Register medical devices in Indonesia
Register your medical device with the Ministry of Health in Indonesia
Andaman Medical is a fully licensed Local Authorized Representative for medical devices in Indonesia. We have been representing medical device manufacturers and distributors in Indonesia since 2016, 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 Indonesia, we will:
- represent your company in all dealings with the MoH 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
- 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 Indonesia, you can request an Intelligence Report for your product.
You can also check out our latest Insights on the Indonesian market and find out more about Indonesia’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!