This episode delves into the critical factors for introducing medical devices to the Indonesian market. We cover the regulatory framework, including the role of the Ministry of Health and the necessity of a Local Authorized Representative. We also discuss device classification, licensing, extensive documentation requirements like ISO 13485 and CSDT, labeling in Bahasa Indonesia/English, the new Halal certification mandate from January 2023, import restrictions, taxes, post-market surveillance, and license validity. Practical advice is offered to help manufacturers navigate this complex landscape.

Key Questions:

• What is the role of Indonesia's NADFC/BPOM in medical device registration?

• Why is a Local Authorized Representative essential for foreign manufacturers in Indonesia?

• How does device classification (Class A-D) impact your market entry strategy?

• What are the key documents needed for the CSDT dossier, including ISO 13485?

• What are the language and labeling requirements for medical devices in Indonesia?

• Is Halal certification now mandatory for medical devices in Indonesia, and since when?

• What import restrictions and taxes should manufacturers anticipate?

• What are the post-market surveillance obligations in Indonesia?

• How long are medical device licenses valid in Indonesia and what's the renewal process?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.