Of plastics

Plastic frames and mountings for spectacles or goggles

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9003 11 00 (frames and mountings of plastics for spectacles, goggles or the like) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is conditional on compliance with all registration requirements specified in that notification.

What this is

HSN code

9003 11 00

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 the plastic spectacle or goggle frames as a medical device listed under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must cover the specific device category and must be current and valid at the time of import.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification · Medical Devices Rules, 2017
2
Upload the CDSCO registration certificate and all supporting compliance documents in e-Sanchit prior to bill-of-entry filing. Non-upload of mandatory PGA documents triggers detention at the port pending customs out-of-charge verification.
G.S.R. 102(E) dated 11-02-2020 · CDSCO registration conditions

A word of counsel

The most common error on this tariff line is assuming that plastic spectacle frames, classified under an optical-instruments chapter, fall outside the medical-device registration net. G.S.R. 102(E) dated 11-02-2020 brings these frames within the scheduled medical-device list, and CDSCO registration is a pre-import mandatory — not a post-clearance formality. Consignments arriving without a valid CDSCO registration are liable to detention and refusal of out-of-charge, regardless of the apparent non-clinical nature of the product.

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Frequently asked

Does HSN 9003 11 00 require BIS certification?

No, plastic spectacle and goggle frames 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, pursuant to G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Is CDSCO registration required for all plastic frames under this HSN, or only for corrective-lens frames?

G.S.R. 102(E) dated 11-02-2020 lists the device categories subject to CDSCO registration; importers should verify whether their specific frame sub-type falls within the scheduled categories, as the obligation attaches to the listed device description rather than end-use.

What happens if an importer files a bill of entry without a valid CDSCO registration for these frames?

Customs will refuse out-of-charge, and the consignment is liable to detention at the port; prolonged detention attracts demurrage and ground rent, and the consignment may ultimately face re-export or confiscation under the Medical Devices Rules, 2017.

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