Medical Device Market Size
- Market Value: In 2024, Indonesia’s medical device market reached USD 2.3 billion, with imports contributing USD 1.5 billion and local production USD 1.4 billion.
- Growth Projections: The market is anticipated to grow, with revenues projected to reach USD 2.37 billion by 2025 and USD 3.19 billion by 2029.
- Future Growth Potential
- Government Initiatives: The Indonesian government is actively promoting local manufacturing, aiming to reduce reliance on imports.
- Healthcare Infrastructure: Expansion of healthcare facilities and increased investment in the sector are driving demand for medical devices.
Registration Process
- Pre-Market Approval: Medical devices must obtain approval from the Ministry of Health (MoH) before entering the market.
- Classification: Devices are classified into four categories (A, B, C, D) based on risk, with Class A being low risk and Class D high risk.
- Submission Requirements: Manufacturers must submit technical documentation, including safety and efficacy data, labeling, and instructions for use.
- Local Representation: Foreign manufacturers are required to appoint a local authorized representative to liaise with the MoH.
- Post-Market Surveillance: Ongoing monitoring of device performance and reporting of adverse events are mandatory.
- Other Information
- Regulatory Authority: The Directorate General of Pharmaceutical and Medical Devices under the MoH oversees medical device regulation.
- Import Regulations: Importers must obtain an import license and ensure compliance with local standards.
- Language Requirements: All documentation and labeling must be in Bahasa Indonesia.