CDSCO CDSCOCDSCO/IVD/FAQ/04/2022 — Addendum 02
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
CDSCO/IVD/FAQ/04/2022 — Addendum 02 is the official CDSCO identifier for “Addendum 02 to FAQs on IVD Medical Devices — 13 March 2026”. CDSCO/IVD/FAQ/04/2022 — Addendum 02 is the official identifier CDSCO uses for this instrument.
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- CDSCO
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- CDSCO/IVD/FAQ/04/2022 — Addendum 02
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- English
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- Published
- March 13, 2026
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Addendum 02 to FAQs on IVD Medical Devices — 13 March 2026
Complete official seven-page IVD FAQ Addendum 02 dated 13 March 2026. Preserves all 24 questions, including Question 7 on the same-manufacturer Subsequent Importer route and related PAC/retention distinctions. This is an issued FAQ addendum with its public-awareness notice, distinct from the 2026 draft IVD-import guidance. It does not reproduce the complete dedicated portal checklist.
CDSCO/IVD/FAQ/04/2022 — Addendum 02 is the official identifier CDSCO uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.