India Proposes Regulating Implants And Imaging Equipment As Drugs

Proposals to classify high-end medical devices as drugs are out for comment in India.

in CT laboratory. Observation room in an office with a computer tomograph
CT scanners are among the devices India wants to regulate as drugs

India is proposing to subject all implantable medical devices, CT scanners and other high-end medical equipment to existing regulatory and registration rules governing drugs.

Aside from implantable products and CT scanners, X-ray machines, MRI equipment, PET scanners, dialysis systems, defibrillators and bone marrow cell...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Asia

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

 

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 

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

 

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

 

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

 

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

 

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

 

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