Indonesia
- Regulatory Authority:
Ministry of Health (MoH)
- Legislation:
ASEAN Medical Devices Directive
- Authorized Representative:
yes, country resident appointed through official Letter of Authorization (LoA)
- Registration period:
1 to 2 months
Medical Devices/IVDs Class A
3 to 4 months
Medical Devices/IVDs Class B/C
4 to 6 months
Medical Devices/IVDs Class D
- Language of labeling and documentation:
Indonesian, English
- Certificate validity period:
max 5 years (depending on the validity of authorization letter issued by the foreign manufacturer)
- Notes:
On-site audit not required
Local Tests required for some kind of medical devices
Local Clinical Evaluation not required
A brief algorithm for registration of medical devices in Indonesia:
Document preparation:
Technical documentation of the product
Documents confirming safety and effectiveness
Certificates of compliance with international standards
Examination and evaluation:
An authorised body examines the submitted documents and may request additional data or samples for testing.
Registration and receipt of certificate:
After successful examination, a registration certificate is issued, which allows the medical device to be legally sold and used in Indonesia.