Other, for dental uses

X-ray apparatus for dental uses

CDSCO CLEARANCE · CPCB CLEARANCE · +1 OTHER PGAS

HSN 9022 13 00 (Other, for dental uses) 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), which governs import of medical devices including dental X-ray apparatus. Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies as an additional overlay for radiotherapy equipment and accessories.

What this is

HSN code

9022 13 00

Chapter

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

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
EPR authorisation from CPCB
Batch release certificate from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

CPCBCPCB·Central Pollution Control Board

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for the dental X-ray apparatus as a medical device listed under G.S.R. 102(E) dated 11-02-2020. Upload the certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) in e-Sanchit before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · CDSCO medical device registration conditions
2
Verify whether an Extended Producer Responsibility authorisation from the Central Pollution Control Board is required under Schedule I of the E-Waste (Management) Rules, 2022. The EPR obligation does not apply to micro-enterprises as defined under the MSME Development Act, 2006; all other importers must hold a current EPR authorisation before clearance.
E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022

A word of counsel

The most common error on this tariff line is overlooking the CPCB Extended Producer Responsibility requirement: importers who hold a valid CDSCO registration but fail to obtain EPR authorisation face consignment detention at the port of entry. The EPR authorisation is a pre-import obligation — it cannot be regularised after out-of-charge — and applies to all importers except micro-enterprises formally certified under the MSME Development Act, 2006.

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Frequently asked

Does HSN 9022 13 00 require BIS certification?

No, dental X-ray apparatus falls outside the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under G.S.R. 102(E) dated 11-02-2020, with a concurrent CPCB Extended Producer Responsibility obligation under the E-Waste (Management) Rules, 2022.

Which e-Sanchit document codes are mandatory at the bill of entry for this HSN?

Three documents must be uploaded in e-Sanchit before customs out-of-charge: certificate of analysis (0010dc), batch release certificate (0030dc), and label of consignment (0110dc), all as specified in the CDSCO compliance conditions.

Is the EPR authorisation from CPCB required for all importers of dental X-ray apparatus?

No. The EPR obligation under Schedule I of the E-Waste (Management) Rules, 2022 is waived for micro-enterprises as defined in the MSME Development Act, 2006; all other importers must hold a current CPCB EPR authorisation prior to import.

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