Welcome to SRV Taxcon
SRV Taxcon is an emerging brand in Taxation and Accounting Consulting, specializing in services for start-up businesses.
We offer a single-window solution for Registration and License:
- Our in-house team handles over 50 types of business licenses.
- We provide end-to-end services across India.
- Ensuring smooth and continuous adherence to all legal.
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Medical Device License
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- Medical Device License
MD-5 License for Class-A and B
Benefits
Legal Manufacturing Authorization
Operate your medical device manufacturing unit in India without regulatory hassle.Market Access & Distribution
Sell legally to hospitals, retailers, government tenders, and export markets.Regulatory Compliance
Avoid penalties, product recalls, and seizure by maintaining CDSCO standards.Boost Investor & Buyer Confidence
Enhances brand reputation and trust among customers and stakeholders.Access to Government Procurement
Participate in public healthcare and GeM tenders that mandate MD-5 compliance.
🛠️ Process of Registration
Product Classification & Scope Determination
We help you determine whether your product falls under Class A or B as per CDSCO.Document Preparation & Gap Assessment
Our experts assist in compiling technical files, SOPs, QMS documentation, and ISO compliance.Application Filing via CDSCO SUGAM Portal
Submission of Form MD-3 for approval by the State Licensing Authority.Site Inspection & Compliance Check
CDSCO may inspect the premises and verify quality standards.Grant of MD-5 License
Upon approval, Form MD-5 is issued allowing legal manufacturing of specified devices.
Documents Required
Duly filled Form MD-3 Application
Cover Letter with company profile
Manufacturing Site Details & Plant Layout
Device Master File (DMF) & Plant Master File (PMF)
ISO 13485 Certificate
Quality Management System Documents
List of Equipment & Manufacturing Process Flow
Labels, Packaging & Instruction for Use (IFU)
Declaration of Conformity
Name & Qualification of Technical Staff
What You’ll Get
Experts in CDSCO Medical Device Licensing
ISO 13485 Guidance & SOP Preparation
End-to-End Documentation Support
State-Level Coordination & Follow-ups
Post-License Compliance & Renewal Assistance
Frequently Asked Questions
MD-5 is for manufacturers of Class A & B devices, while MD-9 is for importers of medical devices.
The State Licensing Authority (SLA), under CDSCO, issues the MD-5 license.
Yes, ISO 13485 certification is mandatory to demonstrate QMS compliance.
The license is valid indefinitely, subject to the payment of retention fees every 5 years.
Yes, provided they are manufactured at the same facility and fall under Class A or B.
MD-9 License for Class-C and D
Benefits
Legal Authorization for Import
Legally import and market Class C & D medical devices across India.Access to Indian Market
Tap into India’s growing demand for high-risk medical devices in hospitals and healthcare institutions.Avoid Regulatory Penalties
Stay compliant with CDSCO norms to prevent fines, product seizures, or legal issues.Trusted Brand Image
Increase buyer and healthcare provider confidence with certified and regulated products.Eligibility for Government Tenders
Participate in procurement through platforms like GeM and e-marketplaces.
Process
Product Classification & Compliance Review
We identify device classification (C or D) and check for regulatory readiness.Preparation of Device Master File (DMF) & Plant Master File (PMF)
Our experts help you align with CDSCO documentation standards.Appointment of Indian Authorized Agent
If required, we assist foreign manufacturers with identifying or registering an Indian agent.Application Filing via SUGAM Portal
We submit the MD-6 application for Form MD-9 to CDSCO along with technical and legal documentation.Review & Approval
CDSCO reviews and issues the MD-9 License upon satisfactory verification.
Documents Required
Duly filled Form MD-6 Application
Valid Power of Attorney (POA)
ISO 13485 Certificate (of manufacturer)
Free Sale Certificate (from country of origin)
Device Master File (DMF)
Plant Master File (PMF)
CE/FDA Certification or equivalent approval
Undertaking of Regulatory Compliance
Details of Authorized Indian Agent
Copy of Importer’s Wholesale Drug License
Instruction for Use (IFU), Labels & Packaging Artwork
What You’ll Get
End-to-End Support for MD-9 Import Licensing
Global Experience in CDSCO Compliance
Fast Turnaround Time & Documentation Accuracy
Assistance with Authorized Agent Setup
Post-License Import Compliance Guidance
Frequently Asked Questions
It is required for importing high-risk medical devices (Class C & D) into India.
The manufacturer’s authorized agent in India must apply for the license.
The license is valid perpetually, with retention fees due every 5 years.
Yes, approval from a recognized regulatory body in the country of origin is generally required.
Yes, provided all products are listed and covered in the application.
MD-15 License for Import Medical Device
Benefits
Legal Import Authorization
Allows foreign medical devices to be legally imported and marketed in India.Regulatory Compliance
Meet all CDSCO norms and avoid import delays, penalties, or product seizures.Access to Indian Healthcare Market
Reach hospitals, diagnostic centers, and government procurement programs.Improved Business Credibility
Gain trust among Indian buyers and regulatory authorities with licensed imports.Eligibility for Public Sector Contracts
Required for participating in government tenders and institutional supply.
Process
Regulatory Classification of Device
Confirm device classification (A, B, C, or D) based on CDSCO guidelines.Document Preparation
Our team assists in compiling DMF, PMF, legal, and technical documents.Application Filing on SUGAM Portal
Form MD-14 is submitted via CDSCO’s SUGAM portal along with the prescribed fee.CDSCO Review & Queries (if any)
CDSCO assesses the submission and may raise clarifications, which we help resolve promptly.Issuance of Form MD-15 License
Upon approval, CDSCO grants the MD-15 license to the Indian authorized agent.
Documents Required
Duly filled Form MD-14
Power of Attorney from the foreign manufacturer
ISO 13485 Certificate
Free Sale Certificate (FSC) or equivalent
Device Master File (DMF)
Plant Master File (PMF)
CE/FDA/Health Canada Certificate (if applicable)
Undertaking by the manufacturer
Product Labels, IFU, and Packaging Information
Details of Indian Authorized Agent
Importer’s Drug Wholesale License
What You’ll Get
Expertise in CDSCO Import Licensing
Support for Indian Authorized Agent Setup
Accuracy in Documentation and Timely Filing
Experience with Global Medical Device Manufacturers
Affordable, Transparent Pricing
Frequently Asked Questions
Only the authorized Indian agent of a foreign medical device manufacturer can apply.
Yes, it is mandatory for importing Class A, B, C, or D medical devices into India.
The license is valid perpetually with retention fees payable every five years.
Yes, the Indian agent must hold a valid Drug Wholesale License.
Yes, we handle the entire process—from classification to documentation, filing, and follow-ups.
MD-13 Medical Device Test License
Benefits
Legal Authorization for Testing
Enables companies to legally test or evaluate medical devices before launch.Essential for Clinical Trials & Validation
Required to perform clinical investigations, bio-compatibility, or usability testing.Faster Market Entry
Accelerates the development and approval process of new devices.Supports Innovation
Ideal for R&D, startups, and global companies entering the Indian medical device market.Improves Product Credibility
Demonstrates commitment to regulatory compliance and scientific validation.
Process
Consultation & Classification
Identify the device class and purpose of testing (clinical, demo, or analytical).Document Compilation
SRV Taxcon assists in preparing technical, administrative, and protocol documents.Application Submission
Submit Form MD-12 with prescribed fee via CDSCO’s SUGAM portal.CDSCO Review
Authorities assess the application. Any queries are promptly handled by our team.Grant of License in Form MD-13
Upon approval, CDSCO issues the MD-13 License authorizing testing activities.
Documents Required
Duly filled Form MD-12 application
Purpose of testing or investigation
Device description and specifications
Test protocol or clinical trial protocol (if applicable)
Ethics Committee approval (for clinical trials)
Undertaking regarding non-commercial use
Details of testing site/lab or institution
CE/FDA/ISO certificates (if applicable)
Manufacturer’s Authorization Letter (for importers)
What You’ll Get
Experts in CDSCO Licensing & SUGAM Portal
Specialized Support for Clinical & Non-Clinical Testing
Transparent Process & Timely Delivery
Compliance with India’s Medical Device Regulations
End-to-End Documentation & Regulatory Handling
Frequently Asked Questions
It is used for importing or manufacturing medical devices for testing, evaluation, or clinical investigation—not for commercial sale.
Manufacturers, importers, CROs, or institutions intending to test or clinically trial a device.
The license is valid for 3 years or as specified, depending on the purpose of testing.
No. Devices imported or manufactured under this license cannot be sold.
Yes. We assist with protocol preparation, ethics approvals, and CDSCO compliance.
WHO GMP Compliance
Benefits
Global Market Acceptance
Enhances product credibility and opens doors to international markets.Compliance with International Norms
Fulfills regulatory requirements for exports, especially in countries recognizing WHO-GMP.Improved Product Quality & Safety
Ensures consistent quality control throughout production.Boosts Business Reputation
Increases trust among buyers, regulators, and stakeholders.Supports Licensing & Tender Eligibility
Required for government contracts, public tenders, and large-scale buyers.
🛠️ Process of Registration
Initial Assessment
Evaluation of current manufacturing practices and facility readiness.Gap Analysis & Documentation
Identification of gaps in SOPs, records, and quality systems; guidance on corrective actions.Facility Audit & Process Review
Internal audit to prepare for inspection by competent authority.Application Submission
Submit application to the State Drug Authority or CDSCO (if applicable) for certification.GMP Inspection
Inspection by government officials to verify WHO-GMP compliance.Certification Issued
Upon successful inspection, WHO-GMP Certificate is granted.
Documents Required
Company profile
List of equipment and machinery
Manufacturing site layout
Standard Operating Procedures (SOPs)
Quality control & assurance protocols
Details of production staff and their qualifications
Batch manufacturing and distribution records
Validation protocols and records
Product testing and stability data
Regulatory licenses (Drug License, FSSAI, etc.)
What You’ll Get
Expert Team with Regulatory Experience
Facility Audit & Documentation Support
Assistance in Facing GMP Inspection
Customized SOPs & Quality Control Systems
PAN India Service Coverage
Quick Turnaround with End-to-End Support
Frequently Asked Questions
Manufacturers of pharmaceuticals, medical devices, cosmetics, and nutraceuticals looking to export or improve product credibility.
Yes, in many countries, WHO-GMP compliance is mandatory to import pharmaceutical and health-related products.
Typically 30 to 90 days, depending on the readiness of your facility and documentation.
Usually valid for 3 years, subject to periodic inspections.
Absolutely. We draft and customize SOPs tailored to your manufacturing process.
Client Testimonials
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Product Manager
Rajeev S.
Frontend Team Lead
Emily D.
Backend Engineer,
Ahmed K.
CTO, TechNova
Sophia R.
Full Stack Developer
John M.
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