Blog Category: Medical Device

Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

December 15, 2021
Medical Device

Japan(PMDA) MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387 At the This Pharmaceuticals and Medical Devices Safety Information (PMDSI) publication is issued reflective...

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Reclassification of Spinal Implantable Medical Devices

December 3, 2021
Medical Device

This guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. All spinal implantable medical devices are...

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Categorization and Registration Process for Devices in EUDAMED

November 19, 2021
Medical Device

Categorization of Devices Categorization of devices to be registered in EUDAMED include: Regulation Devices – Regulation Devices are defined as medical devices and in vitro diagnostic...

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Guidance on Premarket Submission for Device Software Functions

November 12, 2021
Medical Device

The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software...

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Medical Devices – USA/Europe Regulatory Updates round up – Oct 2021

November 5, 2021
Medical Device

EUROPE1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

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Medical Devices – Asia Regulatory Updates Roundup – Oct 2021

November 3, 2021
Medical Device

Philippines(FDA) 1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the PhilippinesThis Circular aims to: Specify the establishments classified as retailers...

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