DCGI Clarifies On Applicable Environmental Conditions For Equipment Regulated From Next Year

Mumbai, 18 Nov 2019:

The Drugs Controller General of India (DCGI) has clarified that the environmental conditions as per Medical Devices (MD) Rules, 2017 will be applicable for the equipment which are to be regulated from next year.

Various stakeholders had sought a clarification regarding the environmental conditions for the equipment which are to be regulated from January 1 and April 1, 2020.

In this regard, DCGI in a notice clarified that the environmental conditions referred in fifth schedule, annexure 'A' of Medical Devices Rules, 2017 such as well ventilated area with neat and clean environment, free from dust and other particulate matter, air conditioning will be applicable for equipment regulated from next year.

Central Drugs Standard Control Organization (CDSCO) has mandated that medical devices like all implantable medical devices, CT scanning equipment, X-ray equipment, MRI equipment, dialysis machines, bone marrow cell separators, defibrillators and PET equipment will require registration and import licensing under the MD Rules, 2017.

Both new Indian market entrants as well as companies currently selling such devices in the country will have to register with CDSCO by the April 2020 deadline in order to continue legally marketing these products.

Most recently, CDSCO identified four other device types including nebulizers and digital thermometers that will fall under the MD Regulations, 2017 starting in January 2020. Pharmabiz