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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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Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products – FDA Draft Guidance

December 11, 2021
Diagnostics

Use of Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products FDA issued the draft guidance as part of its Real World Evidence (RWE) Program...

Drug and Biological Products, FDA Draft Guidance, Real-World Data, Real-World Evidence

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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Control of Nitrosamine Impurities in Human Drugs

November 26, 2021
Food

FDA is implementing Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing Practice (CGMP) guidance for the control of nitrosamine impurities in human drugs without prior public...

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The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and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