Indonesia Medical Device Registration

Indonesia Medical Device Registration: A Comprehensive Guide

Regulatory Authority

Ministry of Health (MoH)

The Indonesian Ministry of Health (MoH) plays a pivotal role in overseeing the registration process for medical devices and household health supplies within the country. 

A notable aspect of this regulatory framework is that products approved by the U.S. Food and Drug Administration (FDA) and available in the U.S. often find a streamlined authorization process for entry into the Indonesian market. This reflects a harmonization of standards, facilitating the import of FDA-approved products.

Driving the regulatory efforts is the Directorate General of Pharmaceuticals and Medical Devices, a dedicated program with a multi-faceted mission. One key objective is to enhance the accessibility of essential medicines and healthcare products, ensuring a robust supply chain. Concurrently, the program seeks to foster self-sufficiency in the production of pharmaceuticals and medical devices, promoting domestic capabilities. 

Moreover, a crucial aspect of its mandate involves meticulous quality control measures to uphold the standards of medical devices. By accomplishing these objectives, the Directorate General contributes significantly to the broader transformation of the health sector in Indonesia, emphasizing efficiency, accessibility, and quality in healthcare delivery.

Link for Regulatory Authority

https://www.kemkes.go.id/id/home

Local Regulation

ASEAN Medical Devices Directive

Classification of Medical Devices 

Class A, B, C and D

Listing or Registration Requirements

Part 1: Pre-Market Control

• Manufacturer License (ISO 13485 for QMS)
• Distribution License (Good Distribution Practice)
• Registration License (ASEAN CDST)

Part 2: Post -Market Control

• Sampling
• Monitoring
• Vigilance
• Advertisement

Documents Required for Indonesia Medical Device Registrations

• Executive Summary
• Device Labelling
• Detailed Manufacturer Information
• Essential Principles of Safety and Performance of Medical Device and Method Used to demonstrate conformity
• Summary of Design verification and validation documents
• Risk Analysis
• Method of destruction
• Quality Management Certification
• Letter of Certification of the intended use/indication/ Package, Letter of certification of label and instruction for use from manufacturer or product owners
• Declaration of Conformity
• Letter of Confirmation for market history proof from manufacturer
• Letter of Safety confirmation from manufacturer
• Proof of approval from Medical Device Regulatory Authority in Foreign Countries
• Letter of Authorization
• Grouping indication letter (if needed)

Registration Timeline

• Class A: 30 days
• Class B: 60 days
• Class C: 75 days
• Class D: 90 days 

Registration Fee

• Class A: IDR 1,500,000 (approximately USD 102)
• Class B: IDR 2,000,000 (approximately USD 136)
• Class C: IDR 3,000,000 (approximately USD 204)
• Class D: IDR 4,000,000 (approximately USD 272)

License Validity

The Registration import medical device license has a validity of minimum 2 years and maximum 5 years. Spare parts and accessories do not require registration.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

Efficiency Review

The registration process for medical devices in Indonesia necessitates the submission of essential administrative documents. These include device labeling, a detailed device description encompassing features, intended use, indications, instructions for use, contraindications, warnings, precautions, potential adverse effects, and other pertinent specifications. Certain devices may also mandate the submission of documentation related to pre-clinical studies and risk analysis assessments. 

Quality system conformity assessment

To facilitate Indonesia’s medical device registration, ISO 13485 certificates are mandatory. These certificates serve as official confirmation of the quality systems implemented at both the legal and actual manufacturing facilities.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk