- Surgical masks are Class A medical devices under CDSCO's risk classification — the lowest-risk category, alongside bandages and examination gloves.
- Importers apply on Form MD-14 and receive the import license on Form MD-15, through an Indian Authorized Agent.
- Wholesalers and distributors apply on Form MD-41 and receive the registration certificate on Form MD-42 to legally stock and sell surgical masks.
- Manufacturers of Class A surgical masks apply on Form MD-3 and receive the manufacturing license on Form MD-5 from the State Licensing Authority.
Introduction
CDSCO registration for surgical mask in India follows three role-based pathways, since surgical masks are classified as Class A (low-risk) devices under the Medical Devices Rules, 2017. Manufacturers apply on Form MD-3 and are granted a manufacturing license on Form MD-5 by the State Licensing Authority. Importers apply on Form MD-14 through an Indian Authorized Agent and receive the import license on Form MD-15 from the Central Licensing Authority.
Wholesalers and distributors apply on Form MD-41 and receive the registration certificate on Form MD-42 from the State Licensing Authority. If the mask is non-sterile and non-measuring, manufacturers can use the simplified Chapter IIIB self-registration route instead of the full MD-3/MD-5 license. All applications are filed online through CDSCO's SUGAM portal.
What Is CDSCO Registration for Surgical Mask?
CDSCO registration for surgical mask is the regulatory approval that the Central Drugs Standard Control Organisation (CDSCO) requires before any surgical mask can be legally manufactured, imported, sold, or distributed in India. It is issued under the Medical Devices Rules, 2017 (MDR 2017), framed under the Drugs and Cosmetics Act, 1940. Because surgical masks are notified medical devices, every business in the supply chain — manufacturer, importer, or wholesaler — has a distinct filing obligation, even though the product itself sits in the lowest risk category.
The exact pathway you need depends on your role: making the mask, bringing it into India from abroad, or stocking and selling it in the domestic market. Each role has its own application form, its own licensing authority, and its own fee structure, which is exactly what this guide breaks down below.
CDSCO Classification of Surgical Masks: Why They Fall Under Class A
Under the Medical Devices Rules, 2017, CDSCO groups all medical devices into four risk-based classes — A, B, C, and D — following the Global Harmonization Task Force model, where Class A is low risk and Class D is high risk. Surgical masks are non-invasive, do not enter the body, and only contact intact skin, which places them squarely in Class A alongside bandages, examination gloves, and tongue depressors.
Within Class A, CDSCO further distinguishes 'non-sterile, non-measuring' devices, which get the lightest-touch route. Most standard 2-ply and 3-ply surgical masks fall in this bucket, which means:
- They are exempt from the full licensing provisions under Chapters IV, V, VII, VIII, and XI of MDR 2017.
- They still require mandatory online registration under Chapter IIIB, filed through the SUGAM portal, in place of a full manufacturing license.
- A manufacturer that wants the formal license route anyway — for example, to support institutional or export requirements — can still apply through Form MD-3 and be granted Form MD-5.
| Aspect | Class A Surgical Mask Position |
| Risk category | Class A (low risk) — non-invasive, external-use device |
| Manufacturer route (non-sterile, non-measuring) | Self-registration under Chapter IIIB via SUGAM |
| Manufacturer route (formal license) | Form MD-3 application → Form MD-5 manufacturing license, State Licensing Authority |
| Import route | Form MD-14 application → Form MD-15 import license, Central Licensing Authority |
| Wholesale/distribution route | Form MD-41 application → Form MD-42 registration certificate, State Licensing Authority |
Because CDSCO's risk-classification list is dynamic and updated periodically, it's worth double-checking your specific mask against the current official list on the CDSCO website or SUGAM portal before you file.
Who Needs CDSCO Registration for Surgical Mask? (Importer vs Manufacturer vs Wholesaler)
CDSCO registration for surgical mask is not a single, one-size-fits-all filing — it is role-specific. The table below summarises which form applies to which business.
| Role | Application Form | Grant Form | Licensing Authority |
| Manufacturer (Class A surgical mask) | MD-3 (or Chapter IIIB registration for non-sterile/non-measuring) | MD-5 | State Licensing Authority |
| Importer (any class) | MD-14 | MD-15 | Central Licensing Authority (CDSCO HQ) |
| Wholesaler / Distributor / Stockist | MD-41 | MD-42 | State Licensing Authority |
CDSCO Manufacturing License for Surgical Masks (Class A) — Form MD-3 & MD-5
Any business manufacturing surgical masks in India for sale or distribution falls under the manufacturing provisions of MDR 2017. Since surgical masks are Class A devices, the application is filed in Form MD-3 with the State Licensing Authority, and once approved, the manufacturing license is granted in Form MD-5.
Eligibility for MD-3/MD-5
- The manufacturing unit must have adequate infrastructure, equipment, and a documented Quality Management System appropriate to a Class A device.
- A qualified, competent technical person must oversee production and quality control at the manufacturing site.
- The device must conform to Bureau of Indian Standards (BIS) requirements where notified, or to validated manufacturer/ISO standards where no BIS standard exists.
Documents Required for MD-3
- Duly filled Form MD-3 application with the prescribed fee
- Company constitution documents, factory premises proof, and layout plan
- Device Master File describing the mask's design, materials, and intended use
- Plant Master File / Site Master File covering the manufacturing process
- Details of technical staff and their qualifications
- Quality Management System documentation (ISO 13485 certification, where held)
- Labels, packaging artwork, and Instructions for Use (IFU)
- Fee payment challan generated on the SUGAM portal
Process & Timeline for MD-3/MD-5
The application is filed online through the SUGAM portal to the State Licensing Authority. For Class A devices, the review is comparatively light-touch, and the authority may or may not carry out a physical site visit depending on the specific product and state practice. Once the documentation is found satisfactory, the manufacturing license is granted in Form MD-5. Manufacturers of non-sterile, non-measuring surgical masks who prefer the lighter Chapter IIIB registration route instead of a full MD-3/MD-5 license can self-register the device on SUGAM, which is typically the faster of the two options.
CDSCO Registration for Surgical Mask Importers — Form MD-14 & MD-15
Any business bringing surgical masks into India for sale or distribution needs an import license from CDSCO. The application is filed in Form MD-14 and, once approved, the license is granted in Form MD-15.
Who Applies
A foreign manufacturer cannot apply directly. The application must be filed by an Indian Authorized Agent, appointed through a notarised and apostilled Power of Attorney. This agent must already hold a valid wholesale license (Form MD-42) or a manufacturing license (Form MD-5) before it can file Form MD-14 on the SUGAM portal.
Documents Required for MD-14
- Covering letter and duly filled Form MD-14
- Power of Attorney authorising the Indian Agent, notarised and apostilled/consularised
- Free Sale Certificate or manufacturing/marketing authorisation from the country of origin
- Device Master File (DMF) and Plant Master File (PMF) as per the Fourth Schedule
- Quality Management System certificate (e.g., ISO 13485) for the manufacturing site
- Product labels, Instructions for Use (IFU), and technical write-up
- Wholesale license (MD-42) or manufacturing license copy of the Indian Authorized Agent
- Fee payment challan generated on the SUGAM portal
Process & Timeline for MD-14/MD-15
The Central Licensing Authority may inspect the overseas manufacturing site before granting the license, either directly or through a delegated inspection body, with the applicant bearing the inspection cost. Once documents (and inspection, where applicable) are cleared, CDSCO is expected to decide the application within about nine months, granting the license in Form MD-15 or rejecting it with reasons. A rejected applicant can appeal to the Central Government, which must decide the appeal within 90 days. For Class A non-sterile, non-measuring surgical masks specifically, CDSCO has also enabled a simplified, self-declaration-based route on the MD-14 form, which typically moves faster than the standard inspection-based route.
CDSCO Wholesale License for Surgical Mask Distributors — Form MD-41 & MD-42
Any entity that wants to stock, sell, exhibit, or distribute surgical masks on a wholesale basis — dealers, stockists, distributors, and e-commerce sellers of regulated medical devices — must hold a registration certificate under the Medical Devices Rules, 2017. The application is filed in Form MD-41; once approved by the State Licensing Authority, the certificate is granted in Form MD-42.
Eligibility for MD-41/MD-42
- A qualified technical person must be engaged: typically a graduate in pharmacy, science, or life sciences; or a graduate in any discipline with at least one year of relevant experience; or a diploma holder with at least two years of relevant experience.
- Adequate storage premises that meet good distribution/storage conditions for medical devices.
- A declaration to source surgical masks only from CDSCO-registered manufacturers or licensed importers.
Documents Required for MD-41
- Duly filled Form MD-41 application
- Proof of business constitution (partnership deed, incorporation certificate, GST registration, etc.)
- Premises ownership/lease documents and a site layout plan
- Details and qualification proof of the technical staff
- Self-certification of compliance with Good Distribution Practice
- Fee payment challan generated through the SUGAM portal
Process & Timeline for MD-41/MD-42
The application is submitted online to the State Licensing Authority through the SUGAM portal. The authority may conduct a physical inspection of the storage premises to check storage conditions, recordkeeping, and staff qualifications before granting the registration certificate on Form MD-42. If the application is rejected, the applicant can appeal to the state government within 45 days of the rejection order.
Documents Required
Regardless of your role, most CDSCO surgical mask filings draw from the same core document set. Keeping these ready in advance speeds up every pathway above.
- Company incorporation/constitution documents and GST/PAN details
- Device Master File (technical description, intended use, materials, and design specifications)
- Plant Master File / Site Master File describing the manufacturing or storage premises
- Free Sale Certificate (for imported masks) issued by the country of origin's regulatory authority
- Quality Management System documentation (ISO 13485, where held)
- Labels, artwork, and Instructions for Use (IFU)
- Power of Attorney (for foreign manufacturers appointing an Indian Authorized Agent)
- Existing wholesale/manufacturing license copy of the Indian Agent (for import applications)
- Fee payment challan generated on the SUGAM portal
Step-by-Step CDSCO Registration Process for Surgical Mask (SUGAM Portal)
Confirm your surgical mask's CDSCO risk class against the official classification list — almost always Class A, non-sterile/non-measuring.
- Create and verify your organisation profile on the SUGAM portal (sugamonline.cdsco.gov.in).
- Compile the Device Master File, Plant Master File, and supporting technical and quality documents.
- Select the correct form for your role: MD-3 (manufacture) or Chapter IIIB registration, MD-14 (import), or MD-41 (wholesale).
- Upload documents, complete the online application, and generate and pay the fee challan.
- Respond promptly to any deficiency queries or clarification requests raised by CDSCO or the State Licensing Authority.
- Undergo a site inspection where applicable (more common for import and wholesale applications than for straightforward Class A manufacturing).
- Receive the grant of registration/license — MD-5, MD-15, or MD-42 — and begin lawful manufacture, import, sale, or distribution.
- Maintain post-market surveillance and adverse-event reporting, and pay the retention fee before each 5-year cycle ends.
CDSCO Registration Fees for Surgical Mask — Indicative Fee Structure
Fees are prescribed under the Second Schedule of MDR 2017 and are paid online through the SUGAM portal. They vary by role and by the number of manufacturing sites, overseas sites, or locations involved. The figures below are indicative — always confirm the current fee on the CDSCO/SUGAM fee schedule before filing.
| Application | Indicative Fee |
| Manufacturing license (MD-3/MD-5) — Class A, per site | Lower than Class C/D fees; confirm current Class A fee on SUGAM |
| Import license (MD-14/MD-15) — Class A, per overseas site | Approx. USD 1,000, plus a smaller per-product fee |
| Wholesale registration certificate (MD-41/MD-42), per location | Approx. ₹3,000 |
| Wholesale inspection fee — Class A/B | Approx. ₹5,000 (if inspected within India) |
| License retention fee | Payable once every 5 years to keep any CDSCO license active |
Validity, Renewal & Retention Fee
A CDSCO registration, license, or registration certificate for surgical mask — whether MD-5, MD-15, or MD-42 — does not carry a fixed expiry date. It remains valid in perpetuity as long as the holder pays the prescribed retention fee once every 5 years from the date of issue. If the retention fee is not paid on time, the license or certificate stands suspended, and a late fee (charged at roughly 2% of the retention fee for every month of delay) applies before it can be reinstated. Any material change — a new device variant, a change in manufacturing site, or a change of the Indian Authorized Agent — requires an endorsement or fresh filing before continued sale.
Benefits of CDSCO Registration for Surgical Mask
- Legal market access — masks cannot clear Indian customs or be lawfully sold without valid CDSCO registration.
- Buyer and hospital trust — CDSCO registration numbers are commonly verified by institutional buyers, hospitals, and government tenders.
- Smoother customs clearance for imported surgical masks with a valid MD-15 in hand.
- Access to government and institutional procurement, where CDSCO registration is typically a mandatory tender condition.
- Long-term validity — once granted, the license stays active indefinitely with only a 5-year retention fee, avoiding repeated re-licensing.
Penalties for Selling Surgical Masks Without CDSCO Registration
Manufacturing, importing, or selling surgical masks without the applicable CDSCO registration or license is an offence under the Drugs and Cosmetics Act, 1940. Consequences can include product seizure, denial of customs clearance for imports, monetary penalties, and — in serious or repeat cases — prosecution. State Licensing Authorities and the Central Licensing Authority can also suspend or cancel an existing license for non-compliance with MDR 2017 conditions, after giving the holder an opportunity to respond.
Common Reasons for Rejection & Compliance Tips
- Incomplete Device Master File or Plant Master File that doesn't follow the MDR 2017 prescribed format.
- Choosing the wrong route — filing a full MD-3 manufacturing application when a simpler Chapter IIIB self-registration would suffice, or vice versa.
- Missing Quality Management System documentation for the manufacturing site.
- Appointing an Indian Authorized Agent who does not already hold a valid MD-42 or manufacturing license before filing MD-14.
- Delayed or incomplete responses to CDSCO deficiency queries, which can stall the timeline significantly.
- Forgetting the 5-year retention fee deadline, which leads to automatic suspension of an otherwise valid license.
Conclusion
CDSCO registration for surgical mask is a role-based process built around a single fact: the product is a Class A medical device. Manufacturers use Form MD-3 to get the manufacturing license on Form MD-5 (or a simpler Chapter IIIB self-registration for non-sterile, non-measuring masks), importers route through Form MD-14 to receive Form MD-15, and wholesalers or distributors apply on Form MD-41 to get Form MD-42. Getting the right form, a complete Device Master File and Plant Master File, and accurate quality documentation in place the first time is what keeps the SUGAM portal timeline short and avoids the deficiency queries that most often delay approval.
Frequently Asked Questions on CDSCO Registration for Surgical Mask
Is a surgical mask a Class A medical device under CDSCO?
Yes. Surgical masks are non-invasive, low-risk devices and are listed as Class A in CDSCO's official risk-classification list, alongside items like bandages and examination gloves.
What form does a manufacturer use to get CDSCO registration for surgical mask?
A manufacturer applies on Form MD-3 with the State Licensing Authority and is granted the manufacturing license on Form MD-5. Non-sterile, non-measuring masks can alternatively use the simpler Chapter IIIB self-registration route on SUGAM.
What is the difference between MD-14 and MD-15?
MD-14 is the application form an Indian Authorized Agent files to import surgical masks into India. MD-15 is the import license granted by the Central Licensing Authority once the application is approved.
What is the difference between MD-41 and MD-42?
MD-41 is the application form for a registration certificate to stock, sell, or distribute surgical masks on a wholesale basis. MD-42 is the certificate granted after the State Licensing Authority approves that application.
Can a foreign manufacturer apply for an import license directly?
No. A foreign manufacturer must appoint an Indian Authorized Agent through a notarised and apostilled Power of Attorney. The agent, who must already hold a wholesale or manufacturing license, files Form MD-14 on their behalf.
Do all surgical mask manufacturers need a full MD-3/MD-5 license?
Not necessarily. If the mask is non-sterile and non-measuring — true for most standard surgical masks — the manufacturer can self-register the device under Chapter IIIB on the SUGAM portal instead of applying for the full MD-3/MD-5 manufacturing license.
How long does CDSCO registration for surgical mask take?
Chapter IIIB self-registration can move in a matter of weeks. A full MD-3/MD-5 manufacturing license and MD-41/MD-42 wholesale registration typically take a few weeks to a couple of months, while an MD-14/MD-15 import license can take up to roughly nine months, largely depending on document completeness and any inspection scheduling.
How much does CDSCO registration for surgical mask cost?
Fees vary by role: import license fees are quoted in USD per overseas site plus a per-product fee, wholesale registration is roughly ₹3,000 per location plus an applicable inspection fee, and Class A manufacturing fees are lower than higher-class device fees. Always confirm current figures on the SUGAM portal.
Does CDSCO registration for surgical mask expire?
No fixed expiry date applies. The registration, license, or certificate remains valid as long as the holder pays the retention fee once every 5 years; missing this deadline suspends the license until the fee (plus a late fee) is paid.
Can I sell imported surgical masks without a separate wholesale license?
Generally no. Even if you hold an import license (MD-15), selling or distributing the masks within India as a wholesaler, stockist, or distributor separately requires an MD-41/MD-42 registration certificate, unless that activity is already covered under your existing license.
Which authority issues each CDSCO license for surgical masks?
Import licenses (MD-14/MD-15) are issued by the Central Licensing Authority at CDSCO headquarters. Manufacturing licenses (MD-3/MD-5) and wholesale registration certificates (MD-41/MD-42) are issued by the respective State Licensing Authority.
Where do I file CDSCO applications for surgical masks?
All CDSCO applications for surgical masks — registration, manufacturing, import, or wholesale — are filed online through CDSCO's SUGAM portal, which routes each form to the correct Central or State Licensing Authority.
