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- A medical device manufacturing license in India is a regulatory approval that allows manufacturers to produce medical devices legally under Central Drugs Standard Control Organisation (CDSCO) oversight.
- Application involves filing appropriate forms (such as Form MD-3/MD-5 for Class A & B, or Form MD-7/MD-9 for Class C & D), submitting technical documentation and ensuring site readiness.
- A strong Quality Management System (QMS) aligned with ISO 13485, a Device Master File (DMF) and Plant Master File (PMF) are fundamental prerequisites for the manufacturing license.
- Mis-classification of device risk class, incomplete documentation or failing site inspection frequently cause delays or denial of the manufacturing license.
- Engaging a specialist regulatory consultancy (such as Diligence Certifications) ensures that the manufacturing license process becomes a strategic asset rather than a regulatory hurdle.
Introduction
A mid-sized medical-device manufacturer in Bengaluru invested in tooling and hired staff, intending to produce a Class B infusion set. They proceeded to manufacture and supply units—but a surprise visit from the State Licensing Authority triggered a pause. The reason: they lacked the required manufacturing license for medical devices under CDSCO rules. The business halted, production schedule slipped and cost escalated. Once they engaged expert assistance to obtain the manufacturing license for medical devices legally, the factory restarted and future contracts were unfrozen.
This experience reveals how critical the medical device manufacturing license is: not just a legal checkbox, but a strategic foundation for production, market access and investor confidence. In this guide you will find a thorough explanation of what the license means, why it matters, how to apply, what the cost and timeline are, and how a specialist consultancy like Diligence Certifications helps navigate the journey with confidence.
What the Manufacturing Licence for Medical Devices Means
The term medical device manufacturing license refers to authorisation granted to a manufacturing entity to produce specified categories of medical devices. Under the Medical Devices Rules, 2017, the regulation sets out different forms depending on the device’s risk class: for Class A & B devices the license is typically issued via Form MD-5 following an application in Form MD-3. For higher-risk devices (Class C & D), the process uses Form MD-7 / MD-9.
In simple language: if your business manufactures devices—whether simple or complex—you must obtain a manufacturing license for medical devices. Without it, production and commercial distribution may be deemed illegal, exposing you to regulatory enforcement, blocked shipments or contract losses.
Why a Manufacturing License for Medical Devices is Essential
Legal Compliance & Market Access
Manufacturing devices without a valid license contravenes the regulations under the Drugs & Cosmetics Act and the Medical Devices Rules, 2017. Holding the manufacturing license for medical devices demonstrates legal readiness and allows you to enter the market confidently.
Quality Assurance & Readiness
The manufacturing license process requires your site, QMS, staff and documentation to meet defined standards. This enhances your credibility with buyers and partners. As one exporter told Diligence Certifications: “once the license came, overseas buyers didn’t question our manufacturing capability; we became trusted.”
Competitive Positioning
Licensed manufacture means you can cite regulatory approval to win bids, negotiate supply contracts, or partner with hospital groups. Without a manufacturing license for medical devices, your business may be sidelined by competitors who hold it.
Risk Management
Delays or re-applications due to missing license impose cost, time and reputational risks. A robust manufacturing licence for medical devices acts as risk mitigation—preventing shutdowns, recalls or contractual defaults.
Who Should Apply for a Manufacturing License for Medical Devices?
Manufacturers of Class A & B Devices
If you produce low to moderate risk devices in India (Class A or B), you must obtain the manufacturing license for medical devices via the State Licensing Authority.
Manufacturers of Class C & D Devices
For moderate to high risk devices (Class C or D), the manufacturing license for medical devices must be granted by the Central Licensing Authority.
Contract Manufacturers or Imported Device Producing Entities
If your site offers contract manufacturing, or you transform import components into finished devices in India, obtaining the manufacturing license for medical devices remains essential. Some businesses miss it, assuming import license alone suffices—but they risk non-compliance.
Expansion or New Site Scenarios
When adding new manufacturing lines, relocating a site, or introducing additional device categories, you must update or apply for the manufacturing license for medical devices. Overlooking this triggers regulatory gaps later.
Step-by-Step: How to Obtain Your Manufacturing License for Medical Devices
Step 1: Site & Quality Audit
Begin by assessing your facility: manufacturing layout, utility control, calibrated equipment, trained staff and QMS implementation per ISO 13485. Identify gaps, correct them, then move to application.
Step 2: Register on the Portal & Fill Application
Create an account on the CDSCO medical pre-licensing portal (e.g., SUGAM). Submit the application for the manufacturing license for medical devices: Form MD-3 for Class A/B, Form-MD-7 for Class C/D.
Step 3: Documentation Preparation
Prepare and upload key documents: Device Master File (DMF), Plant Master File (PMF), QMS certificate (ISO 13485), test-data, risk-management reports, clinical evaluation (if required).
Step 4: Inspection & Evaluation
The licensing authority inspects your manufacturing site (especially for Class B onwards). Inspection covers manufacturing processes, documentation control and record-keeping. Ensure readiness for audit.
Step 5: Grant of License & Post-Approval Compliance
Once documentation and inspection satisfy requirements, the manufacturing license for medical devices is granted (in Form MD-5 or MD-9). You then move into production, maintain records, and prepare for renewal.
Documents & Operational Requirements for Manufacturing License
Key Documentation Check-List
- DMF and PMF: Device design, manufacturing process, facility layout, change-control.
- QMS certificate (ISO 13485:2016) and associated procedures.
- Proof of legal entity, GST, PAN, firm registration.
- Manufacturing site address proof, tenancy or ownership documents.
- Technical staff qualification, calibration records, validation protocols.
- Fee payment proof, cleared inspection report.
Facility & Operational Norms
Your manufacturing site must satisfy Good Manufacturing Practice (GMP) standards, maintain controlled environment (if needed), equipment must be validated, personnel must be trained, and batch-records must be maintained.
Validity, Renewal & Change-Notification
The manufacturing license for medical devices typically remains valid for five years from date of grant, subject to retention-fees and compliance. Renewal or change notification is mandatory if site, device category or process changes.
Common Challenges & Strategic Tips to Avoid Them
Incorrect Device Classification
Incorrectly classifying a device (e.g., treating a Class C device as Class B) delays approval and requires re-submission. Correct classification is foundational.
Incomplete or Poor Documentation
Missing DMF sections, unqualified personnel, missing QMS certification and weak PMF contents result in queries and delays. Preparation and clarity matter.
Poor Inspection Readiness
Inadequate facility preparation, missing validations, untrained staff or lack of traceability prompt negative inspection outcomes. Pre-audit readiness is critical.
Engage Expert Consultancy Early
A regulatory partner like Diligence Certifications can perform gap-audit, guide QMS setup, draft PMF/DMF, manage portal submissions and monitor post-license compliance—making the whole process smoother and faster.
Maintain Continuous Compliance
License grant marks the beginning—not the end. Maintain records, reviews, corrective actions and internal audits to avoid compliance risk and strengthen your manufacturing license for medical devices long-term.
How One Manufacturer Legitimised Production
An SME in Pune manufacturing Class A pulse oximeters had started production based on in-house optimism. They received orders, but major hospital chains required proof of manufacturing license. With a partner consultancy engaged, they reviewed site readiness, prepared documentation, applied on SUGAM, passed inspection and obtained the manufacturing licence for medical devices within ten weeks. Post-licene, the firm scaled rapidly, gained hospital contracts and positioned for export. This real-world example shows the licence is not a regulatory checkbox—it enables growth.
Conclusion
Obtaining your medical device manufacturing licence is a strategic imperative—one that grants you legal manufacturing rights, market access and operational credibility. With careful classification, complete documentation, inspection readiness and possibly specialist consultancy support, you turn the licence journey into a growth enabler rather than a compliance burden.
If you’re ready to scale manufacturing of Class A, B, C or D devices, let Diligence Certifications be your regulatory partner and ensure your manufacturing licence for medical devices becomes a competitive asset.
Frequently Asked Questions
What exactly is a medical device manufacturing license?
A medical device manufacture license is a CDSCO approval that permits organizations to manufacturing and selling medical devices lawfully in India.
Who is the issuing authority for the medical device manufacture license in India?
The Central Drugs Standard Control Organisation (CDSCO) issues medical device manufacturing licenses, along with the State Licensing Authorities based on its device class.
What is the application form for a medical device manufacturing license?
The Manufacturer uses Form MD-3 for Class A & B devices and Form MD-7 for Class C & D devices.
How long does it take to receive a related medical device manufacture license?
Applicant can typically expect the time it takes to acquire a manufacture license to be from 6 to 12 weeks, depending on whether the documentation is complete or inspections are required.
What documents are needed by an applicant to acquire a medical device manufacturing license?
Essential documentation includes the Device Master File (DMF), Plant Master File (PMF), QMS certificate typically ISO 13485, and site related details.
What is the term of a medical device manufacture license?
The license is usually valid for five years, based date of the issued licenses, as long as compliance and renewal license (retention fee) is met.
What is the medical device manufacturing licenses fee?
The fees required for the issuances of medical device licenses vary by class of the device, or as prescribed in the Medical Devices Rules, 2017 and CDSCO guidelines.
Are startups eligible to apply for a license to manufacture medical devices?
Yes, as long as they have an adequate facility, qualified competent staff and documentation they can apply.
What is the penalty for manufacturing without a CDSCO license?
The penalty for manufacture is either a penalty of fine, closure of the manufacturing facility or criminal action as specified in the Drugs & Cosmetics Act.
Why do I need a consultant for the medical device manufacturing license?
An experienced consultant will properly classify devices, assist in the documentation process, and ease the submission process for CDSCO approval.
