HSA Registration Medical Devices
Register your medical device with the HSA Singapore
Andaman Medical is a fully licensed Local Authorized Representative for medical devices in Singapore. We have been representing medical device manufacturers and distributors in Singapore since 2017, 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 Singapore, we will:
- represent your company in all dealings with the HSA and other authorities responsible for medical devices and in-vitro diagnostics
- register your product
- ensure that the medical device or IVD is correctly labelled
- submit change notifications
- add your appointed importers to the MEDICS platform
- 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 Singapore, you can request an Intelligence Report for your product.
You can also check out our latest Insights on the Singapore market and find out more about Singapore’s medical device market.
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We look forward to hearing from you!