On January 13, 2018 the Indonesia Ministry of Health implemented Permenkes No. 62, 2017, Marketing Authorization of Medical Devices, IVD Devices and Household Goods. This is the first major overhaul of medical device regulations in seven year (replacing Permenkes No. 1190, 2010) with the intent to improve efficiency, harmonize with ASEAN MDD standards, and align with updates to Indonesian legal and import regulations.
Important provisions include:
- device definitions harmonized with ASEAN MDD
- device classification harmonized with ASEAN MDD
- technical data formatting harmonized with ASEAN MDD (CDST)
- application review times for medical device registration cut in half (15 days for Class A, 30 days for Class B and C and 45 days for Class D) for import goods
- implementation of E-reporting systems for distribution records and complaint handling through E-Watch systems
- clear requirements for post market vigilance
Implementation of the new Rules has been rather smooth with new faster review timelines largely being met. Indonesia is the third country to implement the ASEAN MDD standards after Singapore and Malaysia, with the Philippines announcing plans for implementation in early 2019.