Southeast Asia Medical Device Consulting - About Us
Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical devices and in-vitro diagnostics (IVDs) in Southeast Asia.
About Us
Andaman Medical has been a pioneer in regulatory services for medical devices and IVDs since 2013. We operate 8 offices across Southeast Asia, including Singapore, Malaysia, Indonesia, Thailand, the Philippines, Vietnam, and Cambodia. As an extension of Andaman Medical, Nord Pacific Medical operates in Hong Kong, Taiwan, Japan, and Korea, offering closer services to our clients in East Asia.
Our focus is to provide you with a hassle-free experience, allowing you to concentrate on innovating and advancing your medical devices. We ensure the seamless execution of key processes such as:
Medical Device & IVD Registration: Our seasoned in-house team streamlines complex regulatory requirements, offering a one-stop solution for document preparation, submission, follow-up, and approval. This significantly reduces approval timelines while ensuring full compliance and minimizing risks.
Authorized Representative Services: As your dedicated authorized representative, we serve as your trusted liaison with regulatory authorities. Our proactive approach and deep regulatory expertise ensure your interests are protected throughout the process. As an independent license holder, we provide flexibility to work with different distributors, ensuring seamless transitions and full control over your licenses.
Import Solutions: Let us handle the complexities of international trade regulations in the Philippines, Indonesia, and Thailand. As the license holder, we ensure efficient customs clearance and timely delivery, backed by our extensive knowledge of global trade requirements.
Post-Market Compliance Management: We assist with post-market incident reporting, including Field Safety Corrective Actions (FSCAs), mandatory problem reporting, and recalls. We monitor regulatory changes, manage reporting obligations, and implement updates, allowing you to focus on growing your business while maintaining full compliance.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise. We don’t outsource unlike other medical device consulting firms who do not have in-house staff and must contract external consultants on an ad-hoc project basis. This means our clients are reassured that they can safely rely on our dedicated team of employees over the long-term and throughout the region.
Acting as the in-country representative, we prepare, submit and manage device registrations for our clients giving them independence and flexibility over their market access and distribution strategy. And unlike software platforms that simply act as documentary repositories for online registrations, we provide our clients with the ongoing insight on how to navigate the complex regulatory arena particularly at this time of increased post-market surveillance (PMS) and constantly updated compliance requirements.
Leveraging our local expertise and presence, our clients can access markets with even greater ease thanks to our importation and master distribution services. We ensure medical devices obtain customs clearance and are distributed to the end customer, leaving clients to concentrate on their business.
Founded in 2013, we decided to focus exclusively on Southeast Asia medical device consulting and have grown to open seven ASEAN offices in Singapore, Malaysia, Indonesia, Philippines, Vietnam and Thailand. We register, represent and import 1000+ medical devices & IVDs of all classes and all therapeutic areas from ophthalmics to orthopaedics, from cardiovascular to CNS, from diabetes to diagnostics and much, much more.
Our mission
To enable medical device & IVD manufacturers and distributors to concentrate on their core business of developing and bringing medical devices & IVDs to market that improve the health and quality of life for millions. They can do this safe in the knowledge that they can rely on our dedicated Southeast Asia medical device consulting team to register, represent and import their products.
Our values
At Andaman Medical, we live by the principle of ‘Think Global, Act Local.’ Our dedication to excellence is reflected in our thorough knowledge of the local markets we operate in. Driven by the values of integrity, innovation, collaboration and energy, we offer regulatory expertise while building meaningful partnerships within the community.
R for Responsibility
we have a legal, financial, environmental and social obligation to act correctly in respect of applicable local and international law. We are answerable not only to our clients, our colleagues but also to the legal frameworks in place, whilst respecting the environment and promoting social inclusion
I for Integrity
To enable medical device & IVD manufacturers and distributors to concentrate on their core business of developing and bringing medical devices & IVDs to market that improve the health and quality of life for millions. They can do this safe in the knowledge that they can rely on our dedicated Southeast Asia medical device consulting team to register, represent and import their products.
C for Collaboration
We pride ourselves on close collaboration with our local teams through open communication and developing personalized, long-term partnerships with our clients. What’s more we aim to reply to all client queries within 48 hours. So much so our client retention rate is a fantastic 94% as they choose to expand their reach in Southeast Asia by working with us in all of our country offices.
E for Energy
We are a vigourous team always looking to advance and improve what we do for our clients as well as colleagues, whilst maintaining the rigour and gravity required in the regulatory affairs industrym
These values permeate who we are and everything we do at Andaman Medical. RICE as an acronym is also an important symbol throughout Southeast Asia as the source of nourishment, health and life. As we at Andaman Medical aim to help ultimately improve the health and quality of life for millions by helping the healthcare industry get products to market.
And these RICE values are reflected in the dedication of our team in achieving ISO 13485:2016 certification. It embodies our ethos and recognizes that Andaman Medical meets the highest standards of the medical device sector which we serve. With medical device manufacturing being one of the most heavily regulated sectors, we can now demonstrate our commitment to the quality and safety of the medical devices we register and represent throughout Southeast Asia.
About Us
Andaman Medical has been a pioneer in regulatory services for medical devices and IVDs since 2013. We operate 8 offices across Southeast Asia, including Singapore, Malaysia, Indonesia, Thailand, the Philippines, Vietnam, and Cambodia. As an extension of Andaman Medical, Nord Pacific Medical operates in Hong Kong, Taiwan, Japan, and Korea, offering closer services to our clients in East Asia.
Our focus is to provide you with a hassle-free experience, allowing you to concentrate on innovating and advancing your medical devices. We ensure the seamless execution of key processes such as:
- Medical Device & IVD Registration: Our seasoned in-house team streamlines complex regulatory requirements, offering a one-stop solution for document preparation, submission, follow-up, and approval. This significantly reduces approval timelines while ensuring full compliance and minimizing risks.
- Authorized Representative Services: As your dedicated authorized representative, we serve as your trusted liaison with regulatory authorities. Our proactive approach and deep regulatory expertise ensure your interests are protected throughout the process. As an independent license holder, we provide flexibility to work with different distributors, ensuring seamless transitions and full control over your licenses.
- Import Solutions: Let us handle the complexities of international trade regulations in the Philippines, Indonesia, and Thailand. As the license holder, we ensure efficient customs clearance and timely delivery, backed by our extensive knowledge of global trade requirements.
- Post-Market Compliance Management: We assist with post-market incident reporting, including Field Safety Corrective Actions (FSCAs), mandatory problem reporting, and recalls. We monitor regulatory changes, manage reporting obligations, and implement updates, allowing you to focus on growing your business while maintaining full compliance.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise. We don’t outsource unlike other medical device consulting firms who do not have in-house staff and must contract external consultants on an ad-hoc project basis. This means our clients are reassured that they can safely rely on our dedicated team of employees over the long-term and throughout the region.
Acting as the in-country representative, we prepare, submit and manage device registrations for our clients giving them independence and flexibility over their market access and distribution strategy. And unlike software platforms that simply act as documentary repositories for online registrations, we provide our clients with the ongoing insight on how to navigate the complex regulatory arena particularly at this time of increased post-market surveillance (PMS) and constantly updated compliance requirements.
Leveraging our local expertise and presence, our clients can access markets with even greater ease thanks to our importation and master distribution services. We ensure medical devices obtain customs clearance and are distributed to the end customer, leaving clients to concentrate on their business.
Founded in 2013, we decided to focus exclusively on Southeast Asia medical device consulting and have grown to open seven ASEAN offices in Singapore, Malaysia, Indonesia, Philippines, Vietnam and Thailand. We register, represent and import 1000+ medical devices & IVDs of all classes and all therapeutic areas from ophthalmics to orthopaedics, from cardiovascular to CNS, from diabetes to diagnostics and much, much more.
Our mission
To enable medical device & IVD manufacturers and distributors to concentrate on their core business of developing and bringing medical devices & IVDs to market that improve the health and quality of life for millions. They can do this safe in the knowledge that they can rely on our dedicated Southeast Asia medical device consulting team to register, represent and import their products.
Our values
At Andaman Medical, we live by the principle of ‘Think Global, Act Local.’ Our dedication to excellence is reflected in our thorough knowledge of the local markets we operate in. Driven by the values of integrity, innovation, collaboration and energy, we offer regulatory expertise while building meaningful partnerships within the community.
Responsibility
Take ownership, however it’s ok to make mistakes!
Integrity
Act honestly and have strong moral principles
Collaboration
Work together and support group/organisational objectives
Energy
Bring a level of enthusiasm and willingness to your work
Discover why you should choose us
Our Journey: From Humble Beginnings to Regional Leadership
Our momentum continued in 2017 with further expansion into Thailand and Vietnam, reflecting our dedication to meeting the needs of our clients across Southeast Asia. In 2021, we achieved a significant milestone by receiving ISO 13485:2016 certification from BSI, underscoring our commitment to quality and regulatory compliance.
In 2022, we extended our reach to Cambodia, and in 2023, we established Nord Pacific Medical in Hong Kong, further broadening our footprint. Our growth journey continued in 2024 with expansions into Taiwan, Japan, and Korea, bringing us closer to our clients in East Asia and enhancing our ability to provide localized support.
Today, Andaman Medical stands as a testament to our unwavering dedication to the medical device industry. Our story is one of continuous growth, driven by a passion for excellence and a commitment to supporting our clients’ success in an ever-evolving regulatory landscape.
Our Milestones
Andaman Medical has been a pioneer in regulatory services for medical devices and IVDs since 2013. We operate 8 offices across Southeast Asia, including Singapore, Malaysia, Indonesia, Thailand, the Philippines, Vietnam, and Cambodia.
As we expand our footprint, Nord Pacific Medical is established in Hong Kong, Taiwan, Japan, and Korea, offering closer services to our clients in East Asia.
Our story / founder
Mourad Kholti, a French national, moved to Malaysia in 2011 and started working as RAQA manager for a subsidiary of Teleflex, a global medical device manufacturer. Witnessing new regulations being implemented for medical devices and IVDs at that time, Mourad seized the opportunity to launch his own Southeast Asia medical device consulting company, Andaman Medical in 2013.
Mourad regularly visits his family and friends back in Europe. Locally he has set up and runs a local football team, the Penang International Football School. He speaks French, English, Italian, some Arabic and currently learning Bahasa Malaysia…:-)
Our growth so far
Andaman Medical is launched in Malaysia
Andaman Medical expands and creates a new office in Singapore which will act as the corporate head office going forward
Sees the launch of two new offices in Indonesia and the Philippines respectively as a testament to the growing demand in medical device & IVD markets in ASEAN
Just one year later sees further expansion into Thailand and Vietnam respectively
Andaman Medical receives ISO 13485:2016 certification from BSI
Our presence
We have local offices throughout Southeast Asia including Singapore, Malaysia, Indonesia, Philippines, Vietnam and Thailand.
Our accreditations
Here you can find some of our professional accreditations and licences as regulatory affairs service providers, together with memberships of professional associations.
MALAYSIA
SINGAPORE
INDONESIA
PHILIPPINES CORPORATION
THAILAND
VIETNAM COMPANY LIMITED
CAMBODIA COMPANY LIMITED
MALAYSIA
ISO 13485 Certificate_Andaman Medical Malaysia & Singapore_Valid until 29 Nov 2027
Quality Management System: Good Distribution Practice for Medical Devices (GDPMD)
Establishment License as Authorized Representative from Medical Device Authority (MDA) 2024
Andaman Medical Malaysia Membership Malaysian Chamber of Commerce
SINGAPORE
Establishment License as Authorized Representative from Health Science Authority. ©
Certificate of Incorporation-Andaman Medical Pte Ltd
ISO 13485 Certificate_Andaman Medical Malaysia & Singapore_Valid until 29 Nov 2027
INDONESIA
Andaman Medical is a member of Association of Medical Device and Laboratory Equipment Company Organizations (GAKESLAB = Gabungan Perusahaan Alat-alat Kesehatan dan Laboratorium)
NIB
SIUP (Business License)
Medical Device Distributor License (IDAK)_Andaman Medical Indonesia
GDPMD Certificate_Andaman Medical Indonesia
PHILIPPINES CORPORATION
FDA License to Operate as Medical Device Importer/Distributor
THAILAND
Establishment registration certificate (License to Operate) as Medical Device Importer from Thai FDA
VIETNAM COMPANY LIMITED
Andaman Medical Vietnam Business License
Andaman Medical Vietnam Representative Office License
Declarations of eligibility for trading medical devices class B, C, D
Andaman Medical Vietnam Investment License
CAMBODIA COMPANY LIMITED
MoH License_Andaman Medical Cambodia
Certificate of Incorporation_Andaman Medical Cambodia
Certified Excellence
At Andaman Medical, we pride ourselves on achieving the highest standards of quality and compliance. Our ISO 13485:2016 and GDPMD certifications reflect our unwavering commitment to excellence in regulatory affairs and market access. Each certification underscores our dedication to providing reliable, top-tier services that meet and exceed industry standards. Trust in our certified excellence to guide your products through the complex regulatory landscape with confidence.
At Andaman Medical, we pride ourselves on achieving the highest standards of quality and compliance. Our certifications and accreditations reflect our unwavering commitment to excellence in regulatory affairs and market access. Each certification underscores our dedication to providing reliable, top-tier services that meet and exceed industry standards. Trust in our certified excellence to guide your products through the complex regulatory landscape with confidence.
MALAYSIA
SINGAPORE
INDONESIA
PHILIPPINES CORPORATION
THAILAND
VIETNAM COMPANY LIMITED
CAMBODIA COMPANY LIMITED
MALAYSIA
ISO 13485 Certificate_Andaman Medical Malaysia & Singapore_Valid until 29 Nov 2027
Quality Management System: Good Distribution Practice for Medical Devices (GDPMD)
Establishment License as Authorized Representative from Medical Device Authority (MDA) 2024
Andaman Medical Malaysia Membership Malaysian Chamber of Commerce
SINGAPORE
Establishment License as Authorized Representative from Health Science Authority. ©
Certificate of Incorporation-Andaman Medical Pte Ltd
ISO 13485 Certificate_Andaman Medical Malaysia & Singapore_Valid until 29 Nov 2027
INDONESIA
Andaman Medical is a member of Association of Medical Device and Laboratory Equipment Company Organizations (GAKESLAB = Gabungan Perusahaan Alat-alat Kesehatan dan Laboratorium)
NIB
SIUP (Business License)
Medical Device Distributor License (IDAK)_Andaman Medical Indonesia
GDPMD Certificate_Andaman Medical Indonesia
PHILIPPINES CORPORATION
FDA License to Operate as Medical Device Importer/Distributor
THAILAND
Establishment registration certificate (License to Operate) as Medical Device Importer from Thai FDA
VIETNAM COMPANY LIMITED
Andaman Medical Vietnam Business License
Andaman Medical Vietnam Representative Office License
Declarations of eligibility for trading medical devices class B, C, D
Andaman Medical Vietnam Investment License
CAMBODIA COMPANY LIMITED
MoH License_Andaman Medical Cambodia
Certificate of Incorporation_Andaman Medical Cambodia
