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MoHFW issues Draft Medical Devices (Amendment) Rules 2022

The Ministry of Health and Family Welfare (MoHFW) has issued Draft Medical Devices (Amendment) Rules, 2022 to further amend Medical Devices Rules, 2017.

In rule 87 which specify “Provision for sale of medical devices” the following amendments has been made: –

• Sub rule (1)(A) has been inserted:
“Notwithstanding anything contained in sub-rule (1), any person intends to sale medical devices exclusively as referred in clause (zb) of rule 3 shall obtain registration certificate as provided hereinafter in these rules”

• Rule 87(A) has been inserted:
“Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device”

• Rule 87(B) has been inserted:
“Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device”

• Rule 87 (C) has been inserted:
“Validity of registration certificate”

• Rule 87 (D) has been inserted:
“Suspension and cancellation of Registration Certificate”

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at [email protected] before 45 days from February 9, 2022.

“Thankfully this is reasonable and minimal requirements to register by a reseller of medical devices and on lines with our recommendations to CDSCO & MOH&FW. It’s a good intent to register and for the regulators to know the vast landscape before attempting to regulate it as Medical Device are sold in malls by non chemists eg spectacles, wheel chairs, personal weighing machines, adult diapers, and oxymeters- these are all medical devices under Medical Devices regulations – though our request is still outstanding to have a separate medical devices law that will decriminalise most minor offences as medical devices are not drugs,” said Rajiv Nath, Forum Coordinator, AiMeD

Please click: Draft Medical Devices (Amendment) Rules, 2022
MB Bureau

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