In the interest of consumer protection and to ensure the standardized quality, efficiency, and safety of importing or selling medical devices, the Thai FDA released a draft announcement and guideline on the Quality Management Systems for Importing and Selling Medical Devices on 19 July 2023. Should the final announcement/guideline be
On 27 June 2023, the Ministry of Health (MoH) of Indonesia invited relevant stakeholders to gather input on the Draft Guidelines for Halal Manufacturing Practices for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices. Andaman Medical Indonesia
On 20 July 2023, the Ministry of Health (MoH) Indonesia invited stakeholders to a Socialization of e-Catalogue Opening Submission for Maintenance and Repair Services for Healthcare Facilities via Zoom meeting. Indonesia MoH Bureau of Procurement of Goods and Services announced the opening submission for maintenance and repair services for Healthcare
The Food and Drug Administration (FDA) Philippines has issued draft guidelines to specify the requirements on the use and operation of facilities utilizing Magnetic Resonance Imaging (MRI). In the draft guidelines, all MRI facilities would be required to secure an authorization from FDA through the current rules and regulations on
On July 21, 2023, the Ministry of Health (MoH) issued Circular Letter HK.02.02/E/1289/2023 pertaining to Medical Devices Post Market Testing. In the framework of implementing Government Regulation of the Republic of Indonesia Number 5 Year 2021 (Implementation of Risk-Based Business Licensing), and to ensure that medical device products in circulation
On July 14, 2023, the Medical Device Authority of Malaysia (MDA) announced a transition period of registration with exemption from compliance assessment process by the Compliance Assessment Body (CAB) for the registration of COVID-19 test kits based on Circular Letter Number 2/014. In accordance with Number Circular 2/2014, the evaluation
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