Indonesia: Medical Devices Economy & Regulatory Update
Indonesia Encourages Investment
Economic growth shows an increasing trend, and this includes the Pharma and Medical Device Industry
New strategic infrastructure such as highway, airport, dam, powerplant, railway, etc.
Economic deregulation to simplify and accelerate public service
Increase in skilled workforce
Local Manufacture Development
Minister of Health Regulation No. 62 / 2017 regarding Marketing Authorization of Medical Devices, IVD Medical Device, & Household Health Product
Indonesia already implement the Digital signature system on January 2019 for the marketing license approval, CFS/COE and declaration letter.
Marketing license approval and other license is signed in the form of electronic format.
Doesn't need stamp and direct signature
Marketing license may be printed by Applicant and other designated bodies through official website.
Collaborate with State Cyber and Cryptography Agency.
QR Code used for safety and verify-able by Android and IOS application (for purpose of inspection and law enforcement).
SIKLARA is a Risk Classification Tool that help applicants to identify the risk class of medical device and IVD in line with AMDD Risk Classification Rules.
Good Clinical Practice of Medical Device
Reference: Indonesia Ministry of Health
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