Operon Strategist

India Waives Local Trials: Exemption for Investigational Medical Devices with EU Clearance

In a major regulatory update for India’s MedTech sector, the Union Ministry of Health and Family Welfare has officially notified amendments to the Medical Devices Rules (MDR), 2017. The final notification expa...

SFDA Medical Device Establishment License (MDEL): Complete Compliance Guide

Under Article 6 of the Law of Medical Devices (Royal Decree No. M/54), any entity engaging in medical device activities within Saudi Arabia must be registered and licensed by the Saudi Food and Drug Authority (SFDA). The Medical...

Panel Recommends Decentralisation of Medical Device Licensing to SLAs Overview - Decentralisation of Medical Device Licensing

The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended decentralising the licensing of Class A and B medical devi...

Medical Device Technical Documentation for MDR: CE Marking Compliance Guide

Compiling Medical Device Technical Documentation for MDR is a mandatory prerequisite for placing any medical device on the European Union market. Under the European Union Medical Device Regulation (EU MDR 2017/745), technica...

Vital Signs Devices Guidance: Manufacturing & Regulatory Compliance

Vital signs devices are indispensable medical instruments that provide continuous or spot-check measurements of a patient’s primary physiological parameters. These vital parameter monitors measure heart rate, non-invasive blood pressur...