-registration of registered medical device was issued by the Ministry of Health Malaysia on 3 June 2022. The Medical Device Authority (MDA) published the guidance document to provide information and explanation to the establishment on how to submit re-registration of registered medical device application under Act 737 and MDR 2012 …

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Person using a finger prick blood testing medical device

Thailand FDA – HSA Singapore Regulatory Reliance

The Medical Device Control Division, Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health issued an announcement on the Thailand FDA – HSA Singapore Regulatory Reliance implemented for Class 2-4 IVDs and non-IVDs medical devices effective from 1 June 2022. The registrant in Singapore who obtained the medical device license from …

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