INNOVATIVE MEDICAL DEVICE REVIEW (IMDR) APPLICATION

 

INTRODUCTION

An innovative medical device is commonly defined as a device that introduces a novel idea in technology use or performance. It incorporates new technology or a significant improvement in design, effectiveness, or efficacy compared to existing medical devices, demonstrating meaningful clinical benefits and addressing identified unmet clinical needs.

To facilitate the growth of innovative medical devices, the Medical Device Authority has established a step-by-step application process for Innovative Medical Device Review (IMDR) for both industry and academia. As this initiative takes place prior to the placement of a medical device on the market, it is designed to assist relevant parties in understanding expectations for compliance within the regulatory requirements landscape.

Interested parties may refer to the following step-by-step application process and the following reference documents. Application for Innovative Medical Device Review can be made through the application form

Reference Documents

  1. Innovative Medical Device Review Application Form (Word/ PDF)
  2. Step-By-Step Process For Innovative Medical Device Review (IMDR) Application
  3. Appendix 1: Definition Of A Medical Device As Outlined Under Section 2 Of Act 737
  4. Appendix 2: Innovative Medical Device Designation Criteria
  5. Appendix 3: Technology Readiness Level Chart