CDSCO Registration for Surgical Gloves & PPE Kits: Updated Rules for 2025

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.

⭐ What Are Surgical Gloves & PPE Kits Classified As Under CDSCO?

Under the updated classification rules:

1. Surgical Gloves

• Classified as Class B Medical Devices

(Moderate risk — requires detailed quality documentation)

2. PPE Kits / Coveralls

• Classified as Class A or Class B, depending on the model, material, and intended use.
• High-protection PPE Kits fall under Class B requiring compulsory CDSCO Registration.

Because these products are widely used in medical, diagnostic, and emergency settings, CDSCO ensures that only tested, safe, and compliant products enter the market.

⭐ Is CDSCO Registration Mandatory in 2025?

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.

⭐ Why Is CDSCO Registration Important?

• Ensures product safety and quality
• Prevents fake/low-grade products in the medical market
• Helps brands build trust with hospitals and government buyers
• Required for participating in tenders (government + private)
• Mandatory for import clearance at ports

Without CDSCO Registration, products may face:
❌ penalties
❌ seizures
❌ cancellation of licenses
❌ supply disruptions

⭐ CDSCO Registration Requirements for Surgical Gloves & PPE Kits (2025 Updated List)

You must prepare the following documents to apply:

✔ 1. Device Master File (DMF)

Contains technical details such as:

• Product specifications
• Material composition
• Sterility validation report
• Biocompatibility testing reports
• Packaging validation

✔ 2. Plant Master File (PMF)

Includes:

• Factory layout
• Quality management system details
• SOPs
• Production process

✔ 3. ISO 13485 Certificate

Mandatory for all medical device manufacturers.

✔ 4. Test Reports

From NABL-accredited labs, including:

• Tensile strength
• Sterility testing
• Water leak test
• Viral penetration test (for PPE kits)

✔ 5. Labels & Packaging Details

✔ 6. Free Sale Certificate (FSC) (Importers only)

✔ 7. Undertaking & Declarations

⭐ CDSCO Registration Process for Surgical Gloves & PPE Kits (Step-by-Step)

Step 1 — Determine Device Classification

Surgical gloves = Class B
PPE kits = Class A/B

Step 2 — Gather Required Documents

Prepare DMF, PMF, test reports, ISO certificates, etc.

Step 3 — Create Account on CDSCO SUGAM Portal

Step 4 — Submit Application

Apply under MDR 2017 for registration of Class A/B devices.

Step 5 — Query Resolution

CDSCO may ask questions or request additional information.

Step 6 — Receive Approval

Once approved, CDSCO issues your Registration Certificate.

Step 7 — Begin Manufacturing/Import

After registration, you can legally sell surgical gloves & PPE kits across India.

⭐ CDSCO Registration Fees (2025 Guide)

Domestic Manufacturers

• Class B device registration fee: approx. ₹5,000 – ₹20,000

Importers

• Class B import license: approx. $1,000 – $3,000 (varies by product)

(Fees may change based on CDSCO updates.)

⭐ Common Reasons for CDSCO Registration Delays

• Incomplete testing reports
• Incorrect device classification
• Missing ISO 13485 certificate
• Poor-quality technical documents
• Not responding to CDSCO queries on time

Prepare documents properly to avoid rejection.

⭐ Conclusion: Why You Must Complete CDSCO Registration in 2025

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:

• Smooth business operations
• Hospital partnerships
• Import-export approvals
• Participation in medical tenders

…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 solves legal and compliance issues of new and established businesses.