As released on the HSA NEX2US Issue 09 Newsletter (March 2023), Australia’s Therapeutic Goods Administration (TGA) recognized The Health Sciences Authority of Singapore (HSA) as a Comparable Overseas Regulator (COR) with comparable system for the evaluation of medical devices from September 2022. This recognition enables HSA to join the ranks of the other 4 (four) […]
On March 23rd 2023, the MDA announced that they will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days, starting from 1st April 2023. A transitional period will be given to the applicant until May 1st for the full implementation on withdrawal
On February 2023, Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of Product Classification. This guidance document is a revised version of MDA/GL/06 that was released in October 2021,that provides guidance, reference, and clarification on how to apply for Product Classification that are regulated under the Medical Device Act (Act 737).
Malaysia: MDA Released Second Edition Guidance Documents for Product Classification Read More »
On March 9 2023, the MDA has announced the release of the Second Edition Guidance Document “Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device” (MDA/GD/0061). This guidance document was prepared by the Medical Device Authority (MDA) to provide the classification of a list of products used for rehabilitation, physiotherapy, and speech therapy by determining whether
On 03 Mar 2023, the Vietnam Government signed and released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management, which takes effect immediately. Some of the key highlights are mentioned below: Management of medical device prices Listing of prices of medical devices Organizations and individuals manufacturing and trading
FIFTH REVISION OF GN-21: GUIDANCE ON CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICES The Health Sciences Authority (HSA) of Singapore issued a fifth revision of GN-21: Guidance on Change Notification for Registered Medical Devices. This new revised guidance has been made effective starting March 07th 2023. With this revised guidance, it is informed that the Safety
On March 1st 2023, the MDA released the First Edition Guideline Document “Notification of Custom-Made Medical Devices” (MDA/GD/0064). This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016. It also specifies the specific requirements and notification process to obtain permission
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
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
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
On 13 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement to emphasize the requirement for applying renewal of establishment license. The establishments (local manufacturer, authorized representative, distributor, and importer in Malaysia) shall apply for renewal of its establishment license at least 90 days before the expiry date of the licence,
Malaysia: Latest License Terms For Renewal Establishment License By The MDA Read More »
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
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