Southeast Asia Medical Device Consultants
Southeast Asia medical device consultants
We focus exclusively on regulatory affairs and market access for medical devices and IVDs across Southeast Asia.
We have been representing medical device manufacturers and distributors throughout Southeast Asia since 2013, including startups to medium-sized and multinational enterprises, covering all product risk classes and sectors of the medical device industry.
Our on-the-ground team in Southeast Asia
Our in-house team of local, experienced medical device consultants provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise. Unlike Pacific Bridge Medical or other medical device consultants, we don’t outsource to 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. Our offices are based in:
- Singapore
- Indonesia (Jakarta)
- Malaysia (Penang)
- The Philippines (Las Pinas City)
- Thailand (Bangkok)
- Vietnam (Hanoi and Ho Chi Minh City).
Our regulatory affairs & market access services
- be the in-country representative for your medical devices or IVDs
- register your product
- ensure that the medical device or IVD is correctly labelled
- import your product
- submit change notifications
- ensure post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions.
- maintain communication with appointed distributors
If you are still uncertain about whether your medical device will comply with the regulatory complexities in Southeast Asia, you can request an Intelligence Report for your product.
You can also check out our latest Insights on the different countries and find out more about the local medical device markets and the medical device regulations to register your product.
You can follow us on Linkedin, Twitter and Facebook and sign up for our monthly Regulatory Roundup straight to your inbox.
We look forward to hearing from you!