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Australia Proposes New Guidance On Regulating Boundary & Combination Products

 
• By Ian Schofield

The Australian regulator wants to hear stakeholders’ views on proposals to help decide whether a product is a medicine, a medical device or a biological – or none of the above.

Stethoscope with Australia flag background. - Image
Australia wants clearer distinctions between different therapeutic products • Source: Shutterstock

Medtech and pharma companies operating in Australia have just over three weeks to comment on draft Australian guidance on how to choose the most appropriate regulatory pathway for products that do not clearly fit within the existing definitions for medicines, biologicals or medical devices.

The new guidance, which has been drafted by the Therapeutic Goods Administration, is intended to replace the existing guideline...

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More from Asia

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 
• By Brian Bossetta

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

South Korean Health Ministry Sees Benefits Of Pre-Regulatory Review

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

More from Geography

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 
• By Brian Bossetta

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

Commission Decision Launches Pediatric And Rare Disease Expert Group

 
• By Amanda Maxwell

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.