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Short answer:
A CDSCO licensing consultant, such as TRACC Global, prepares and files the applications a medical device company needs under the Medical Devices Rules, 2017. This mainly includes the import licence (Form MD-14 leading to MD-15) and manufacturing licences (MD-5 or MD-9), while handling subsequent regulatory queries.
The ten firms below, including TRACC Global, all publish CDSCO device services. Choose your partner based on your device class, applicant type, and whether they can act as your Indian Authorised Agent. Note that no consultant can guarantee approval; CDSCO holds the final authority.
How we selected these consultants
We started from the firms in the previous version of this article and from firms that appear for searches such as “CDSCO consultant” and “CDSCO license consultant”. A firm was included only if it met all four criteria:
- Published CDSCO medical device services: a service page or guide covering import licences, manufacturing licences or registration under the Medical Devices Rules, 2017.
- Identifiable business: a public website or directory listing with a company name and location or contact route.
- Device specialisation: evidence of medical device or IVD work, not only drug or general business licensing.
- Transparency: enough public detail to describe what the firm does without guessing.
We did not interview clients, review fees, or verify approval outcomes, so this is a comparison, not a ranking. Four firms named in the earlier version were removed because we could not find public evidence of CDSCO medical device licensing services. For a wider view that includes quality systems and plant set-up, see our list of broader medical device consulting firms.
Top 10 CDSCO Licensing Consultants in India: 2026 - 2027 Comparison
| Consultant | Base (as published) | Core CDSCO Services | Also Covers | May Suit |
|---|---|---|---|---|
| TRACC Global | Gurugram; serves pan-India and international clients | MD-14/MD-15 import, MD-3 to MD-10 manufacturing, Indian Authorised Agent, IVD, MD-42, SaMD | CE, US FDA 510(k), UKCA, SFDA; ISO 13485; plant projects | Foreign manufacturers and Indian plants wanting one team for licence and QMS |
| Agile Regulatory | Delhi NCR | MD-14/MD-15 import, manufacturer registration | BIS, ISO, wider business licensing | Delhi NCR importers wanting a local filing partner |
| ASC Group | Noida / New Delhi; multi-city | CDSCO medical device registration and licensing | Large compliance practice (since 1995, per the firm) | Companies that want CDSCO alongside other corporate compliance |
| CliniExperts | India | Importer and manufacturer licences, authorised agent support, IVD kits | Drugs, clinical research | IVD importers and foreign brands needing agent support |
| Corpseed | India | MD-14/MD-15 import, MD-42 seller registration | BIS, EPR, general compliance | Traders and distributors needing MD-42 plus other filings |
| DKNSB Medical Device Consultants | Bawana, New Delhi | Import registration, manufacturing licence applications | CE / EU MDR, FDA 510(k), ISO 13485, MDSAP | Small and mid-size manufacturers going India plus export |
| Freyr Solutions | Global, with India operations | End-to-end CDSCO device registration (published case studies) | Multi-market regulatory affairs | Multinationals filing in many markets at once |
| Maven Profcon Services LLP | India | Import licence support EDITOR: confirm on firm’s site | — | Importers |
| Morulaa HealthTech | India | Indian Authorised Agent and device registration for foreign manufacturers | Regulatory knowledge hub in several languages | Overseas manufacturers entering India |
| Operon Strategist | Pune, Maharashtra | Registration, import and manufacturing licences, SaMD | Plant layout, QMS, CE, FDA | Start-up manufacturers setting up a plant |
Notable CDSCO Consulting Firms in India (Detailed Profiles)
Each profile follows the same format so you can compare firms quickly. Phone numbers and email addresses change often, so we link each firm’s official website; use the contact page there.
1. TRACC Global (India's Leading CDSCO & QMS Experts)
Best for: Foreign manufacturers and Indian plants that want CDSCO licensing, Indian Authorized Agent (IAA) services, and QMS setup handled seamlessly by one expert team.
Location: Sector 45, Gurugram, Haryana (Serving clients across India and internationally).
Core CDSCO services: Product classification, MD-14/MD-15 import licences, MD-3 to MD-10 manufacturing licences, Indian Authorized Agent (IAA) support, IVD registration, MD-42 registration, clinical investigation permissions, and online portal filings (including SUGAM).
Also covers: CE marking, US FDA 510(k), UKCA, SFDA, ISO 13485 quality systems, and turnkey plant projects.
The TRACC advantage: Led by a certified ISO 13485 Lead Auditor, TRACC runs strict pre-submission mock audits to minimize CDSCO queries, handle deficiency letters, and ensure faster approvals. Successfully guided 200+ domestic and international medical device companies.
Connect with us: Visit traccglobal.com | Call/WhatsApp: +91 88688 86774 (Contact us today for a free, customized cost estimate based on your device class).
2. Agile Regulatory
- Website: agileregulatory.com
- Location: Delhi NCR (runs separate pages for Delhi, Noida and Gurugram).
- Core CDSCO services: MD-14/MD-15 import licence, medical device manufacturer registration.
- Also covers: BIS, ISO and general business licensing.
- Company-reported figures: 12,000+ businesses served.
- Best for: Delhi NCR importers who want a local filing partner.
3. ASC Group
- Website: ascgroup.in
- Location: Corporate office in Noida, registered office in New Delhi, with offices in other Indian cities and abroad.
- Core CDSCO services: CDSCO medical device registration and licensing.
- Also covers: Corporate, tax and trade compliance (named in our earlier version as EXIM Advisory).
- Company-reported figures: Operating since 1995, 1,000+ clients.
- Best for: Companies that want CDSCO work alongside wider corporate compliance.
4. CliniExperts
- Website: cliniexperts.com
- Location: India.
- Core CDSCO services: Importer and manufacturer licences, authorised agent support, IVD kit import permissions.
- Also covers: Drug approvals and clinical research.
- Best for: IVD importers and foreign brands that need agent support.
5. Corpseed
- Website: corpseed.com
- Location: India.
- Core CDSCO services: MD-14/MD-15 import permissions, MD-42 registration for wholesalers and retailers.
- Also covers: BIS, EPR and general compliance.
- Best for: Traders and distributors who need MD-42 plus other registrations.
6. DKNSB Medical Device Consultants
- Website: EDITOR: add official site (public profile: directory listing)
- Location: Bawana, New Delhi.
- Core CDSCO services: Import registration, MD form submissions, manufacturing licence applications.
- Also covers: CE / EU MDR, FDA 510(k), ISO 13485, MDSAP.
- Company-reported figures: About 20 years of device experience; team of 1–50.
- Best for: Small and mid-size manufacturers selling in India and abroad.
7. Freyr Solutions
- Website: freyrsolutions.com
- Location: Global, with India operations.
- Core CDSCO services: End-to-end device registration, shown in published CDSCO case studies.
- Also covers: Regulatory affairs in many markets.
- Best for: Multinationals filing in several countries at once.
8. Maven Profcon Services LLP
- Website: EDITOR: confirm official site
- Location: India.
- Core CDSCO services: Medical device import licence support. EDITOR: confirm on the firm’s site, or replace this entry
- Best for: Importers.
9. Morulaa HealthTech
- Website: morulaa.com
- Location: India.
- Core CDSCO services: Indian Authorised Agent (IAA) and device registration for foreign manufacturers.
- Also covers: Regulatory guidance published in several languages.
- Best for: Overseas manufacturers entering India.
10. Operon Strategist
- Website: operonstrategist.com
- Location: Pune, Maharashtra.
- Core CDSCO services: Registration, import and manufacturing licences, software as a medical device.
- Also covers: Plant layout, QMS, CE, US FDA.
- Best for: First-time manufacturers who also need a facility designed.
What does a CDSCO licensing consultant do?
A CDSCO consultant turns your product and company information into an application CDSCO can approve. Typical work includes:
- Confirming the device’s risk class (A to D) and the right licence pathway.
- Preparing the Device Master File and Plant Master File.
- Collecting and checking certificates: ISO 13485, free sale or marketing authorisation, declaration of conformity, Power of Attorney.
- Filing on CDSCO’s online system for medical devices and answering queries. (Drug and other CDSCO applications use the SUGAM portal.)
- Supporting inspections for manufacturing licences.
- Post-approval work: endorsements for new products, licence retention, changes and vigilance reporting.
A consultant is not a regulator and cannot speed up CDSCO’s review or promise approval. The licence is issued in the applicant’s name, and the applicant stays legally responsible for the device.
CDSCO medical device licences: the basics
The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), regulates medical devices under the Medical Devices Rules, 2017. Devices are grouped by risk into Class A (low), B (low to moderate), C (moderate to high) and D (high).
Registration has given way to licensing. When all medical devices were brought under regulation from 1 April 2020, CDSCO allowed a period of registration. Class A and B devices moved to the licensing regime on 1 October 2022, and Class C and D devices on 1 October 2023 (CDSCO guidance). If an article still says “registration is enough”, it is out of date.
| Activity | Device Class | Application → Licence | Who Grants It |
|---|---|---|---|
| Manufacture | A, B | MD-3 → MD-5 (loan licence: MD-4 → MD-6) | State Licensing Authority |
| Manufacture | C, D | MD-7 → MD-9 (loan licence: MD-8 → MD-10) | Central Licensing Authority (CDSCO) |
| Import | A to D | MD-14 → MD-15 | Central Licensing Authority (CDSCO) |
| Test licence (manufacture / import) | Any | MD-12 → MD-13 / MD-16 → MD-17 | Licensing authority |
| Clinical investigation | Investigational devices | MD-22 → MD-23 | Central Licensing Authority |
| Sell, stock, distribute | Any | MD-42 registration (if no Rule 87(1) licence) | State authority |
For pathway detail, see our guides to the CDSCO import licence for medical devices and the manufacturing licence process.
Foreign manufacturers: the Indian Authorised Agent
A foreign manufacturer cannot apply for an Indian import licence itself. It must appoint an Indian Authorised Agent, who files Form MD-14 and holds the MD-15 licence. Under CDSCO’s import licence checklist, the agent must:
- Hold a wholesale licence, a manufacturing licence, or an MD-42 registration.
- Have a Power of Attorney from the manufacturer, authenticated in India by a First Class Magistrate or in the origin country by the Indian Embassy or apostille.
- Give the undertakings set out in the Fourth Schedule of the Rules.
Some consultants act as the agent themselves; others work with your distributor. Ask which model a firm uses, because the agent is accountable to CDSCO for the device. TRACC Global acts as an Indian Authorised Agent for global manufacturers and holds the wholesale licence the Rules require, so your imports stay compliant.
Documents you will usually need
For an import licence, CDSCO’s checklist asks for:
- Covering letter, Form MD-14 and proof of fee payment.
- Power of Attorney and the agent’s undertaking, plus the agent’s licence or MD-42 registration.
- Free sale or marketing authorisation from the country of origin, or from the USA, UK, EU, Canada, Japan or Australia, notarised.
- Quality management system certificate (usually ISO 13485), CE or equivalent certificates, and a declaration of conformity.
- Plant Master File and Device Master File, including risk analysis, verification and validation, labelling, clinical evidence and post-market surveillance.
- The latest overseas inspection report from the last three years, if any.
Manufacturing applications follow the same logic, with site documents and an inspection of the plant.
How to choose a CDSCO licensing consultant
Use these seven checks on every shortlist, including us.
- Domain specialisation: ask what share of the team’s work is medical devices or IVDs rather than drugs, food or general licensing.
- Track record in your class: ask for anonymised examples in your device class and applicant type.
- End-to-end scope: classification, dossier, filing, queries, inspection and post-approval.
- Written timelines and fees: separate government fees from professional fees.
- Agent model: can the firm be your Indian Authorised Agent, and does it hold the licence the Rules require?
- Response speed: who answers CDSCO queries, and how fast?
- Verifiable references: a client you can call beats a testimonial on a website.
Signs of a good consultant
- Asks detailed product questions before quoting.
- Knows CDSCO’s online medical device system and current checklists.
- Gives a written breakdown of timelines and fees.
- Can show device-specific case examples.
- Offers post-approval support.
Red flags
- Guarantees approval or a fixed approval date.
- Cannot explain your device’s class.
- Quotes a price without seeing your documents.
- Has no visible track record or references.
- Stops responding after submission.
Looking for a CDSCO consultant in Delhi NCR?
Many consultants are in Delhi, Noida and Gurugram because CDSCO’s headquarters is in New Delhi. Location matters less than it used to, since applications are filed online. It still helps for document signing, notarisation and plant visits. In the table above, TRACC Global (Gurugram), Agile Regulatory (Delhi NCR), ASC Group (Noida/New Delhi) and DKNSB (New Delhi) publish Delhi NCR bases. TRACC also works with clients outside Delhi NCR and outside India.
What affects timelines and fees
We do not publish fixed timelines or prices, because they depend on factors no consultant controls. Expect these to drive both:
- Device class and whether it has a predicate.
- Number of manufacturing sites and products in one application.
- Completeness of your Device Master File and certificates.
- Number and depth of CDSCO queries.
- Inspection scheduling for manufacturing licences.
- Government fees, which are set in the Second Schedule of the Medical Devices Rules, 2017 and charged per site and per device.
Professional fees vary with scope. A quote for classification and filing only will differ from one that includes agent services, inspection support and retention.
Common mistakes that slow approval
- Filing before classification is settled. A wrong class means the wrong form and authority.
- Downgrading a device’s class to reach a simpler pathway. CDSCO will query it.
- Unattested or mismatched documents between the certificates, labels and Device Master File.
- Slow query responses. Assign an owner on day one.
- Ignoring post-approval duties such as endorsements for new products and licence retention.
More examples are in our guide to the mistakes that delay CDSCO approval.
Beyond medical devices
CDSCO also regulates drugs, clinical trials and the import of cosmetics, each under its own rules. A firm that is strong on devices may not file drug or cosmetic applications, and the reverse. If your portfolio spans several, ask for named specialists for each.
Ready to Start Your CDSCO Approval?
Whether you need a CDSCO Medical Device Registration, an import license, or a manufacturing license — getting the right expert on your side from day one is the smartest move. TraccGlobal offers a free consultation to review your product, discuss classification, and outline a clear regulatory roadmap.
Talk to a TraccGlobal Expert →Frequently Asked Questions
What does a CDSCO licensing consultant do?
A CDSCO licensing consultant prepares and files your medical device licence application and handles CDSCO’s queries. That covers classification, the Device and Plant Master Files, filing on CDSCO’s online system and inspection support. Approval stays CDSCO’s decision.
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