Medical Device Market Access Services
We will help you open up new distribution channels whilst you retain independent control of your medical device. We promise you access to new markets with greater ease and flexibility.
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Importation Services
Each country has its own country-specific regulations, requirements and procedures not only for registration but also for the importation of medical devices and IVDs.
Depending on your target country, we will act as your appointed importer as well as your independent marketing authorization holder or local authorized representative (LAR).
In Indonesia, the Philippines, Thailand and Vietnam we will act as both your local authorized representative as well as your principal importer this means we will work with your transporter, customs brokers and the relevant local authorities, to make sure your product gets safely and legally into the country. We don’t simply advise our clients on what to do or which documents to submit, we actually do it, making market access simpler for you.
In Singapore and Malaysia we will act as your local marketing authorization holder or LAR, this means we will authorize your selected importers to import your devices and liaise with them concerning the post-market surveillance of your registered product including the mandatory reporting of Adverse Events and Field Safety Corrective Actions.
Distribution Services
Depending on your target country, we will act as your distributor or master distributor as well as your local marketing authorization holder or LAR. This means you can retain the freedom to appoint as many distributors or sub-distributors for your device as you require, while your product license remains unaffected by any changes in your distributor network.
In Indonesia we will act as your distributor and master distributor which means we will register and import your products. And as your licensed distributor and product license holder, at your request we can list products via the E-Catalogue for distribution to the public healthcare system. And as your master distributor your final distribution channel partners to get your product to the end-user.
In the Philippines, Thailand and Vietnam we will act as your master distributor which means we will register and import your medical devices and work alongside your final distribution channel partners to get your product to the end-user.
The advantage of having a master distributor in Indonesia, the Philippines, Thailand and Vietnam is that you only need to register your medical devices once. This gives you real flexibility in your distribution strategy to nominate as many distributors and sales partners as possible. This means you can adapt quickly to changes in the market by adding new distributors, increasing transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.
In Singapore and Malaysia we will act as your local marketing authorization holder or LAR, this means we will authorize your selected distributors to distribute your devices and liaise with them concerning the post-market surveillance of your registered product including the mandatory reporting of Adverse Events and Field Safety Corrective Actions.