The demand for surgical gloves and PPE kits in India continues to grow due to rising healthcare awareness, hospital safety standards, and mandatory compliance requirements. As these products directly impact patient and user safety, the Central Drugs Standard Control Organisation (CDSCO) has strict regulations for their manufacturing, import, and sale.
If you are planning to manufacture or import these products, obtaining CDSCO Registration is now a mandatory requirement under the Medical Device Rules (MDR) 2017.
In this blog, we break down all the updated CDSCO rules for 2025, classification, documentation, fees, and the exact procedure manufacturers must follow.
Under the updated classification rules:
(Moderate risk — requires detailed quality documentation)
Because these products are widely used in medical, diagnostic, and emergency settings, CDSCO ensures that only tested, safe, and compliant products enter the market.
Yes.
From 2023 onwards, CDSCO added surgical gloves and PPE kits to the mandatory registration list, and the enforcement has become stricter in 2024–2025.
Meaning:
If you manufacture, import, distribute, package, or store these products, you must have valid CDSCO Registration.
Without CDSCO Registration, products may face:
❌ penalties
❌ seizures
❌ cancellation of licenses
❌ supply disruptions
You must prepare the following documents to apply:
Contains technical details such as:
Includes:
Mandatory for all medical device manufacturers.
From NABL-accredited labs, including:
Surgical gloves = Class B
PPE kits = Class A/B
Prepare DMF, PMF, test reports, ISO certificates, etc.
Apply under MDR 2017 for registration of Class A/B devices.
CDSCO may ask questions or request additional information.
Once approved, CDSCO issues your Registration Certificate.
After registration, you can legally sell surgical gloves & PPE kits across India.
Domestic Manufacturers
Importers
(Fees may change based on CDSCO updates.)
Prepare documents properly to avoid rejection.
For businesses involved in surgical gloves or PPE kits, CDSCO Registration is no longer optional—it is an essential compliance requirement. With stricter enforcement, only certified and tested products are allowed in the market.
If you want to ensure:
…then completing CDSCO Registration on time is crucial.
To learn more about CDSCO Registration in Haryana, Gujarat, Maharashtra and Uttar Pradesh we recommend you to visit Metacorp as it solve legal and compliance issues of new and established businesses.
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