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FDA Philippines Guidelines: Importation, Distribution Records, and Reporting Obligations for Medical Devices
The Food and Drug Administration (FDA) Philippines has issued a draft guideline for public comments outlining regulatory expectations for medical device establishments regarding record maintenance and post-market reporting. The draft provides structured guidance on importation and distribution records, product complaint handling, adverse event reporting, and field safety corrective actions (FSCAs). This guidance aims to strengthen traceability, post-market surveillance, and
Sharan Murugan
4 minutes ago3 min read
SAHPRA Engagement Portal – Type II Pilot Variation Applications: Submission Window and Fee Processing Clarification
In January 2026, the South African Health Products Regulatory Authority (SAHPRA) issued an important communication to stakeholders regarding Type II variation applications submitted under the Type II Pilot Programme. The update provides clarification on submission window compliance and temporary fee processing arrangements due to a system-related pricing limitation in the SAHPRA Engagement Portal. Background and Context SAHPRA acknowledged that certain applicants experienced
Sharan Murugan
12 minutes ago3 min read
Australia TGA Guidance: UDI for Medical Devices and OTC Medicine Application Requirements
Australia’s Therapeutic Goods Administration (TGA) continues to strengthen regulatory clarity through updated guidance documents covering medical devices and over-the-counter (OTC) medicines. Guidance: Complying with Unique Device Identification requirements for medical devices – TGA The TGA’s guidance on Unique Device Identification (UDI) requirements outlines the regulatory framework for assigning and maintaining UDIs for medical devices supplied in Australia. The UDI sy
Sharan Murugan
23 minutes ago2 min read