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About Global Rep

Founded in 2019, Global Rep represents foreign medical device manufacturers and supports local establishments in regulatory affairs.

We achieved GDPMD certification in 2019 and ISO 13485 in 2020. We are licensed by the MDA as an authorized representative, importer, distributor, and manufacturer. Beyond Malaysia, we grow across ASEAN, building regional strength.

Our certifications and licenses underscore a steadfast 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.
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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
Authorized Representative
2020
+ Manufacturer
2024
+ Importer & Distributor
2024
+ Contract manufacturer
2025
+ Sourcing agency

Achivements & Milestones

Feb 2019

Founded

Feb 2019
Jun 2019

GDPMD certified

Jun 2019
Jun 2019

Appointed as AR

Jun 2019
Jul 2019

Obtained est. license of AR

Jul 2019
Mar 2020

ISO13485 certified

Mar 2020
May 2020

Obtained est. license of mfg

May 2020
Aug 2020

Delivered 1st OEM device

Aug 2020
Aug 2024

Obtained est. license of imp.& dist.

Aug 2024
Nov 2024

Delivered 1st contract mfg device

Nov 2024
Oct 2025

Sourcing agency, import & distribute

Oct 2025

Strategic Team Members

Jackie Ng Wei Yeng

Jackie holds an LLB and brings extensive experience as a legal advisor and administrative leader in manufacturing. Her expertise in law and corporate management provides a strong foundation for guiding strategy and ensuring regulatory compliance.

Pang Chia Boon

Pang, BSc in Industrial Chemistry, began his career as a chemist before expanding into diverse manufacturing sectors such as plastics, rubber, machining, automation, and orthopaedic devices, where he held executive leadership roles. He later served as a certification body auditor for ISO 9001, ISO 13485, and GDPMD, conducting audits, product conformity assessments, and training industry professionals. With deep expertise in compliance and regulatory affairs, Pang is recognized as a trusted leader in the medical device industry.

Sien Dip Yee

Dip Yee holds a BSc in Food Science with Business Management and began her career in a Food Microbiology Laboratory, where she served as Technical Manager and led the lab to ISO/IEC 17025 accreditation. Building on this foundation, she transitioned into medical device regulatory affairs, gaining training and hands-on experience with industry leaders. Today, she delivers training, develops GDPMD and ISO 13485 systems, and manages medical device registrations with authorities.

Your Partner for Medical Device Compliance

Comprehensive support for certification, licensing, and market entry across Malaysia and the region.

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