About Promaster Integrated Consultancy Sdn Bhd

Your Trusted Partner in Medical Device Compliance

At Promaster Integrated Consultancy Sdn Bhd, we provide comprehensive regulatory consultancy services to help clients navigate and comply with Malaysian Medical Device Regulations, including:

• ISO 13485:2016
• ISO 9001:2015
• GDPMD (Good Distribution Practice for Medical Devices)
• Medical Device Authority (MDA) registration requirements

With deep expertise and a client-focused approach, Promaster is your reliable partner in achieving and maintaining full compliance within the highly regulated medical device industry in Malaysia.

We specialize in a wide range of regulatory and compliance services, including:

• ISO 13485:2016 Certification Support
• GDPMD Compliance Consultation
• MDA Establishment Licensing Application
• Medical Device Registration & Re-Registration (MDA)

Whether you are a new market entrant or an established distributor, Promaster Integrated Consultancy is here to ensure your operations meet the highest regulatory standards—smoothly, efficiently, and confidently.

Let us handle the compliance, so you can focus on what matters most—your business.