The MDA has informed the public that they will give transition period until 31 December 2022 to the establishment for compliance with the requirements set out in the guidance document “Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition”. To ensure that the importation and distribution of medical device could
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
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
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
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
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
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