August Regulatory Affairs Updates
Andaman Medical
Regulatory affairs and market access experts for medical devices in Southeast Asia
Hey there,?
We’re back with your August regulatory updates, and we’ve got some exciting news for you. Stay tuned for the latest changes and key insights in the world of medical regulations across the ASEAN region. Let’s jump in and see what’s new!
Indonesia ????
The Indonesian Ministry of Health is urging medical device companies to update and complete their product data in the Medical Device Dictionary. This effort aims to enhance the regulation and tracking of medical devices within the country. Learn more about the implications and how this affects compliance for manufacturers and distributors.
The Indonesian Ministry of Health is urging businesses and healthcare institutions to submit their data for the Kamus Farmasi dan Alat Kesehatan (KFA), the Pharmacy and Medical Device Dictionary. This initiative is aimed at ensuring accuracy and consistency in medical device and pharmaceutical information nationwide. Learn more about the process and its implications.
The Indonesian government has issued Regulation No. 28 of 2024, which outlines the implementing regulations for Law No. 17 of 2023 concerning health in Indonesia. This regulation provides further guidance on healthcare delivery and governance, aiming to enhance the nation’s health system. Learn more about the details of this important legislation.
The Indonesian Ministry of Health has introduced new guidelines on halal manufacturing methods for drugs, biological products, and medical devices. This regulation also covers the inclusion of halal information on product labels, aiming to ensure compliance with religious standards while maintaining product safety and efficacy. Learn more about the new guidelines.
Thailand ????
The Thailand Food and Drug Association (TFDA) has outlined five important considerations regarding the advertisement of medical devices directly to healthcare professionals that are exempt from authorization. These guidelines aim to ensure ethical promotion and compliance with regulations. Learn more about the key aspects of this notification.
The Thailand Food and Drug Association (TFDA) has provided updated information regarding the registration of diagnostic test kits for Monkeypox. This initiative is part of the country's ongoing efforts to enhance the regulation of medical devices and ensure that diagnostic tests meet international safety and efficacy standards. Learn more about the new registration requirements.
Malaysia?????
The Malaysian Drug Authority and Safety (MDAS) has updated its guidelines regarding expired EC certificates and the self-declaration process for the new registration and re-registration of Class B IVD medical devices. This adjustment aims to streamline regulatory procedures and ensure continued compliance with safety standards. Learn more about these important changes.
Philippines ????
The Philippines Food and Drug Administration (PFDA) has issued guidelines for the pilot implementation of the FDA eServices Portal System, specifically for the initial application of the Certificate of Medical Device Notification (CMDN) within the National Capital Region (NCR). This initiative aims to streamline the registration process and improve regulatory efficiency.?Learn more about the new system.
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Vietnam ????
The Vietnam Ministry of Health (MOH) has released a new draft law on medical devices aimed at improving the regulation, registration, and management of medical devices in the country. This draft law is part of Vietnam's ongoing efforts to align with international standards and ensure safety and efficacy in healthcare products. Learn more about the proposed changes. ?
The Vietnam Ministry of Health has announced updates to the documents concerning the Document Management and Electronic Communication (DMEC) system. These changes aim to streamline processes and enhance efficiency in the management of medical device documentation. Learn more about these important updates. ?
The Vietnam Ministry of Health has released new guidelines for the evaluation of legal documents in the registration dossiers of medical devices in Class C and D. These guidelines aim to streamline the regulatory process and ensure compliance with safety and efficacy standards for higher-risk medical devices. Learn more about the latest regulatory updates.
Key Highlights ?
We had a fantastic time at Philmedical in Manila! ??
It was a pleasure to share our insights and expertise with those exploring opportunities in the Southeast Asian markets. Plus, it’s always thrilling to stay on top of the latest innovations in medical devices and IVDs.
Our Indonesian team came together to celebrate a significant milestone in the nation's history—Indonesia’s Independence Day??? ! Click here to know how the celebrations went!
Reach out to us! ??
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