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
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
|
Labeling 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.
