31/03/2026
๐ข ๐๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ง๐ญ ๐๐ฉ๐๐๐ญ๐: ๐๐๐ฐ ๐๐๐๐๐ ๐๐๐๐๐ง๐๐ฎ๐ฆ ๐๐จ๐ซ ๐๐๐ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐ข๐จ๐ง๐ฌ ๐ข
The Central Drugs Standard Control Organization (CDSCO) has released Addendum No. 02 to the FAQs on In-Vitro Diagnostic (IVD) Medical Device Regulations
If you are a manufacturer, importer, or regulatory professional in the IVD space, here is what you need to know about the latest updates to the Medical Devices Rules, 2017:
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License Retention: Endorsements and base licenses must now be retained simultaneously.
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Site Relocation: Any change in the location of a domestic manufacturing site now requires a mandatory QMS re-inspection for a fresh license.
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Product Applications: To avoid delays, CDSCO advises limiting applications to 15 products per submission.
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Software Updates: Version changes or updates to approved software must be submitted via a Post-Approval Change (PAC) application.
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Veterinary IVDs: Clinical Performance Evaluation (CPE) is officially not required for new Veterinary IVDs.
โ ๏ธ Deadline Alert: Donโt ignore portal alerts! Applications will be deemed withdrawn if no response is submitted after the 4th automated reminder.
Addendum Release Date: March 13, 2026.
Reference Doc No: CDSCO/IVD/FAQ/04/2022.
Stay compliant and keep your registrations up to date! ๐ก๏ธ
More information at :
In-Vitro Diagnostic (IVD) Medical Devices Division, Frequently Asked Questions โ released by CDSCO โ Addendum No.:02, dated 13.03.2026 Update: CDSCO Releases New Addendum on IVD Medicalโฆ