What is medical device/accessory registration?

2020-08-06T17:38:05+00:00December 27th, 2018|

A medical device/accessory may be marketed only after having been approved as a medical device and registered in the Medical Devices Department of the Ministry of Health in accordance with the conditions of registration.

The purpose of medical device registration is to ensure the safety and effectiveness of medical devices and their accessories that are used in the health systems in the State of Israel. Medical device/accessory certification is for finished products only.

Product Development, Delivery System & Clinical Trials

Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials

Growing, Manufacturing & Lab Facilities Design

Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices

Quality Assurance & Good Practices (GxP)

An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training

Cultivation & Product Manufacturing Technology

Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.

New Product Regulations & Submissions

Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets

Qualification &Validation

New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports

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