July 2023

Patient visiting MRI procedure in a hospital

Philippines: Draft Guidelines for Rules and Regulations for Establishment and Operation of Medical Magnetic Resonance Imaging (MRI) Facilities

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 the licensing and registration of […]

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Female Research Scientist Uses Micro Pipette while Working with Test Tubes.

Indonesia: Ministry of Health issued Circular Letter for Medical Devices Post Market Testing

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 meets the requirements of safety,

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COVID-19 home test kits

Transition Period for the Registration of COVID-19 Test Kits with Exemption from Compliance Process by the CAB 

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 of the COVID-19 test kit

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Keyboard with EU flag and CE Mark on key

Malaysia: MDA’s Approach to Expired EC Certificates for New Registration and Re-Registration of Medical Devices

The Medical Device Authority of Malaysia (MDA) announced the use of expired EC Certificates for new registration and re-registration of medical devices under certain conditions. This new approach was made due to unpredictable timeline and issues in relation to the transition to the EU MDR and to ensure a continuous supply of medical devices in

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