Overview

Indonesia, the world's largest island country, has initiated universal health care for their citizens in 2014. This has greatly influenced the growth of medical devices market and lead to the rise in their import. Medical Devices in Indonesia are regulated by National Agency of Drug and Food Control (NADFC) functioning under Indonesian Ministry of Health (MOH). The latest regulation in place for import of Medical Devices is Decree No. 62 imposed in the year 2017.  

The current regulation, classifies the devices as A, B, C and D based on risk, and requires the manufacturers to appoint a local representative with a Distributor License. But, the country has a history for being dynamic in changing regulations periodically.

Freyr’s team of experts keep a track of changing trends and regulations, and help the stakeholders in maintaining Regulatory compliance throughout the product life cycle. We offer Regulatory solutions to maintain other Regulatory aspects of compliance within the constrained budgets.

 

Indonesia Market Entry for Medical Devices - Process Flow

Indonesia Medical Device Regulations

 

 

Freyr Expertise

  • Regulatory Guidance for Registration
  • Medical Device Classification
  • Indonesian Local Representation
  • Document Compilation and Application
  • Post-Market Surveillance

 

Summary

S. No

Regulatory Parameter

Indonesia

1

Regulatory Authority

National Agency of Drug and Food Control
(NA DFC)

2

Regulation

No. 62 / 2017

3

Risk Classification

Class A

Class B

Class C

Class D

4

Regulatory Pathway

Marketing License Application

5

Authorized Representative

Indonesian Agent Required

6

Fee payable

Class A

$105*

Class B

$210*

Class C

$210*

Class D

$350*

7

QMS Requirement

ISO 13485

8

Assessment of Technical Data

NA DFC

9

Validity of License

5 Years

10

Labelling Requirements

No. 62 / 2017

11

Submission format

Online/Paper

12

Final Outcome

Marketing License with Number

13

Timelines

6 - 9 Months

14

Language

English & Indonesian

*The price is as per records at the time of documentation and is subject to change.