Sheets and plates of polarising material

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9001 20 00 (Sheets and plates of polarising material) is subject to Central Drugs Standard Control Organisation (CDSCO) registration requirements under the Medical Devices Rules, 2017, where the product falls within the medical device categories listed in G.S.R. 102(E) dated 11 February 2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must ensure compliance with all registration conditions stipulated in that notification before filing the bill of entry.

What this is

HSN code

9001 20 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
Determine whether the specific polarising sheet or plate being imported falls within the medical device categories listed in G.S.R. 102(E) dated 11 February 2020 issued by MOHFW. If it does, obtain the requisite CDSCO registration and comply with all conditions specified in that notification before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Verify whether the product also qualifies as a telecom product under the Mandatory Testing and Certification of Telecom Equipment (MTCTE) scheme. If notified under MTCTE, ensure compliance with the Indian Telegraph (Amendment) Rules, 2017 and DoT/TEC notifications, including F.No. 5-2/2024-TC/TEC (Pt.1) dated 25-02-2025.
Indian Telegraph (Amendment) Rules, 2017 · DoT Notification TEC/01/2017-TC dated 04-07-2019 · F.No. 5-2/2021-TC/TEC/131 dated 13-06-2022 · F.No. 5-2/2024-TC/TEC (Pt.1) dated 25-02-2025

A word of counsel

The most common error on this tariff line is assuming that all polarising sheets and plates fall under the CDSCO medical-device regime when only those specifically enumerated in G.S.R. 102(E) do; industrial or display-grade polarising material used outside a medical application does not attract CDSCO registration. Equally, where a polarising component is integrated into a telecom product notified under MTCTE, the CDSCO and DoT/TEC compliance tracks operate independently — clearing one does not satisfy the other, and an absent MTCTE certificate is grounds for detention even when CDSCO registration is in order.

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Frequently asked

Does HSN 9001 20 00 require BIS certification?

No. No BIS Quality Control Order covers sheets and plates of polarising material under this tariff line. The applicable regulatory framework is CDSCO registration under the Medical Devices Rules, 2017 where the product is listed in G.S.R. 102(E) dated 11 February 2020 issued by the Ministry of Health and Family Welfare.

How do I determine whether my polarising sheet requires CDSCO registration?

Check whether the product is enumerated in G.S.R. 102(E) dated 11-02-2020 issued by MOHFW; only products listed therein are subject to CDSCO registration conditions. Products outside that list and outside any notified MTCTE category may be imported without a PGA clearance at the bill of entry.

Can a polarising sheet or plate attract both CDSCO and MTCTE requirements simultaneously?

Yes. If the product meets the definition of a listed medical device under G.S.R. 102(E) and is also notified under the MTCTE scheme per the DoT/TEC notifications, both regulatory tracks apply independently and must each be satisfied before out-of-charge is granted.

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