1. Medtech Insight
  2. >>Geography
  3. >>Asia

Malaysia, Vietnam And Philippines Report Regulatory Compliance Progress And Pain Points

ASEAN member states’ transition to AMDD and certificate renewals are stirring much debate locally

 
• By Ashley Yeo

The latest Asian Regulatory Discussions heard about Malaysia’s five-year device certificate renewal concerns, Vietnam industry’s suggestion for device fast-task approval routes, and the Philippines industry’s transition needs as the country’s new AMDD-based regulatory system gets up and running. Also: device news from Singapore and Thailand.

alamy

The Malaysian ministry of health (MoH)’s Medical Device Authority (MDA) is currently working on several new guidances, including one for manufacturers of rehabilitation and disability products; and another on the circulation in the market of COVID-19 self-tests, which are now allowed to be conditionally approved.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Asia

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
• By Brian Bossetta

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

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.

US FDA Teleconferences In As IMDRF Gathers In Tokyo

 
• By Elizabeth Orr

The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, the agency was able to participate virtually.

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

 
• By Vibha Ravi

Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?

More from Geography

New Semiconductor Tariffs Could Raise Device Costs

 
• By Elizabeth Orr

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 
• By Brian Bossetta

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status

 
• By Natasha Barrow

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.