Malaysia: Globally Leads with New Medical Device Regulatory Reliance Programme (effective from 30 July 2025)

In a world where healthcare innovation often outpaces regulations, one country is stepping forward to bridge that gap with confidence, clarity, and collaboration.

Through a newly launched Medical Device Regulatory Reliance Programme, Malaysia and China are collaborating to expedite access to safe and innovative medical technologies. The programme represents a groundbreaking advancement in international regulatory collaboration, allowing both Malaysia and China to recognise each other’s regulatory decisions for pre-market approvals.

MDA releases the announcement stating that the programme is set to begin officially on 30 July 2025 and will represent something bigger than just shortened timelines. It reflects a mindset shift: from working in silos to working together.

A Smarter Path to Market

For innovators, speed matters. Delays in approvals can cost lives, delay treatments, and discourage new market entries.

So, with this programme:

• Malaysia's in-vitro diagnostic (IVD) devices are now eligible for China’s Green Channel

• Chinese devices can leverage Malaysia’s Verification Pathway

  
  

These mutual recognitions drastically reduce approval timelines to 60 working days for Malaysia and 30 working days for China, resulting in faster delivery of medical technologies to patients.

A Blueprint for the Future

This isn’t just about two countries working together. It’s about setting a precedent for what modern regulatory ecosystems can look like: collaborative, transparent, and future-ready.

By reducing redundant processes and building mutual trust, this initiative aims to:

• Accelerates market access for critical medical devices

• Reduces regulatory duplication, saving companies time and money

• Strengthens Malaysia’s global positioning as a regional regulatory hub in Asia

  
  

This creates ripple effects to boost investor confidence, attracting innovation, and making Malaysia a gateway for MedTech companies across the region.

An Invitation to Innovators

The Medical Device Authority (MDA) and the Ministry of Health Malaysia aren’t keeping this behind closed doors. They’re inviting industry players to get involved, give feedback, and shape how this new model works in real-world settings.

If you’re in MedTech, regulatory affairs, or market strategy, let’s start imagining a future where getting life-saving devices to patients doesn’t have to be a regulatory marathon but a well-mapped partnership.

Source: Medical Device Authority (MDA)