Regulatory & Market Access Partner
Your Independent
Local Authorized Representative
for Medical Devices
Unlocking Market Access, Enabling Business Growth
Trusted Medical Device Regulatory Affairs Partner for Regulatory Success
Founded in 2019, Global Rep serves as a trusted partner for foreign medical device manufacturers and local establishments, guiding them through the complex medical device regulatory affairs landscape. With GDPMD certification and ISO 13485 certification, and licensing from the Medical Device Authority (MDA), we ensure full compliance, quality assurance, and seamless medical device regulatory affairs processes. Our presence extends across ASEAN countries, supporting an international client base from the US, Europe, UK, Japan, China, Taiwan, India, and more.
We’re ambitious to grow — expanding our medical device regulatory affairs services to reach more ASEAN countries by 2030, while maintaining our commitment to compliance, quality, and client satisfaction.
Independent Authorized Representative
As an authorized representative for medical device, we secure regulatory approvals and build a reliable supply chain for seamless market access.
Medical Device Registration
We provide end-to-end support to ensure a smooth and hassle-free medical device registration process, enabling you to bring your products to market quickly while maintaining full compliance.
System & Regulatory Compliance
We make market entry simple—managing GDPMD, ISO 13485, licensing, and registration while you drive innovation.
Regulatory Notifications
Seeking special access to expand your business? Planning to update your medical device registration to legalize new offerings? Let us secure the necessary approvals on your behalf.
Sourcing, Importation & Distribution
From sourcing to delivery, we ensure precision, timeliness, and the confidence your business deserves.
Fun Facts
Discover some eye-opening facts about how we handle medical device regulatory affairs:
Independent Representation
We manage your medical device registration while keeping you flexible to capture market opportunities.
Reliable Expertise
We apply strong expertise throughout the process to achieve your business goals reliably.
Connecting Across Languages
We speak your language and transform your plans into work well done.
Local Market Presence
We stay on the ground to streamline communication with authorities and stakeholders.
Licensed & Dependable
We are fully accredited and provide dependable Medical Device Regulatory Affairs support.
Regulatory Vigilance
We track regulatory updates closely to keep your compliance secure and up to date.
Innovation Forward
We stay ahead of market shifts to identify opportunities and support growth initiatives.
Globally Trusted
We are proud to have testimonials highlighting our reliable, consistent, and dependable results.
Malaysia MDA-Licensed Establishment
Authorized Representative | Importer | Distributor | Manufacturer
Global Rep provides an integrated pathway for medical device manufacturers looking to enter Malaysia and expand across ASEAN. We help you start, enter, grow and expand—from regulatory strategy and device classification to registration, local representation, post-market compliance and multi-market regulatory coordination. With Malaysia as your starting point, we help turn regulatory requirements into a practical roadmap for sustainable regional market growth.
Our Clients Speak Out
Global Rep has been such a reliable partner for us at Innervate Tech. They’ve handled some really important projects with care and delivered everything on time—and the results have been fantastic. Working with their team has been a smooth and positive experience, and we’re excited to keep building our partnership and growing together.
On behalf of Changzhou Nanxiang Medical Device Co., Ltd. (NX Medical), I would like to extend our heartfelt appreciation for your invaluable assistance in the registration process of our Class III medical device in Malaysia, as well as for acting as the License Holder on our behalf.
Throughout our collaboration, we have been consistently impressed by the high level of professionalism and expertise your team demonstrated. Your deep understanding of Malaysian medical device regulations and the registration pathway provided us with clear, compliant, and efficient solutions.
We also greatly value your prompt and effective communication. Your team was always responsive, proactive in providing updates, and ensured that any queries or issues were addressed swiftly....
This transparent and reliable communication was crucial in keeping the project on track and building a strong partnership.
Furthermore, we found your servicing fee structure is fair, reasonable, and reflective of true value. The quality of service and the results delivered have made this collaboration highly cost-effective for us.
Your support has been instrumental in successfully navigating the complex regulatory landscape in Malaysia and has played a key role in our market entry strategy. We truly appreciate the trust and responsibility you have undertaken by holding the registration certificates for us.
We look forward to the possibility of future collaboration and sincerely thank you once again for your dedication, expertise, and partnership.
Global Rep have been invaluable partners in navigating the complexities of the Malaysian medical device licensing landscape. Acting as a true extension of our company, Mr. Pang provided candid, practical guidance that was always aligned with our best interests, with minimal guesswork required on our side. His patience, clarity and hands-on support in tailoring the regulatory approach to our actual situation made the entire process remarkably smooth and effective, and the final outcome exceeded our expectations in every way.
Your company demonstrated a high level of professionalism in all business interactions. Communication was clear, respectful, and prompt throughout the process. Orders were handled efficiently, with accurate processing and timely delivery. The person-in-charge was responsive and supportive when questions or concerns arose. The sales person was very knowledgeable and helpful in explaining medical products and their proper use.
The medical products were of high quality and met industry standards. Pricing was fair and reflected the quality and reliability of the medical products. Product information, certifications, and safety guidelines were clearly provided.The company showed strong compliance with healthcare regulations and safety requirements.
Overall, the experience of doing business with Global Rep Sdn Bhd was very positive and trustworthy.
We have been collaborating with you since years ago (product registration) and now further with some additional wires and drill bits. We are pleased with collaborating with you and partnership with you. Things are simple and fast in corresponding and also inquiry. Speed and fast response is no doubt. All in all (nutshell) we would be continuing to collaborate with Global Rep in years to come.
Since becoming BNS's Authorized Representative in Malaysia in 2019, Global Rep has consistently demonstrated the highest level of professionalism and dedication. With your strong support, we have successfully obtained two key medical device registrations, laying a solid foundation for our operations. Your work in appointing importers and distributors has also been excellent, ensuring the smooth entry of our products into the local market.
We especially appreciate your ongoing and patient guidance regarding regulatory compliance. Your team has always been responsive, thorough, and professional, making complex requirements much clearer for us.
A special thanks to Mr. Pang and his team—your local expertise, proactive communication, and deep understanding of our goals have been instrumental in the successful expansion of BNS in Malaysia.
We look forward to continuing our partnership and achieving more success together. Sincere thanks to the entire Global Rep team!
Our experience working with Global Rep has been very positive. Your team consistently delivers fast, reliable, and helpful service, and the level of professionalism has been greatly appreciated.
A very professional partner to work with. Good understandings on the Medical Device Regulations in Malaysia and capable of providing practical and useful advice to foreign manufacturers. Very responsive to enquiries regardless of the time difference. Proactive in providing progress updates. Overall, I would recommend Global Rep as an Authorized Representative for medical devices.
Working with Global Rep has been a truly positive experience. Their team consistently provides clear answers to our queries and guide to delivering results on all our applications. Looking forward to continued success together.
Global Rep Sdn Bhd is run by an honest and reliable team that delivers exactly what they promise. They are very responsive, professional, and easy to work with, making the entire process smooth and worry-free. You can trust them to handle matters properly and transparently. The impact of their help has been truly life-changing for me. With their tip-top service and consistent follow-through, you can rest assured you are in good hands.
Global Rep is a professional and reliable partner for our organization. In our first collaboration, we successfully obtained a Class C medical device registration in Malaysia via the full conformity assessment route in just about three months – with great efficiency. From pre‑project guidance to daily execution, their team provided detailed, professional, and rigorous support, kept us informed of every update, and proactively drove the process forward until final approval. We truly appreciate Global Rep for their professional support and pleasant collaboration. We look forward to continuing our partnership and achieving more together.
Trusted by Medical Device Companies Worldwide
Navigating Every Stage of Medical Device Regulatory Affairs with Confidence
Comprehensive support for certification, licensing, and seamless market entry across Malaysia and the region.
Global Rep is an exceptionally valuable and strategic partner for our organization. With their support, we successfully and efficiently completed the registration of our medical devices in Malaysia. The collaboration was characterized by a high level of professionalism, strong structure, and outstanding productivity. We particularly value their deep expertise, reliability, clear communication, and consistently supportive and approachable team. We highly recommend working with Mr. Pang Chia Boon and his team.