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

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 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 and have grown over the last seven years to open six 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 team to register, represent and import their products.

Our values

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 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 industry

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.

Discover why you should choose us

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 regulatory affairs and market access consultancy, 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…:-)

CEO Mourad Kholti

Our growth so far

Our presence

We have local offices throughout Southeast Asia including Singapore, Malaysia, Indonesia, Philippines, Vietnam and Thailand.

Meet our dedicated team of employees

Our team

Meet our dedicated team of employees

Our accreditations

Here you can find some of our professional accreditations and licences as regulatory affairs service providers, together with memberships of professional associations.

Want to know more how we can help you access Southeast Asia?

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