On February 11 , 2020, In order to ensure all medical devices is of the same standard & quality, the Union Health Ministry has issued a notification declaring all medical devices used on humans or animals as the category of “drugs”.
This notification, effective from April 1, 2020, was made in accordance with sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.
Key Points:
i.New rule:So now all imported & indigenously built medical devices sold in India need to ensure clear specific safety and to be verified by the Central Drugs Standard Control Organisation (CDSCO)before they are introduced in the India market. With this, companies making medical devices have to be accountable for the safety and quality of their products.
ii.Equipments: Medical devices include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator & devices used in diagnosis, monitoring or treatment namely Syringes, Catheters, Glucometer, Digital thermometer included in the category.
iii.Benefits:This move will help Government to check quality standards for all devices including imported ones & also can control price by placing them on the essential drugs list.
iv.Present scenario:At present, only 23 categories of medical devices can be controlled under the law & 37 more categories of devices will be regulated after the new rule.
v.Registration:According to the Medical Device Amendment Rules 2020 notified by the Ministry, medical devices will have to be registered with the Central Licensing Authority and this work can be done online from the website set up by CDSCO.
vi.Time-limit:The notification also stipulates a time limit for registering the devices. Accordingly, low or medium risk devices (category A and B) must register within 30 months and medium to high and high risk devices (category C and D) within 40 months.
vii.Background :In April 2019, India’s highest advisory body on technical issues related to drugs and medical devices, the Drugs Technical Advisory Board (DTAB) had recommended that all medical devices should be notified as drugs under the Drugs and Cosmetics Act,1940.
About Ministry of Health and Family Welfare:
Formed– 1976
Headquarters– New Delhi
Union Minister– Harsh Vardhan
