On 29 June 2022, Health Sciences Authority (HSA) Singapore published an update to guidance document, GN-32 GUIDANCE FOR IMPORTATION OF UNREGISTERED MEDICAL DEVICES FOR EXHIBITION IN SINGAPORE Revision 4. Regardless of risk class, unregistered medical devices (human use) for exhibition, are subjected to regulatory controls under the Singapore’s law. Applicants are required to obtain an […]
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
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
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
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
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
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,
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
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
Thailand and Singapore: FDA – HSA Singapore Regulatory Reliance Read More »
Learn about the updates to dental laboratory regulatory requirements, as announced by Health Sciences Authority (HSA) Singapore on 10th May 2021.
Learn about the updates to dental laboratory regulatory requirements, as announced by Health Sciences Authority (HSA) Singapore on 10th May 2021.
Singapore: Dental Laboratory Regulatory Requirements In Singapore Read More »
Malaysia’s Medical Device Authority (MDA) published the 2nd Edition GUIDANCE ON THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES MDA/GD/0009 on 9th May 2022. The document aims to provide clear guidance to manufacturers and establishments on how to determine the classification of medical devices. It also aims to allocate its medical device to an appropriate
Health Sciences Authority (HSA) of Singapore has made minor updates to the guidance document titled ‘GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter Revision 3.6’. This guidance document takes effect on 09 May 2022. It is now a requirement to include the dealer’s contact information to facilitate further information. In addition,
Singapore’s Health Sciences Authority (HSA) Issues New Guidance Read More »
The Health Sciences Authority Singapore published a new guidance document titled ‘Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS). It was published in April 2022. This final version overrides an earlier draft that was sent for industry feedback in 2021. Standalone Medical Mobile Application (SaMD) The
The Health Sciences Authority Singapore has revised a guidance document to strengthen regulatory oversight on cybersecurity as well as facilitate pre-market and/or change application’s required documentation for high-risk SaMDs. The document is titled ‘Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach Revision 2.0’. It is effective from 29 April 2022. The latest
Regulatory Guidelines for Software Medical Devices Read More »
There is new guidance that is effective immediately from the Medical Device Authority (MDA) in Malaysia. It released Appendix 1,5th Revision of Circular Letter of the Medical Device Authority 2 Year 2014 (Appendix 1-Revision 4). This appendix describes the process for conducting conformity assessment by way of verification of the evidence for medical devices that
Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries Read More »
The Philippines Food and Drug Administration (FDA) is asking for input from manufacturers, traders, and distributors (importers/exporters/wholesalers) of IVD Medical Devices (IVDMDs) on the requirements for the Special Certification of new medical technology equipment and devices. All new medical technology equipment and devices to be used for the diagnosis/screening, confirmatory, and monitoring/surveillance of SARS-CoV-2 infection
Malaysia’s Medical Device Authority (MDA) has released draft guidance on 12 April 2022, for labelling registered medical devices. The draft guidelines are open for stakeholder comments until 28 April 2022. This fifth edition introduces the following additions or changes: Location of Labelling General contents of labelling Instructions for use (IFU) Use of specific statements This
On 6 April 2022, Malaysia’s Medical Device Authority (MDA) released draft guidance for change notification on registered medical devices. The draft guidelines are open for stakeholder comments until 20 April 2022. This document provides guidance to determine the correct categories of changes to continue importing, exporting, or placing registered medical devices on the market. This
Malaysia’s Medical Device Authority (MDA) issued a reminder on 5 April 2022 that imported medical devices must be registered and imported by a licensed establishment as provided in sections 5 (1) and 15 (1), Medical Devices Act 2012 (Act 737) or obtain any approval issued by MDA. If you are involved in importing medical devices,
A Reminder That Medical Devices Must be Registered and Imported Correctly Read More »
The Medical Device Authority (MDA) said that based on the definition under section 2 of Act 737, only disinfectants used to disinfect medical devices are categorized as medical devices. Other disinfectant products including body spray disinfectant are not categorized as medical devices and therefore they are not subject to the control of Act 737 enforced
The Medical Device Authority (MDA) decided on 29 March 2022 to replace the requirement of lot-to-lot variation tests. Instead, it’s instituting the approval of a new lot of COVID-19 test kits with the requirement under the post market duties and obligations of the establishment. With this arrangement, the establishment shall inform MDA of any new
MALAYSIA ANNOUNCEMENT ON THE REQUIREMENTS FOR COVID-19 SELF-TEST KITS Read More »
The MDA Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access will be halted. In addition, all future applications will be submitted using the Medcast online system. The deadline for applications pending in CA and SA is set for March 3rd, 2022. All establishments must
REGISTRATION OF COVID-19 IVD TEST KITS IN MALAYSIA Read More »
The Health Sciences Authority Singapore has published updates to the guidance document titled ‘GN-21: Guidance on Change Notification for Registered Medical Devices Revision 4.9’. This guidance document takes effect on 25 April 2022. The main update in this revision is about ‘Change in Design and/or Specifications of General Medical Devices’ where the addition of a
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All Class B, C and D medical devices that are already in the Philippine market prior to the effectivity of FDA Circular 2021-002-A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN shall be extended until 31 March 2023. The Food and Drug Administration (FDA) of The Philippines
First edition guidance on the classification of rehabilitation, physiotherapy, and speech therapy devices was issued by the Ministry of Health Malaysia on 22 April 2022. The Medical Device Authority (MDA) published the guidance document to outline the terms and definitions of rehabilitation, physiotherapy, and speech therapy. This provides manufacturers and authorized representatives a guide to
New Guidance Was Issued For Rehabilitation, Physiotherapy, And Speech Therapy Devices Read More »
The Philippines Food and Drug Administration (FDA) seeks comments from the Medical Device Industry regarding new draft guidelines that could provide faster registration processing and approval should the medical device qualify for the abridged route. Advisory 2021-3084 was issued last November 18, 2021: Abridged Processing of Application for registration/notification of medical devices approved by the
DRAFT FOR COMMENTS: ABRIDGED PROCESSING OF APPLICATION FOR MEDICAL DEVICES Read More »
The purchase of self-test kits for COVID-19 requires providing personal information at sales premises authorized by MDA and KPDNHEP, and the collection of this information is a growing concern among buyers. MDA is aware of the concerns among users and would like to clarify that the requirement to record this personal information is imposed on
Singapore’s Health Sciences Authority published new updates to the guidance document titled ‘Guidance on Special Access Route (SAR) Rev 2’. The announcement is part of HSA’s effort to strengthen regulatory oversight on the importation and local use of unregistered high-risk medical devices requested by qualified practitioners or public healthcare facilities. This guidance document takes effect
Update to Guidance on Special Access Routes (SAR) Takes Effect 1 April, 2022 Read More »
Indonesia’s Minister of Finance, Sri Mulyani, set the VAT rate to increase from 10 percent to 11 percent, effective 1 April 2022. Basic goods and services (rice, meat, public transport, etc.) will continue to be exempted. All transactions apart from basic goods and services as mentioned above will rise to 11% including VAT import and
