**Summary:**
Government of India, Directorate General of Health Services, Central Drugs Standard Control Organisation, Medical Devices and Diagnostics Division issued Notice No. 29Misc032020DC 124, dated 2m2 (likely March 22nd), regarding the requirement of fees for changes in the address of an authorized agent, without any change in the constitution, as a post-approval change under the Medical Devices Rules (MDR), 2017. Based on received representations, the notice clarifies that fees are not required for post-approval changes involving a change in the authorized agent's address (without a change in constitution) because Schedule VI of MDR, 2017, does not prescribe such fees. The decision was made following an examination of the representations received. The notice was issued under the authority of Dr. V.G. Somani. The issuing office is located at FDA Bhawan, Kotla Road, New Delhi – 110002.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India responsible for health services.
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
Medical Devices and Diagnostics Division: A division within the Central Drugs Standard Control Organisation focused on medical devices and diagnostics.
FDA Bhawan, Kotla Road, New Delhi: Location of Central Drugs Standard Control Organisation office in Delhi.
MDR, 2017: Medical Devices Rules, 2017. A set of regulations governing medical devices in India.
Schedule VI of MDR, 2017: Refers to the schedule of fees within the Medical Devices Rules, 2017.
Authorized Agent: Refers to the authorized representative of a medical device manufacturer.
Dr. V.G. Somani: A person involved in the policy, possibly an official within the regulatory framework.
No. 29/Misc/03/2020-DC (124)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Medical Devices and Diagnostics Division)
FDA Bhawan, Kotla Road,
New Delhi-110002.
Dated: 2//¢)/>m2
Notice
Subject: Requirement of fees for change in address of authorized agent,
without change in constitution as Post Approval Change under MDR,2017-reg.
In light of representations received, requesting this office for the removal of the
requirement of fees if there is a change in the address of Authorized Agent without
change in constitution.
Having examined the representation, it is observed that there is no
requirement of fees prescribed in Schedule-VI of MDR, 2017 for post approval
changes in case of change in address of authorized agent without change in
’
? mur. . ca lesirr iow oF abou. the fees may not be required for change of address of
ithorized agent without change in constitution under MDR, 2017.
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(Dr. V.G. Somani)