CDSCO certification for medical devices

Baid hails mandatory CDSCO certification for all medical devices

April, 2019

Mr Himanshu Baid, Chairman, CII Medical Technology Division & Managing Director, Polymedicure Ltd

 BS RAWAT
NEW DELHI : Mr Himanshu Baid, Chairman, CII Medical Technology Division & Managing Director, Polymedicure Ltd., hailed the government's decision making it mandatory for all medical devices to get Central Drugs Standard Control Organisation (CDSCO) certification.

Mr Baid told DTMT, “This is a very positive step aimed to prevent incidents similar to the Johnson & Johnson faulty implant case.”

He explained, “Now, all medical devices that meet the definition, irrespective of whether they have been notified or not, will be covered and therefore, will have to meet certain standards of quality and value."

He noted, “Earlier to this, we have made many representations to the government for regulating all non-notified medical devices including diagnostic kits manufactured or imported in the country.”

Giving an example he said, “Analysers, instruments etc. are some of the medical devices used in various hospitals and health institutions for diagnosis, treatment, mitigation  which are currently out of range of regulation under the Drugs and Cosmetics Act."

However, he told DTMT that they were very disappointed about a notification that said all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators — will be treated as drugs for human treatment with effect from April 1, 2020.

He claimed that CDSCO’s high-tech online application system, ‘Sugam’ is a major achievement as far as both the industry and the regulator’s office are concerned.

According to the notification all imported, as well as local medical devices sold across India will soon be required to clear safety and quality standards.