Malaysia: MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN September 12, 2022
Singapore: Minor Update To Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore September 9, 2022
Malaysia: Enforcement Activities Carried Out By The MDA During The Participation In The Pangea XV 2022 Operation August 24, 2022
Vietnam: Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases August 12, 2022
Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices August 10, 2022
Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue August 10, 2022
Singapore: HSA Released Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs) July 18, 2022
Philippines: FDA Released An Amendment To FDA Circular No. 2017-013, Entitled, “Guidelines On The Issuance Of Clearance For Customs Release (CFCR) Of Radiation Devices By The Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR) July 18, 2022
Philippines: Reminder on the Submission of Financial Reports through the FDA Online Disclosure Reporting System July 15, 2022
Malaysia: Full Enforcement Announcement of Medical Device Regulations (Responsibility & Establishment) 2019 July 11, 2022
Malaysia: Medical Device Authority Releases Fifth Edition of Requirements for Labelling of Medical Devices July 11, 2022
Malaysia: MDA Provides Transition Period For Compliance With The Requirements Of Labelling Of The Medical Devices (MDA/GD/0026, Fifth Edition) July 6, 2022
Singapore: Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore July 6, 2022
