Why choose us?
We are regulatory affairs and market access service providers. We specialize in the registration, authorized representation, importation and master distribution of medical devices and in-vitro diagnostics (IVDs) in Southeast Asia.
Andaman Medical is unlike other consulting firms who do not have in-house staff so that they must resort to outsourcing to external regulatory consultants on an ad-hoc project basis. This can lead to poor communication, longer lead times, and lack of regulatory oversight in the long-term.
And with our focus on people and a personalized service, Andaman Medical is distinct from software platforms that simply act as documentary repositories for online registrations without the insight required on how best to navigate the complex regulatory arena particularly in times of increased post-market surveillance (PMS).
What makes us different? At Andaman Medical we provide our clients with:
as to the best registration, market access route and PMS for your medical device or IVD in Southeast Asia thanks to our experienced in-house team of local, on-the-ground regulatory affairs specialists in our six country offices. We don’t outsource.
A true market access service
from registration to ongoing authorized representation for PMS and compliance, from importation including customs clearance through to the (final) distribution of products to the end customer. Unlike other consulting firms, we don’t simply advise our clients on what to do or which documents to upload, we actually do it, so our clients can focus on their core business.
Close collaboration with our local teams
we reply to all client queries within 48 hours. We pride ourselves on open communication, developing personalized, long-term partnerships with our clients. So much so our client retention rate is a fantastic 94% as our clients choose to expand their reach in Southeast Asia by working with us in all the countries we cover.
What’s more, we are ISO 13485:2016 Certified
Andaman Medical received ISO 13485:2016 certification from BSI in November 2021. This certification is a landmark in assuring our clients receive the best quality and service and is the result of implementing a vigorous quality management system which governs our consulting services.
ISO 13485:2016 is an internationally recognized standard of quality and safety for the medical device industry. Andaman Medical has received the certification from BSI, one of the world’s leading standards and inspection organizations showing businesses how to improve performance, reduce risk and achieve sustainable growth.
What makes the difference to our clients? At Andaman Medical we enable our clients to:
- Go-to-market fast and safe in the knowledge their product is fully compliant and stays compliant as unlike platforms crawling the web, we do the legwork of checking regulatory status updates every day to ensure our clients’ products remain compliant. We can do this because we have locally employed, experienced Regulatory Affairs Specialists who speak the local language (as well as having good business English) and have developed relationships with the national authorities responsible for medical devices and IVDs.
- Access real, on-the-ground expertise thanks to our exclusive focus on Southeast Asia: we are physically based throughout Southeast Asia and what’s more our experienced in-house team of Regulatory Affairs Specialists are South Asian.
- Maintain control of their product registrations and gain flexibility in their distribution strategy as we act as the in-country representative meaning clients are unconstrained in the choice of distributor(s).
- Reap the rewards of their market investment more quickly by starting the regulatory process with Andaman Medical whilst having the option to engage our partner company, Maren Medical, in marketing and distribution to the end user. Achieving and maintaining both regulatory and commercial success.
- Concentrate on developing and bringing medical devices to market that improve the health and quality of life for millions as our clients can safely rely on our dedicated team who have registered and represent 900+ 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.