FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

Australia – TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices

Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate...
Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

USA – Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal...

A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding...
India Proposes Making Marketers Responsible for Drug Product Quality

India – India to Treat Implants and Imaging Equipment as Drugs From April 2020

India is pushing ahead with previously discussed plans to categorize certain classes of medical device as drugs. The change will mean implants and imaging...
TGA Creates Guidance on Device Standards for Quality Management Systems

Australia – Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

Australia’s Therapeutic Goods Administration (TGA) opened a consultation on Monday to obtain feedback on its proposal to reclassify all spinal implantable medical devices to...
MHRA launches consultation on how to best engage patients and the public

UK – Medical devices: information for users and patients

What is a medical device? A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. It...
CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

USA – Exemptions for Unclassified Devices: CDRH Updates Guidance

The US Food and Drug Administration (FDA) on Friday updated a guidance from 2015 describing its intent to exempt certain unclassified medical devices from...
TGA Proposes 5 Medical Device Classifications in Line With EU MDR

USA – Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds

The US Food and Drug Administration (FDA) sent a letter to health care providers on Wednesday to raise awareness on additional cases of breast...
7 Pro Tips for New and Aspiring Roboticists

USA – 7 Pro Tips for New and Aspiring Roboticists

It's been nearly two decades since Intuitive Surgical launched its first da Vinci system and yet, in many ways, the field of robotic-assisted surgery is...
Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices

India – Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical...

India has become the latest medical device market whereby regulators have begun accepting electronic indications for use (eIFU) for registrations. Manufacturers can realize...
WHO Advances International Harmonized Nomenclature for Medical Devices

International – WHO Advances International Harmonized Nomenclature for Medical Devices

The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International...

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