Parts and accessories
Parts and accessories for lasers and optical instruments
HSN 9013 90 00 (Parts and accessories) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the parts or accessories fall within the medical devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must ensure the device registration and all MOHFW-notified conditions are satisfied before filing the bill of entry.
- Registration certificate from CDSCO
- Import licence from CDSCO
- 1Determine whether the parts or accessories being imported are listed in G.S.R. 102(E) dated 11-02-2020 issued by MOHFW. Where listed, obtain the applicable CDSCO registration for the medical device and ensure all conditions notified therein are met before the bill of entry is filed.G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
- 2Upload the CDSCO registration certificate and any other mandatory documents required under G.S.R. 102(E) in e-Sanchit at the bill of entry stage. Consignments not accompanied by a current CDSCO registration are liable to detention pending regularisation.G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
The most common error on this tariff line is importing parts and accessories under HSN 9013 90 00 without first confirming whether the specific component is captured within the G.S.R. 102(E) schedule of regulated medical devices. Not all optical instrument parts are regulated medical devices — but those that are require a standalone CDSCO registration; a registration held for the parent finished device does not automatically cover separately imported parts or accessories.