Naramedic
Naramedic is a specialized licensing service for medical devices, household health supplies (PKRT), and IVDs in Indonesia. Established in 2020, we have been trusted by over 100 companies and 50 medical device brands.
Certification, Licensing,and Registration forMedical Devices & PKRT
Certification, Licensing,
and Registration for
Medical Devices & PKRT
We assist clients in planning and managing the entire process of certification, licensing, and registration for Medical Devices (Alkes) & Household Health Supplies (PKRT) in accordance with Ministry of Health regulations accurately, effectively, and efficiently. Our support enables clients to grow into competitive, high-quality companies that innovate and improve healthcare services in Indonesia.
We assist clients in planning and managing the entire process of certification, licensing, and registration for Medical Devices (Alkes) & Household Health Supplies (PKRT) in accordance with Ministry of Health regulations accurately, effectively, and efficiently. Our support enables clients to grow into competitive, high-quality companies that innovate and improve healthcare services in Indonesia.
Registration for Medical Device and In-Vitro Diagnostic (IVD) Distribution License
Extension/Modification of Medical Device & In-Vitro Diagnostic (IVD) Distribution License
Notification Medical Devices
Medical Device Distribution License (IDAK)
Registration for Household Health Supplies (PKRT) Distribution License
Extension/Modification of Household Health Supplies (PKRT) Distribution License
Quality Certification for Medical Devices & PKRT
Quality Certification
for Medical Devices & PKRT
We assist clients with the complete licensing process for CDAKB, CPAKB, and CPPKRTB in accordance with Ministry of Health regulations—ensuring accuracy, efficiency, and compliance to support business growth and competitiveness in the health sector.
We assist clients with the complete licensing process for CDAKB, CPAKB, and CPPKRTB in accordance with Ministry of Health regulations—ensuring accuracy, efficiency, and compliance to support business growth and competitiveness in the health sector.
Quality Management System
Quality Management
System
We assist clients in the implementation and complete certification process for the Quality Management System (ISO) in accordance with Ministry of Health regulations—ensuring accuracy, efficiency, and compliance to support business growth and competitiveness in the health sector.
We assist clients in the implementation and complete certification process for the Quality Management System (ISO) in accordance with Ministry of Health regulations—ensuring accuracy, efficiency, and compliance to support business growth and competitiveness in the health sector.
Other Services
Other Services
INAPROC / E-Catalogue v6
We assist in registering your products into the INAPROC / E-Catalogue v6 system, the official government procurement platform. This service opens up broad access to the government market, ensuring transparent and efficient transaction processes in compliance with Indonesian regulations.
E-Report
The E-Report service is a reporting system for medical device manufacturers and distributors. It facilitates efficient reporting of production and distribution data, ensuring transparency, accurate data management, and compliance with all applicable industry regulations.
E-Suka
The E-Suka/Suket service assists medical device manufacturers and importers in obtaining essential certificates for legal compliance. We manage the entire administrative process, ensuring your products meet all safety, quality, and marketing standards.
Holding License
Naramedic provides Holding License Services to support companies entering the ASEAN market. We act as your trusted local license holder, ensuring compliance, business continuity, and regulatory readiness without requiring local entity establishment.
Advanced Consultation
Advanced Consultation offers in-depth sessions for medical device stakeholders to master licensing requirements. Our experts discuss the latest regulations, potential challenges, and strategic approaches to ensure legal compliance and smooth market entry.
