Any firm, distributor, or business looking to engage in wholesale distribution or stock and sale of medical devices in India.
Any firm, distributor, or business looking to engage in wholesale distribution or stock and sale of medical devices in India.
The MD 42 License is valid for 5 years from the date of issue unless cancelled or suspended.
Yes, the State Licensing Authority verifies the premises before granting the license.
Yes, it can be renewed within 6 months prior to expiry.
MD 41 is the application form, while MD 42 is the actual certificate/license issued after approval.
The MD 42 License is required for the wholesale distribution of notified Class A, B, C, and D medical devices as listed under the Medical Device Rules, 2017.
Yes, a company can hold both, provided it meets the facility and compliance requirements for each license separately as defined by the State Licensing Authority.
On average, the approval process takes 30 to 60 days, depending on documentation completeness, inspection schedules, and the State Licensing Authority’s workflow.
Yes, applicants must employ a competent technical person with the required educational qualifications and experience as specified in the Medical Device Rules.
No, the MD 42 License is non-transferable. A new application must be filed if ownership, constitution, or address of the firm changes.
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