ON September 30, the Ministry of Health and Family Welfare published the Medical Devices (Fifth Amendment) Rules, 2022, through which it notified a new rule, 87A which deals with registration certificates to sell, stock, exhibit or offer for sale or distribute a medical device, including in vitro diagnostic medical devices. With the amendment coming into effect, all store owners selling thermometers, condoms, face masks, spectacles, or any other medical device will now have to get registered with the state licensing authority.
In exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the central government, after consultation with the Drugs Technical Advisory Board, further amended the Medical Devices Rules, 2017. Under the new rules:
• The state licensing authority shall appoint licensing authorities for the purpose of issuing registration certificates under this part for such areas as may be specified.
Any person who intends to sell, stock, exhibit or offer for sale or distributes a medical device, including in vitro diagnostic medical device, shall make an application in Form MD-41 to the state licensing authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution. The application needs to contain details of the applicant or firm, including its constitution, along with identification proof, such as, Aaadhar card or PAN card, along with documentary evidence in respect of ownership or occupancy on rental of the premises. It also requires details of competent technical staff, under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:
• holds a degree from a recognized university/institution; or
• is a registered pharmacist; or
This story is from the {{IssueName}} edition of {{MagazineName}}.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber ? Sign In
This story is from the {{IssueName}} edition of {{MagazineName}}.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber? Sign In
PIL, Difficult To Swallow?
In a recent ruling, the Bombay High Court lamented the increasing number of frivolous public interest litigations being filed in courts and echoed the sentiments of the Supreme Court that such litigations are the bane of the judicial system. Is there any way to restrict their misuse?
Till Infertility Do Us Part...
The Calcutta High Court slammed a husband for initiating divorce proceedings due to his wife's infertility and asked him to be a pillar of support for her. Courts have often taken an empathetic view in such matters
IS THAT LEGAL?
Ignorance of law is no excuse. Here are answers to frequently asked queries regarding matters that affect us on a day-to-day basis
The Big Lie
In America, The Big Lie is an idiom used by Donald Trump's opponents and the media to describe his constant gripe about election fraud. Now, it seems more suited to another Republican, Congressman George Santos (right), who has been facing growing calls to resign after he admitted fabricating parts of his resume and biography since his election in New York last year.
Flying into the Sunset
Over 50 years since the first and original jumbo jet, the Boeing 747, took to the skies and revolutionized air travel, the last of the legendary aircraft (right) was delivered to a freight charter company, bringing down the curtain on one of aviation's most successful products.
Star Crossed
Actor and producer Alec Baldwin is a Hollywood legend, having starred in a range of movies, award winning TV sitcoms, and theatre. He was most recently seen in Mission Impossible Fallout, which is an apt description of his current situation.
Walkouts in the UK
An estimated half a million workers have gone on strike, shutting down thousands of schools, public transport and border disruption. It is the biggest day of industrial action for more than a decade.
Myanmar's Misery
Two years after the military coup ousted the elected government led by Aung San Suu Kyi, the brutal crackdown by the junta on so-called \"insurgents\" and civilian protesters has reached a new level with the use of air strikes, a new and deadly tactic in the ongoing civil war.
AMERICA'S ANGST
From messy, divisive politics to a series of mass shootings, and now black officers brutally beating another black man to death as seen in bodycam videos, America's domestic convulsions are cause for serious introspection
JUSTICE LEAGUE
There are few judicial appointment procedures in the world that are completely bereft of the overarching presence of either the executive or the legislature, or both. In the end, the judge is left with all the powers vested in him/her by the constitution to uphold the rule of law, within an atmosphere of external influences
