Prismatic eyeglasses for reading

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9004 90 20 (Prismatic eyeglasses for reading) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare (MOHFW) via G.S.R. 102(E) dated 11-02-2020. Import is conditional on compliance with all registration and licensing conditions specified in that notification.

What this is

HSN code

9004 90 20

Chapter

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

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
MOHFW notification compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for prismatic eyeglasses for reading as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration must be current and in the name of the Indian importer or their Authorised Indian Representative before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Ensure all conditions of import specified in G.S.R. 102(E) dated 11-02-2020 are met at the bill of entry stage, including any licensing requirements issued by CDSCO. Non-compliance renders the consignment liable to detention and re-export or confiscation under the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is filing the bill of entry without a valid CDSCO registration in place, on the assumption that reading-aid eyeglasses are optical accessories rather than regulated medical devices. G.S.R. 102(E) dated 11-02-2020 expressly lists this product family, and a consignment arriving without a current registration is detained at port — demurrage and ground rent accrue until either the registration is produced or the consignment is re-exported.

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 9004 90 20 require BIS certification?

No, prismatic eyeglasses for reading are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Is a separate CDSCO import licence required in addition to the device registration?

G.S.R. 102(E) dated 11-02-2020 requires compliance with all conditions specified therein, which include both registration and any applicable licensing obligations under the Medical Devices Rules, 2017; confirm the specific conditions applicable to your device class with CDSCO before filing.

Does an Authorised Indian Representative satisfy the CDSCO registration requirement for a foreign manufacturer?

Yes. Under the Medical Devices Rules, 2017, a foreign manufacturer may appoint an Authorised Indian Representative to hold the CDSCO registration, provided that representative accepts full regulatory responsibility for the imported device in India.

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