About Us
About Global Rep
Founded in 2019, Global Rep represents foreign medical device manufacturers and supports local establishments in Medical Device Regulatory Affairs. We guide clients in establishing and maintaining systems that comply with ISO 13485 and GDPMD standards. We also provide professional support as an ISO 13485 consultant and GDPMD consultant, helping businesses strengthen compliance and quality management systems.
We achieved GDPMD certification in 2019 and ISO 13485 certification in 2020. We are licensed by the MDA as an authorized representative for medical device, importer, distributor, and manufacturer. Beyond Malaysia, we grow across ASEAN, building strong regional regulatory support.
Our certifications and licenses reflect a strong commitment to compliance and quality, trusted by partners across Malaysia, US, Europe, UK, Japan, China, Taiwan, India, and more.
Our Purpose
To empower foreign medical device manufacturers and local importers & distributors establishments to deliver safe, innovative solutions that help people restore and improve their quality of life.
Vision
To become one of the top 10 regulatory affairs companies in ASEAN by 2035, recognized for excellence, innovation, and trusted partnerships in the medical device industry.
Mission
We bridge global innovation with local expertise by supporting foreign medical device manufacturers, empowering local establishments in regulatory affairs, and building resilient supply chains to drive sustainable growth and improve accessibility.
Years in service
Licensed
Certification
Clients served
Completed projects
Successful project
Team Experience
Yearly sales boost
Core Values
We respect our customers and deeply value their choice to partner with us.
We uphold sincerity, trust, and open communication as the foundation of our business relationships.
We are committed to building sustainable partnerships that create long-term success and mutual growth.
Certification & License
How our roles have evolved
2019
2020
2024
+ Distributor
+ Contract Mfg
2025
2026 >
Achivements & Milestones
- Founded - Feb
- GDPMD certified - Jun
- Appointed as AR - Jun
- Obtained est. license of AR - Jul
- ISO13485 certified - Mar
- Obtained est. license of mfg - May
- Delivered 1st OEM device - Aug
- Obtained est. license of imp.& dist. - Aug
- Delivered 1st contract mfg device - Nov
- Sourcing agency, import & distribute - Oct
- Thailand, Philippines and Indonesia collaborations
- Trademark registration
Regulatory Affairs, ISO 13485 & GDPMD Consultants
Our strategic team comprises seasoned consultants in regulatory affairs, ISO 13485, and GDPMD, bringing diverse industry insights and technical expertise in Malaysia medical device regulations. We provide end-to-end support across the regulatory journey — from registering products with authorities during the pre-market phase, to maintaining registrations by notifying authorities of changes, and assisting with post-market surveillance activities.
In addition, we trains and guides establishments to develop practical quality systems, enhance operational readiness, and adapt to evolving regulatory expectations. Through collaborative planning and hands-on support, we help businesses strengthen compliance and achieve sustainable market success.
Jackie Ng Wei Yeng
Pang Chia Boon
Trusted Regulatory Affairs, ISO 13485 & GDPMD Consultants for Medical Device Compliance
End-to-end compliance support for market access, ISO 13485 & GDPMD system compliance.