Trusted by 200+ Global Brands • 25,000+ Projects Completed
☎ +91 9627064810 ☎ +919990503885 ✉ sales@diligencecertification.com
CDSCO & medical device licences — expert help
Get Free Quote ☎ Call Now
CDSCO • Medical devices • Drugs & cosmetics

CDSCO & Medical Device
Licences — Import,
Manufacture & Distribution

One team for notified devices (import, manufacture, wholesale, retail, test licences, FSC) and for pharma & cosmetic licensing. Full MD form map • Drugs & cosmetics • Endorsements, PAC & renewals.

Warning Operating without required CDSCO approvals can lead to enforcement action, market bans, and supply chain disruption. Get compliant before regulators act.
WhatsApp Now ☎ +91 999 050 3885
25,000+Projects Done
200+Global Brands
100+Expert Staff
25+Years Experience

Get Free Consultation

Our CDSCO experts respond within 60 minutes

🔒 Confidential ✔ No Spam ⚡ 60 Min Response
Trusted By Leading Brands Worldwide
Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client Client
High-intent: import

MD-14 & MD-15 import at a glance

Importers of notified Class A–D devices need a CDSCO import licence (MD-15) applied for via Form MD-14, with the right registration, grouping, and technical file. Full form definitions: licence catalogue · Document list: MD-15 checklist.

Importer support

  • Dossier gap analysis & MD-15 filing
  • Endorsements, retention & product-range additions
  • PAC / variations & CDSCO queries
  • IVD and non-IVD pathways

Also planning manufacture or wholesale?

Many setups need MD-41/42 (wholesale) or MD-3/5 or MD-7/9 (manufacture) in addition to import. We map which combination applies before you file.

Free route check →
Illustration: medical device import pathway and regulatory documentation
Why It Matters

CDSCO Compliance Isn't Optional —
It's a Market Gate

Drugs, cosmetics, and medical devices in India are regulated under the Drugs and Cosmetics Act. Without the right CDSCO registration or license, you cannot legally manufacture, import, or distribute in the Indian market.

Import & Distribution Blocks

Unregistered or non-compliant products can be stopped at ports or blocked from lawful distribution channels.

₹

Financial & Legal Exposure

Penalties, recalls, and litigation from regulatory non-compliance can erode margin and brand trust.

Lost Market Access

Hospitals, distributors, and e-commerce channels increasingly require valid CDSCO documentation.

Reputation & Recall Risk

Quality and safety issues without proper licensing amplify recall and reputational damage.

⚠ Don't wait for a regulatory notice: CDSCO and state drug control authorities are actively enforcing compliance across pharmaceuticals, cosmetics, and medical devices.
Illustration: moving from compliance risk to approved regulatory status
Check Your CDSCO Path →
Regulatory Scope

Types of CDSCO License in India

CDSCO is the apex authority for import, manufacture, and distribution of drugs, cosmetics, and medical devices. The right route depends on your product and role in the supply chain.

Drug License

Manufacturing, wholesale, import, and distribution of pharmaceutical products as per the Drugs and Cosmetics Act and rules. Includes schedules and conditions specific to dosage forms and activities.

Pharmaceuticals

Cosmetic License

Manufacture, import, and sale of cosmetics with labeling and safety compliance. Registration and licensing requirements align with notified cosmetic rules and product categories.

Cosmetics

Medical Devices

All major activities under the Medical Device Rules, 2017 — see the step-by-step licence map (MD-15 through FSC). Includes device registration and IVD.

MD Rules 2017

Not Sure Which License?

We help with classification, device grouping, and the correct CDSCO application route so you avoid rework and delays.

Get Free Guidance →
Medical Device Licences

CDSCO Licence Map for Medical Devices

Under the Medical Device Rules, 2017, the CDSCO requires the following licences and permissions for manufacturing, import, and distribution of medical devices in India. The correct application form and authority depend on the device class (A, B, C, D), business role, and proposed activity.

MD-14 & MD-15 — Import

Application form (MD-14) and licence grant (MD-15) to import notified medical devices (Classes A, B, C & D) into India.

Importers

MD-3 & MD-5 — Manufacture A & B

State authority application (MD-3) and licence (MD-5) for manufacture and sale of Class A & B devices at approved sites. Requires QMS and post-market surveillance compliance.

Manufacturing

MD-7 & MD-9 — Manufacture C & D

Central CDSCO application (MD-7) and licence (MD-9) to manufacture & sell Class C & D devices. Requires detailed technical file, scrutiny, and QMS audit.

Manufacturing

MD-41 & MD-42 — Wholesale

Application form (MD-41) and licence grant (MD-42) to sell, stock, or distribute medical devices as a wholesaler (Classes A, B, C & D).

Distributors

MD-42 — Retail A & B

Licence to sell by retail Class A and B devices via pharmacies or medical shops (state authority route). Other retail forms (e.g. MD-41) apply to higher classes.

Retail

MD-13 — Test / Trial

Licence to manufacture or import devices for evaluation, demonstration, clinical investigation, or training.

R&D / QA

Free Sale Certificate (FSC)

Certificate of Free Sale from CDSCO for devices either manufactured or lawfully sold in India — required for export and some overseas registrations.

Export

Unsure which licence?

Most companies need multiple licences or guidance with combinations (e.g. MD-15 + MD-41/42). We’ll clarify the route as per device class and business model.

Request Callback →
Understanding CDSCO

CDSCO Registration — An Overview

Growing your pharmaceutical or medical device business in India requires the right CDSCO registration or license. The Central Drugs Standard Control Organization regulates medical devices and pharmaceuticals under the Drugs and Cosmetics Act, 1940, and the Rules of 1945.

Manufacturers, importers, and authorized agents dealing in medical devices, pharmaceuticals, cosmetics, or diagnostics must align with CDSCO and state drug control requirements. Diligence Certifications supports classification, dossier preparation, application filing, and query resolution with consultants experienced in Indian regulatory practice.

Get a Free Consultation
Illustration: national healthcare regulator and compliance assurance
Eligibility

Who Typically Applies?

Applies to import (MD-14/15), wholesale (MD-41/42), and manufacture (MD-3/5 or MD-7/9) — authorities look at entity type, agent arrangements, and existing licences. Common profiles:

Importer / marketer

Companies importing finished devices for sale in India, often with an Indian authorized agent or subsidiary as required.

Wholesaler & distributor

Entities that hold or seek wholesale licenses for medical devices and need import authorization for notified categories.

Manufacturer (import + Mfg.)

Manufacturers importing components or finished goods may need both manufacturing and import permissions as per activity.

Authorized Indian agent

Indian agents acting for foreign manufacturers often coordinate registration, import license, and compliance on behalf of the overseas principal.

In-vitro diagnostics (IVD)

IVD device import follows CDSCO requirements for diagnostic products used on specimens (e.g. blood, urine). Dossiers commonly reference QMS evidence (such as ISO 13485), conformity documentation, authorized agent details, and post-market surveillance where applicable. We help align your technical file and import application with current expectations.

Why License

Benefits of a Valid Licence

A valid CDSCO-aligned license supports compliance, quality, and market access for drugs and medical devices.

Regulatory Compliance

Demonstrate adherence to national requirements and align with global expectations (e.g. quality systems referenced by major regulators).

Quality Assurance

Licensing pathways encourage robust quality control and documentation, supporting product consistency and reliability.

Market Access

Lawfully manufacture, import, and distribute in regulated channels with valid approvals and registrations.

Consumer Trust

Healthcare professionals and buyers increasingly expect transparent regulatory status for drugs and devices.

Competitive Advantage

Licensed players stand apart from informal operators in tenders, hospital supply, and retail.

Risk Mitigation

Reduce exposure to enforcement, recalls, and supply disruption from non-compliance.

Risk Classification

Medical Device Products by Class (Risk)

Illustrative examples commonly referenced for risk classes; final classification is based on intended use and applicable rules.

Class A
Low risk
  • Surgical & nitrile gloves, masks & gown
  • Thermometer, tongue depressors
  • OT table & light, surgical microscope
  • Scissors & forceps (general)
Class B
Low–moderate risk
  • Syringes, needles, infusion sets
  • Oxygen concentrator, glucometer strips
  • Sphygmomanometer, fetal Doppler
  • Hearing aid, spirometer
Class C
Moderate–high risk
  • Implants, bone plates & screws
  • Patient monitor & ECG, X-ray
  • Infusion & syringe pumps, catheters
  • CPAP/BPAP, haemodialysis catheter
Class D
High risk
  • Implantable pacemaker pulse generator
  • Heart valve, ventricular bypass device
  • Carotid sinus nerve stimulator
  • Specialized implantable / critical devices
How we work

Three Steps With Our Team

Same process shape for import, manufacture, or distribution licences — only the forms and authority (CDSCO vs state) change.

1

Scope & licence map

We confirm device class, your role in the supply chain, and which MD forms (or drug/cosmetic routes) you actually need.

2

Dossier & gap-fix

Checklists tailored to your path — QMS, PoA, site documents, labels/IFU, and any FSC/MA from the country of origin.

3

File, query, approve

Submit to CDSCO or state SLA, answer queries, then hold the licence or registration you need to operate — e.g. MD-15 for import, MD-42 for wholesale, etc.

Step by Step

How to Apply for CDSCO Registration?

High-level steps apply across pathways; specifics depend on drugs, cosmetics, or medical devices. Pick a track below for tailored steps and typical documents.

01

Application Preparation

Compile product, site, and quality information as per the applicable drug rules and schedule.

02

Submission to Authority

File the complete application with CDSCO / state licensing authority as per jurisdiction and activity.

03

Assessment & Inspection

Authorities review dossiers; inspections may be scheduled for manufacturing and wholesale premises.

04

Query Resolution

Respond to clarifications on formulations, stability, labels, or quality systems promptly.

05

License Grant

On satisfaction of conditions, manufacturing / wholesale / import licenses are issued.

Documents (typical)

  • ID proof & address proof of applicant / entity
  • Manufacturing or wholesale license (as applicable)
  • Layout, water, and waste system details (manufacturing)
  • Quality manual & personnel qualifications
  • Product list, formulations, and stability data (as required)
  • Undertaking / government-authority documents where notified
01

Product & Ingredient Review

Align formulations and labels with cosmetic rules and notified standards.

02

Dossier & Application

Prepare application for manufacture, import, or registration as per category.

03

Authority Review

CDSCO / state authorities review safety, labeling, and responsible person details.

04

Clarifications

Address queries on ingredients, claims, GMP, or PIF documentation.

05

Approval & License

Grant of license or registration certificate for lawful trade in India.

Documents (typical)

  • ID & address proof
  • Manufacturing / import license application forms
  • Product information, labels, and ingredient lists
  • GMP / site details where applicable
  • Undertaking / government-authority documents where notified
01

Classification & Grouping

Determine the correct risk class and device family for your intended use.

02

Technical Documentation

Prepare design, risk, clinical evaluation (where applicable), and labeling as per requirements.

03

Application Submission

Submit online application with fees and supporting documents to CDSCO.

04

Review & Queries

Respond to CDSCO queries on tests, standards, or post-market surveillance plans.

05

Registration / Import License

Receive registration certificate or license to import/manufacture as approved.

Documents (typical)

  • ID proof & address proof (applicant / agent)
  • Power of Attorney (apostille / notarization as applicable)
  • Manufacturing site license & Free Sale / Marketing Authorization from reference country
  • ISO 13485 and CE / QMS evidence (as applicable to device)
  • Declaration of Conformity; plant / device master file excerpts
  • Undertaking from authorized agent where required
  • Labels, IFU, and risk / essential principles documentation

See also the MD-15 document checklist below for import-focused lists.

Checklist

Documents Often Required for MD-15 / Import

Requirements vary by device class and origin country. Your CDSCO officer may request additional items. Use this as a working checklist with our team.

Illustration: technical dossier, checklist, and regulatory documents for import licence

Legal & authorization

  • Power of Attorney — apostilled / notarized per guidance, with agent undertaking
  • Constitution documents of Indian authorized agent / applicant
  • Appointment of authorized signatory and board resolution (if applicable)

Manufacturing & market proof

  • Self-attested manufacturing license from country of origin (where applicable)
  • Free Sale Certificate or Marketing Authorization — apostilled / notarized
  • Overseas site registration from competent authority

Quality & regulatory evidence

  • ISO 13485 certificate of actual manufacturer (notarized copy)
  • CE full quality assurance / type-examination / design dossier evidence (as applicable)
  • Recent inspection or audit report (e.g. notified body or national authority, typically within last 3 years)
  • Declaration of Conformity (notarized)

Technical

  • Plant Master File (PMF) and Device Master File (DMF) excerpts as required
  • Labels, IFU, and grouping rationale for the application

Validity & renewal: Medical device import licenses are typically issued with a 5-year validity for Class A–D (subject to CDSCO conditions). Renewal usually relies on the prior license and fee challan plus any updated documents — we help plan ahead so imports are not interrupted.

Ready to File or Unblock a Query?

Free consultation • Fast response • Clear next steps — not generic advice

Get Free Quote ☎ Get a Call Back
What Our Clients Say

Trusted By Healthcare & Pharma Brands

See what our clients have to say about working with Diligence Certifications on regulatory projects.

Client Testimonial
Client Testimonial
Client Testimonial
Client Testimonial
Client Testimonial
Client Testimonial
Client Testimonial
Client Testimonial
On the Ground

Regulatory Site Visits

Photos from client facilities where we support audits and compliance readiness — real sites, real regulatory work.

Compliance site visit at client facility
Compliance site visit at client facility
Compliance site visit at client facility
Compliance site visit at client facility
Compliance site visit at PEM Fasteners Malaysia
Compliance site visit at DSR factory
Why Diligence

Your Expert Partner In
CDSCO & Beyond

Drugs, cosmetics, and medical devices demand accurate dossiers, clear classification, and disciplined follow-up with CDSCO and state authorities.

Structured Dossiers. Fewer Rework Cycles.

We align technical files and applications with what CDSCO reviewers expect, reducing back-and-forth on queries.

End-to-End Regulatory Support

From device classification and drug licensing routes to import documentation and post-approval changes, we stay with you through the lifecycle.

Coordination With State & Central

We help navigate both CDSCO and state drug control interfaces where your application requires dual alignment.

Trusted Across Healthcare Verticals

Manufacturers, importers, and brand owners rely on us for pragmatic regulatory execution, not generic checklists.

Beyond First Approval

Variations, renewals, and post-market documentation — we help you stay current as rules and products evolve.

Why Businesses
Trust Us

✓
Faster ApprovalsWe know how to avoid delays and keep your licence applications on track.
✓
Technical ExpertiseEvery application handled by professionals who understand standards.
✓
Dedicated SupportOne point of contact, full accountability throughout the process.
✓
Affordable & TransparentNo hidden costs, no surprises — just results and clear pricing.
✓
CDSCO, BIS, ISO & MoreIntegrated compliance support for Indian and global market requirements.
Start your licence application →
Licences & CDSCO filings

Free Consultation — Same-Day Callback

Tell us about your drugs, cosmetics, or medical devices. We’ll map the right CDSCO route and document checklist for your case.

Our team reviews your product category, business activity, and current approvals to give you a clear route, likely timeline, and practical document plan before filing.

  • Import, manufacture, wholesale, and retail pathway mapping
  • Form-wise checklist for MD-14/15, MD-3/5, MD-7/9, MD-41/42, and related routes
  • Gap analysis for PMF/DMF, labels, IFU, PoA, and QMS records
  • Support for CDSCO/SLA queries, updates, and post-approval changes
WhatsApp Us +91 999 050 3885
24×7 support Free consultation 200+ global clients

Get Best Price & Timeline

Same experts as the top form — we reply promptly

🔒 Confidential ✔ No Spam ⚡ 60 Min Response
Frequently Asked Questions

Got Questions? We Have Answers

Everything you need to know about CDSCO registration — answered by our experts.

CDSCO (Central Drugs Standard Control Organization) is India’s national regulatory authority for pharmaceuticals and medical devices under the Ministry of Health. Registration or licensing ensures drugs, cosmetics, and devices meet safety, efficacy, and quality standards before they can be sold or imported legally.
Common categories include drug manufacturing / wholesale / import licenses, cosmetic manufacture / import licenses, and medical device registration or import licenses by risk class. The exact route depends on your product and role (manufacturer, importer, marketer).
Devices are classified into risk classes A through D (low to high risk). Classification drives documentation depth, review timelines, and whether clinical data is required. We help you assign the correct class based on intended use and applicable rules.
Timelines vary by product complexity, dossier quality, and query cycles. A complete, well-structured application typically moves faster. We focus on first-time-right documentation and faster query turnaround.
Typical items include ID and address proof, undertakings, manufacturing or wholesale licenses where applicable, technical documentation for devices, and site-specific approvals as relevant. See the Process tabs above for track-specific lists.
Yes. Importers and overseas manufacturers must meet Indian representative, labeling, and quality requirements as applicable. We help structure the application for import and manufacturing scenarios.
Yes. We assist with CDSCO queries, variations, renewals, and updates to registrations or licenses as your products or sites change.
MD-3 is used to apply for a licence to manufacture medical devices of Class A or Class B in India (state licensing authority). MD-15 is the import licence route for bringing notified devices into India. They are not interchangeable — choose based on whether you manufacture domestically or import.
Often yes for wholesale activity: MD-15 authorizes import, while MD-41 & MD-42 covers selling, stocking, or distributing devices wholesale in India as per the Medical Device Rules. We map the combination for your supply chain.
Yes. IVD products have their own technical and labeling expectations. We help compile QMS evidence, conformity documentation, agent details, and post-market elements in line with CDSCO requirements for your device category.
Medical device import licenses are commonly granted with five-year validity for Class A through D, subject to CDSCO conditions. Renewal often uses the previous license and fee challan plus any updates requested by the authority — we help you plan timelines so imports are not disrupted.
☎ Call Now WhatsApp