Medical Devices Regulatory Services in Indonesia
Your Partner for End-to-End Regulatory Affairs Services in Indonesia, From Strategy to Registration and Post Approval Maintenance
Artixio offers extensive regulatory services to global manufacturers, facilitating smooth navigation of Indonesia’s MDA regulations.
Medical devices sold in Indonesia are regulated by the National Agency of Drug and Food Control (NADFC) which is responsible for the import, manufacture, export and supply of medical devices in Indonesia to safeguard public health and safety.
Services
Regulatory Intelligence & Strategy
MDR Gap Assessment
Medical Device Regulatory Affairs
Quality Consulting
Technical and Medical Writing
Clinical, Performance Evaluation
Medical Device Registration / Certification
Authorized Agent / Legal Representation
Post Market Surveillance
Key Regulations for Medical Devices in Indonesia
Regulation of the minister of health on product license for medical devices, in vitro diagnostic medical devices and household health products.
Regulation of the Minister of Health Number 1190/MENKES/PER/VIII/2010 on Product License of Medical Devices and Household Health Products
Regulation of the Minister of Health Number 1189/MENKES/PER/VIII/2010 on Medical Device Production and Household Health Products
Regulation of the Minister of Health Number 1191/MENKES/PER/VIII/2010 on Medical Devices Distribution.
Classification of Medical devices
In Indonesia, devices are classified to Class A, B, C and D depending on their risk level. Class A devices have low risk to patients, Class B devices are low to moderate risk, Class C devices are moderate to high risk while Class D devices are high risk, complex devices.
Process for Registration of Medical Devices in Indonesia
Documents Required for Registration of Medical Devices in Indonesia
The documents required for medical device Indonesia are in accordance with CSDT, below are the elements
- Executive Summary
- Device Description
- Design Verification & Validation
- Clinical Evidence
- Device Labelling
- Risk Analysis
- Manufacturer Information
Artixio’s Medical Devices Registration Services in Indonesia
Our Regulatory and Market Access experts based in Indonesia, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in Indonesia. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality regulatory affairs services to support your business needs.
Why Artixio?
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
120+ Countries supported
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Product Experience: Devices, Diagnostics, Combination Drugs, Software as Medical Devices (SaMD), Consumer Devices
Diverse Experience across Complex Therapeutic areas and Application Areas
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
KPI based, continual process excellence
Represent your organization and device in Indonesia
FAQs
What is the validity of the medical device license in Indonesia?
The Validity of the Medical Device license is maximum 5 years.
Who can Import Medical Devices?
The Company which has PAK license and Product License for the imported Medical Devices.
When should the Product License holder apply for a renewal of Product license?
The Product License holder can apply for the renewal of the license not prior to 9 months from the date of expiry.
How to Submit the New application for the Product License of Medical Devices?
The New application is submitted online through Indonesian National Single Window portal or website address regalkes.kemkes.go.id.
What is a Production Certificate and who is Producer?
Production Certificate is a certificate to produce medical devices; Producer is any company formed as business entity that owns Production Certificate to produce including to assemble and/or repackage the Medical Devices domestically.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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