Other
Optical radiation instruments for physical or chemical analysis (UV, visible, IR)
HSN 9027 50 90 covers other instruments and apparatus using optical radiations (UV, visible, IR), and import is subject to Central Drugs Standard Control Organisation (CDSCO) registration where the device is listed under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies concurrently for analysers and accessories. Import of used or refurbished high-end medical equipment is additionally restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import permit from MOHFW
- 1Confirm whether the specific instrument is a medical device listed under G.S.R. 102(E) dated 11-02-2020. If listed, obtain CDSCO registration before filing the bill of entry; import without valid CDSCO registration is non-compliant with the conditions specified in that notification.G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board covering analysers and accessories under Schedule I of the E-Waste (Management) Rules, 2022. The EPR obligation does not apply to micro-enterprises as defined under the MSME Development Act, 2006.E-Waste (Management) Rules, 2022 · G.S.R. 801(E) dated 02-11-2022
- 3If importing used or refurbished high-end, high-value medical equipment, comply with the conditions and restrictions issued by MEFCC vide Office Memorandum dated 15-12-2023; this category is Restricted and cannot be cleared without satisfying the conditions specified therein. Critical care medical equipment is carved out from this restriction.MEFCC Office Memorandum dated 15-12-2023
The most common error on this tariff line is treating all optical analytical instruments as outside the medical-device regime. Whether CDSCO registration is required turns entirely on whether the specific instrument appears in the notified device list under G.S.R. 102(E) dated 11-02-2020; instruments used in clinical diagnostics routinely fall within that list while general laboratory analysers may not. Filing a bill of entry without first resolving the CDSCO scope question exposes the consignment to detention pending PGA verification.