To all importers / Local agents/Market authorization holders of medical Devices.
Exemption of Performance Evaluation (Clinical Evaluation) For Medical Devices (MDs) and In Vitro Devices (IVDs)
1. National Medicine Regulatory Authority (NMRA) has decided to use regulatory reliance principle and exempt the performance evaluation (Clinical evaluation/Sample Evaluation) for following general medical devices (Non IVD Medical Devices) and In-vitro diagnostics medical devices. The decision has been taken to expedite the registration process.
- - In-vitro diagnostics medical devices. (New applications) approved by World Health Organization (WHO) or WHO reference regulatory authorities (Food and Drug Administration -USA, Therapeutic Goods Authority-Australia, Health Canada, Health Sciences Authority – Singapore and Ministry of Health, Labour and Welfare – Japan). One year provisional registration will be granted.
- - Covid -19 essential medical devices (New application of Non IVD Medical Devices) approved by one of NMRA reference country (USA, Australia, Canada, UK, Netherland, Japan, Denmark, Germany, Switzerland, Norway, Sweden, France, Italy). One year conditional provisional registration will be granted with pending performance evaluation.
- - Already registered / marketed General Medical devices (Non- medical IVDs) and in-vitro diagnostic medical devices (IVDs) which don’t have complaints/quality issues.(Renewal applications)
2. Application (File/Dossier) shall submit with all necessary documents including original commercial packs/ labels.
3.Samples with commercial packs need to be submitted as a registration sample when required by NMRA.(Except for medical equipment)