MOHFW proposes amendments to Medical Device Rule/s; Loan Licence to Manufacture for Sale/Distribution of Class C/D Medical Devices will be given by the Central Licensing Authority

MOHFW proposes amendments to Medical Device Rule/s; Loan Licence to Manufacture for Sale/Distribution of Class C/D Medical Devices will be given by the Central Licensing Authority

March 13, 2019 OPS, Pharmaceuticals, states 0

Ministry of Health and Family Welfare (“Ministry”) has proposed to amend Form MD-10, in Appendix of the Medical Devices Rules, 2017 (“Rules”) and released the draft Medical Devices (……Amendment) Rules, 2019.

The application for obtaining Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device is to be made to the Central Licensing Authority (“CLA”) in Form MD – 8 through the online portal of the Ministry.  If the CLA is satisfied that the requirements of the Rules have been complied with, then the CLA will grant a licence in Form MD-10 or may reject the application for reasons to be recorded in writing.

The proposed amendment is relating to substituting “State Licensing Authority” with “Central Licensing Authority” as the undersigned authority in Form MD-10.

Comments/Suggestion are invited till 5th April, 2019 to be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.

SourceMinistry of Health and Family Welfare

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