Indonesia is the third country to implement the AMDD standard, following Singapore and Malaysia.
Indonesia is classified into Class A, Class B, Class C, and Class D according to risk, and product groups are broadly classified into five categories.
· Radiation electromedical devices
· Non-radiation electromedical devices
· Sterile non-electromedical devices
· Non-sterile non-electromedical devices
· In vitro diagnostic medical devices
Also, if you want to import or sell medical devices in Indonesia,
After obtaining Medical Device Distributor License from KEMENTERIAN KESEHATAN REPUBLIK INDONESIA (Ministry of Health Republic of Indonesia), you need to apply for Product licenses and get it issued.
Product licenses are valid for up to 5 years, and applications for registration renewal must be made 6 months in advance.
The documents to be submitted when applying for product license registration are as follows.
- Device description
- Device labeling
- Instructions for use
- ISO 13485 Certification
- Detailed Manufacturer Information
- Design verification and validation documents
- Risk management document
- DoC (Declaration of Conformity)
- LoA (Letter of Authorization)
The registration application must be written in Indonesian, and submission documents vary by product class.
Please refer to the link below for details.
Selamat Datang di Situs Resmi Kementerian Kesehatan Republik Indonesia
Biomedical and Genome Science Initiative (BGSI) BGSi merupakan program inisiatif nasional pertama oleh Kementerian Kesehatan RI dalam rangka mengembangkan precision medicine bagi masyarakat.
www.kemkes.go.id
If you have any questions about medical device in Indonesia,
Please contact us with the below.
info@jnmglobal.net