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Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018

 
• By Ashley Yeo

The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Flag of Philippines files against a lightly clouded blue sky

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).

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Indian Medtechs Call US Tariffs A Challenge To Growth And Seek Reciprocal Regulatory Access

 
• By Shubham Singh

India’s medical technology industry is raising the alarm over steep new US tariffs on imported medical devices. It argues for structural change to address “unequal regulatory access” and non-tariff barriers.

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Amplitude Acquisition Marks Global Medtech Entry With High Potential In India For Zydus

 
• By Vibha Ravi

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China Strikes Back After Trump Ups Tariffs; Administration Further Delays Tariffs On Canada And Mexico

 
• By Brian Bossetta

In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.

More from Geography

Migraine Relief Without A Pill: Click’s FDA Cleared CT-132 Turns Smartphone Into Therapy Tool

 
• By Shubham Singh

Built on Click’s AI-enabled platform, CT-132 delivers a 12-week behavioral intervention program rooted in multiple evidence-based techniques, including cognitive behavioral therapy (CBT) and bio-behavioral approaches. The goal: reduce brain hypersensitivity and enhance patients’ resilience to migraine triggers.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 
• By Natasha Barrow

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list