Pure Global's Guide to the Philippines' Post-Market Alert System: Mastering AO 2018-0002 for MedTech Success in ASEAN

This episode of ASEAN MedTech Insights provides a deep dive into the mandatory post-market alert system requirements for medical devices in the Philippines, as stipulated by Administrative Order No. 2018-0002. We explore how this regulation aligns the Philippines with the ASEAN Medical Device Directive (AMDD) and what this harmonization means for manufacturers operating across Southeast Asia. We unpack the specific obligations for MedTech companies, detailing the types of adverse events and Field Safety Corrective Actions (FSCAs) that must be reported to the Philippine FDA. The discussion focuses on the critical, non-negotiable reporting timelines that companies must adhere to, and the potential consequences of non-compliance, providing a clear action plan for maintaining market presence. Imagine your company's diagnostic device is on the market in the Philippines and Vietnam. You suddenly discover a component failure that has led to one serious injury in Manila. The clock is now ticking. Do you know the exact deadline to report this to the Philippine FDA to avoid regulatory action? What if the issue also affects patients in Vietnam? Understanding the interconnected ASEAN alert system is no longer optional, it is essential for survival. Key questions answered in this episode: - What specific event triggers a mandatory report under AO 2018-0002? - Are you aware of the different reporting deadlines for a public health threat versus a serious injury? - How does the Philippine Post-Market Alert System connect with other ASEAN countries? - What is a Field Safety Corrective Action and when must you legally initiate one? - Why is a local authorized representative so critical for post-market compliance in the Philippines? - What are the essential documents you need to submit for an adverse event report? - How can non-compliance with these post-market requirements impact your license to operate? Navigating the complexities of post-market surveillance in fast-growing markets like the Philippines requires deep local expertise and a streamlined global strategy. At Pure Global, we combine in-country regulatory experts with advanced AI tools to manage your market access and ensure continuous compliance. Let us handle the regulatory hurdles so you can focus on innovation. Contact us at [email protected] or visit https://pureglobal.com to learn more.

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