Recognized standards are often used to demonstrate conformity to the Essential Principles of Safety and Performance of Medical Devices. On September 05, 2023, the Health Sciences Authority (HSA) of Singapore published a list of recognized standards for medical devices. This list matches the nationally recognized Singapore Standards (SS) against that
HSA Safety Monitoring and GDPMDS Guidance Documents Update On September 08, 2023, the Health Sciences Authority (HSA) of Singapore published updates to related safety guidance documents as well as GDPMDS document, as follows: • GN-05: Guidance on Reporting of Adverse Events for Medical Devices Revision 3 • GN-07: Guidance on
The Thailand Food and Drug Administration (FDA) announced an amendment to the format of establishment registration certificate for medical device manufacturers and importers. This announcement was in line with the newly issued regulations dated 30 August 2023, as follows: Ministerial Regulation Establishing the Criteria, Procedures, and Conditions for the Registration
The Philippines FDA has issued Advisory No. 2023 – 1881 entitled “Pilot Implementation of the Food and Drug Administration Customer Relation Management Information System (CRMIS) which is an digital platform that will allow stakeholders and general public to submit inquiries, follow – ups, and other concerns via this link http://contact.fda.gov.ph/
Indonesia’s government has officially issued Law No. 17 of 2023 concerning Health which comes into effect on 8 August 2023. At the time this new regulation came into force, the previous Law No. 36 of 2009 concerning Health was revoked and declared invalid. In general, Law No. 17 of 2023
In line with the issuance of Circular Letter No. 1 Year 2023 entitled “Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits,” the Medical Device Authority (MDA) of Malaysia has taken a crucial step by releasing the Guidance Document MDA/GD/0065 entitled “Placement of HIV Self-Test
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