Artificial teeth

Artificial teeth for dental prosthetic use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 21 00 (Artificial teeth) 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 and related conditions prescribed in that notification before a bill of entry is filed.

What this is

HSN code

9021 21 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 artificial teeth as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration must be current and must cover the specific device category being imported; import without a valid CDSCO registration constitutes a contravention of the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
Ensure all conditions stipulated in G.S.R. 102(E) dated 11-02-2020 — including registration, labelling, and any importer-of-record obligations — are met before filing the bill of entry. Non-compliance with any prescribed condition renders the consignment liable to detention and refusal of out-of-charge.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is assuming that a general CDSCO importer licence is sufficient without separately verifying that the specific artificial-teeth device model and its manufacturer are covered by the CDSCO registration on file. G.S.R. 102(E) imposes device-level and manufacturer-level conditions; a registration that covers one product configuration does not automatically extend to a variant or a secondary foreign supplier, and a mismatch at the bill-of-entry stage results in consignment detention.

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Frequently asked

Does HSN 9021 21 00 require BIS certification?

No, artificial teeth 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.

Does the CDSCO registration cover all artificial teeth variants from the same foreign manufacturer?

Registration under G.S.R. 102(E) is subject to conditions prescribed therein; importers should confirm that the specific device model and the foreign manufacturing facility are both within the scope of the registration before filing the bill of entry.

What happens if artificial teeth are imported without a valid CDSCO registration?

Import without CDSCO registration violates the Medical Devices Rules, 2017, exposing the consignment to detention, refusal of out-of-charge, and potential confiscation, with the importer subject to monetary penalty and prosecution under the Drugs and Cosmetics Act, 1940.

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