Register medical devices in Malaysia
How Andaman Medical can help you register your medical device in Malaysia
Andaman Medical is a fully licensed Local Authorized Representative for medical devices in Malaysia. We have been representing medical device manufacturers and distributors in Malaysia since 2014 including startups to medium-sized and multinational enterprises, covering all product risk classes and sectors of the medical device industry.
As your in-country representative for Malaysia, we will:
- represent your company in all dealings with the Malaysian Medical Device Authority and other authorities responsible for medical devices and in-vitro diagnostics
- register your product (standard and special access)
- ensure that the medical device or IVD is correctly labelled
- 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.
If you are still uncertain about whether your medical device will comply with the regulatory complexities in Malaysia, you can request a Regulatory Intelligence Report for your product.
You can also check out our latest Insights on the Malaysian market and find out more about Malaysia’s medical device market.
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!