Rubber contraceptives, female (diaphragms), such as cervical caps

Rubber contraceptives, female diaphragms and cervical caps

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 4014 10 20 (Rubber contraceptives, female diaphragms) 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) vide G.S.R. 102(E) dated 11-02-2020. Import is conditional on compliance with all registration and licensing conditions specified in that notification before out-of-charge at the port of entry.

What this is

HSN code

4014 10 20

Chapter

40 · Rubber and articles thereof

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Certificate of analysis from manufacturer
Batch release certificate from manufacturer

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 female diaphragm or cervical cap as a medical device listed under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must be current and all conditions specified in the notification must be fulfilled prior to import.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
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 the bill of entry is assessed. The proper officer must verify all three documents are uploaded before granting out-of-charge.
CDSCO PGA facilitation protocol · e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The single most common error on this tariff line is confusing CDSCO device registration with the document-upload obligation: an importer holding a valid CDSCO registration but failing to upload all three mandatory e-Sanchit documents — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc) — will face detention and demurrage even though the underlying regulatory approval is in order. Each shipment requires fresh document uploads; a prior bill-of-entry upload does not carry forward to subsequent consignments.

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Frequently asked

Does HSN 4014 10 20 require BIS certification?

No, female rubber contraceptives such as diaphragms and cervical caps are not within any BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare vide G.S.R. 102(E) dated 11-02-2020.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Three documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc). All three must be present in e-Sanchit before the customs proper officer grants out-of-charge.

Does the CDSCO registration requirement apply to all quantities or is there an exemption for sample imports?

The regulatory record does not record a sample-import exemption; G.S.R. 102(E) dated 11-02-2020 applies the registration condition without a quantity carve-out, so CDSCO registration and full e-Sanchit documentation are required for every consignment.

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