Endoscopes

Endoscopes and other medical instruments, appliances

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9018 90 44 (Endoscopes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import of used or refurbished endoscopes carries additional restrictions under the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023, with a defined list of equipment permitted in refurbished condition per CBIC Instruction 08/2024-Customs and Instruction 25/2024-Customs.

What this is

HSN code

9018 90 44

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · Medical Devices Rules, 2017 read with G.S.R. 102(E) dated 11-02-2020

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Refurbishment compliance from MEFCC

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Obtain CDSCO registration for the endoscope as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration — covering both the device and the foreign manufacturer — must be valid and uploaded in e-Sanchit before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
If importing used or refurbished endoscopes, confirm the specific model and equipment category appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. Import of high-end, high-value used medical equipment not on that list is Restricted and subject to MEFCC conditions per the Office Memorandum dated 15-12-2023.
CBIC Instruction 08/2024-Customs dated 05-04-2024; CBIC Instruction 25/2024-Customs dated 28-10-2024; MEFCC O.M. dated 15-12-2023

A word of counsel

The most common error on this tariff line is assuming that a valid CDSCO device registration is sufficient for used or refurbished consignments. The MEFCC refurbishment restriction operates independently of the CDSCO regime: an endoscope may be fully registered with CDSCO yet still be detained at the port of import if the equipment category does not appear on the CBIC Instruction 08/2024-Customs or 25/2024-Customs permitted list. Verify the permitted-equipment list against the precise model and specification before the purchase order is placed.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 9018 90 44 require BIS certification?

No, endoscopes are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017 read with G.S.R. 102(E) dated 11-02-2020, with an additional MEFCC overlay for used and refurbished equipment.

Which endoscopes are permitted for import in a used or refurbished condition?

Only equipment categories expressly listed in the annexures to CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024 may be imported in old or refurbished state; all other high-end, high-value used medical equipment remains Restricted under the MEFCC O.M. dated 15-12-2023.

Does the CDSCO registration requirement apply to both new and refurbished endoscopes?

Yes. CDSCO registration under G.S.R. 102(E) dated 11-02-2020 is mandatory for all imports of listed medical devices regardless of condition; refurbished consignments must additionally satisfy the MEFCC refurbishment conditions before out-of-charge is granted.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / MOHFW / MEFCC / Indian Customs CUSDATA.