Indonesia: Medical Devices Economy & Regulatory Update

August 28, 2019

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

 

 

Guidance Development 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Minister of Health Regulation No. 62 / 2017 regarding Marketing Authorization of Medical Devices, IVD Medical Device, & Household Health Product

 

Digital Signature

  • 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

 

 

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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