When it comes to SaMD, IVD, and Medical Software registration in Israel, precision and expertise are essential in navigating the regulatory landscape.
Securing the right local Israeli Registration Holder (IRH) is paramount.
The Israeli Ministry of Health (IMOH) and its AMAR division, oversee the digital health services registration process, ensuring the safety, integrity, and quality of these healthcare solutions.
In this guide, we’ll explore the significance of Israeli Registration Holder services and their responsibilities.
Israeli Ministry of Health SaMD, IVD, and Medical Software Regulations
Through its Medical Devices Division (AMAR), the IMOH establishes and enforces regulations aligned with the European Union’s Medical Device Regulations (MDR).
While inspired by the MDR, specific Israel-centric requirements exist.
Staying informed about these nuances is vital for successful SaMD, IVD, and Medical Software submissions.
The Role of the Israeli Registration Holder in E-Health Services
The Israeli Registration Holder (IRH) acts as the local representative for companies outside Israel in the SaMD, IVD, and Medical Software sectors.
The local Israeli Registration Holder plays a critical role in compliance and regulatory affairs
Approval and Connectivity
IRHs must be approved and connected to the “AMAR SAFE” software, facilitating communication with the IMOH.
Global Adverse Event Reporting
Reporting adverse events and non-conformities of these SaMD, IVD, and Medical Software worldwide is crucial for monitoring and compliance.
Valid ISO 9001 Certificate
Maintaining this certificate demonstrates a commitment to quality management capabilities and implementation.
Monitoring and Reporting
IRHs monitor, collect, and report adverse events and non-conformities specific to the SaMD, IVD, and Medical Software to the IMOH.
Collaboration with IMOH
In cases of non-conformities, complaints, or recalls, IRHs work with the IMOH to address and resolve these matters.
Communication of Changes
Keeping the IMOH updated about any changes, minor and major ones, impacting SaMD, IVD, and Medical Software reliability, safety, or quality is essential.
The SaMD, IVD, and Medical Software Registration Process in Israel
To provide a comprehensive understanding, let’s outline the general steps involved in the registration process:
Determine the appropriate risk class for the SaMD, IVD, and Medical Software
Prepare a comprehensive Technical File for the SaMD, IVD, and Medical Software
Quality Management System
Implement and maintain a QMS complying with international standards and good practices
Evaluate conformity of the SaMD, IVD, and Medical Software with applicable requirements.
Information Confidentiality and security
Ensure the SaMD, IVD, and Medical Software are designed and function in a way that protects personal health information and secures other information defined as critical.
Apply the SaMD, IVD, and Medical Software for registration to the IMOH with all required documentation and forms.
Review and Approval
The IMOH reviews the application and ensures compliance with regulatory requirements. In case additional clarifications or documents are needed, they should be delivered.
Monitor SaMD, IVD, and Medical Software performance and comply with surveillance requirements.
Renew the registration license, typically every 5 years.
Choosing a Reliable Israeli Registration Holder for your SaMD, IVD, and Medical Software
While an IRH is a mandatory regulatory requirement, hiring one from a neutral, reliable, and well-experienced Israeli consulting firm offers several advantages. Such firms if are well experienced with SaMD, IVD, and Medical Software regulations, provide long-term reliability and efficient collaboration with IMOH personnel, mitigating potential business risks from conflicts of interest with local entities like distribution companies.
Navigating the Israeli registration process for SaMD, IVD, and Medical Software requires expertise and adherence to regulations.
A reputable IRH ensures compliance, efficient communication, and peace of mind as these solutions enter the Israeli market.