Indian Medtech Finds Errors In New Draft List Classifying Devices, IVDs

India’s industry association claims that some of the products on the regulator’s new draft list classifying over 700 medical devices and IVDs have been categorized incorrectly. The list is expected to be finalized at least three months before new medical device rules come into effect in January 2018.

Taj Mahal
The medtech industry has found discrepancies in India's device classification list • Source: Shutterstock

Indian medical device industry association AiMeD says it has identified errors in the Central Drugs Standard Control Organization’s recent draft list that classifies over 700 medical devices and in vitro diagnostics.

During its initial review of the list, the trade association noticed that some of the devices had been classified incorrectly,...

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 Regulation

Under Pressure: How To Safeguard The EU Responsible Person

 

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.

Number of Persons Responsible For Regulatory Compliance Grows Nearly 10%

 

The EU’s Medical Device and IVD Regulations require every manufacturer and authorized representative to have a PRRC. As compliance becomes mandatory for increasing numbers of manufacturers, figures are soaring and this role is becoming both increasingly distinctive and more complex.

Italy’s Responsible Person Sanctions Approach Raises Eyebrows

 

Fines are a fact of life when it comes to manufacturers’ compliance with EU rules on persons responsible for regulatory compliance. But Italy’s stance adds pressure on individuals appointed to the role.

A Trillion On The Table. Addressing Disparities In Women’s Health Isn’t Just Right. It’s Smart.

 

Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.

More from Policy & Regulation

Smaller Companies Next Frontier for FDA’s Voluntary Improvement Program

 
• By 

At the Medical Device Innovation Consortium summit, Cogmedix's Scott Cook discussed the challenges and benefits of transitioning to the FDA's Voluntary Improvement Program, which promotes honesty and opportunities for improvement, leading to faster market access and cost savings.

Italy’s Responsible Person Sanctions Approach Raises Eyebrows

 

Fines are a fact of life when it comes to manufacturers’ compliance with EU rules on persons responsible for regulatory compliance. But Italy’s stance adds pressure on individuals appointed to the role.

A Trillion On The Table. Addressing Disparities In Women’s Health Isn’t Just Right. It’s Smart.

 

Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.