Key Takeaways
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Three pieces of central medtech regulation are underway or in circulation in the Philippines, two of which align with the ASEAN Medical Devices Directive.
The Philippines FDA has issued a new medical devices regulation, which includes the revised requirements for compliance with the ASEAN Medical Devices Directive (AMDD), using the Common Submission Dossier Template (CSDT).
The industry is looking to implement the new rules in early April 2019, when all previously-unregistered devices will need to...