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- The MD-5 License grants legal manufacturing rights for Class A and Class B medical devices in India under the Central Drugs Standard Control Organisation (CDSCO) regime.
- Applying for the MD-5 License involves submitting an application via Form MD-3 to the State Licensing Authority (SLA), followed by inspection and approval.
- Key prerequisites include a compliant Quality Management System (QMS) (for example ISO 13485), Device Master File (DMF), Plant Master File (PMF) and site readiness.
- Small- and medium-scale manufacturers of low- to moderate-risk devices (Class A & B) gain competitive advantage by obtaining the MD-5 License swiftly and accurately.
- Without the MD-5 License, manufacturing, sale or distribution of Class A/B medical devices in India involves regulatory risk, delays and lost market opportunity.
Introduction
An early-stage Delhi-based startup developed a Class B digital blood pressure monitor, ready for manufacture. They invested in tooling, set up the factory, hired staff—but when they attempted to launch, their first batch was held up because they had not secured the MD-5 License. The local state regulator flagged non-compliance under the Medical Devices Rules, 2017 and demanded immediate cessation of production until the correct manufacturing licence was in place. The company lost two months of production and valuable prospective orders. Once they engaged an expert partner, obtained audit readiness, submitted Form MD-3 and secured the MD-5 licence, their production restarted and they met their client commitments.
This scenario underscores that the MD-5 License is not a peripheral formality—it is the gateway to manufacturing legally, safely and competitively in India’s medical-device sector. For manufacturers of Class A and Class B devices, the MD-5 licence represents more than paperwork: it is your foundation for product credibility, market access and compliance assurance.
In the following sections we will cover what the MD-5 licence is, who needs it, how to apply, practical requirements, common pitfalls, and how your business—especially working with a trusted consultancy—can accelerate the process and mitigate risks. Real-world insights, analogies and regulatory references are embedded to give you operational clarity.
What the MD-5 License Actually Is (H2)
The MD-5 License refers to the manufacturing licence issued under Form MD-5 by the State Licensing Authority (SLA) for manufacturing Class A & Class B medical devices in India.
Under the Medical Devices Rules, 2017, the process is: apply by Form MD-3, then after review and inspection the licence is granted under Form MD-5 for Class A/B. The MD-5 License essentially equips the manufacturer with legal permission to “manufacture for sale or for distribution” Class A and B medical devices from the approved site.
It is key to note: devices of higher risk (Class C and D) require a separate route (Form MD-7 application leading to Form MD-9 licence).
In practical terms, if you are planning to manufacture a Class A or B medical device (for example, a non-invasive thermometer or a low-risk IVD kit), you must obtain the MD-5 licence before you commercialise. Without it, you expose your business to regulatory enforcement, invalidation of product batches, and lost reputation.
Why the MD-5 License Matters for Manufacturers
Key reasons the MD-5 licence deserves priority in your regulatory roadmap.
Legal Compliance and Market Entry
Operating without the MD-5 licence means manufacturing is technically unauthorised. Under the Medical Devices Rules, 2017, the licensing norms apply to devices, and the central regulator requires licensing from the SLA for Class A/B devices.Having the MD-5 licence shows your credentials as a compliant manufacturer—buyers, hospitals and distributors take notice.
Quality & Audit Readiness
The MD-5 process demands audit of your QMS (Quality Management System) and a review of plant and device master files. These are markers of manufacturing fitness, signalling to partners that you meet recognised standards such as ISO 13485.This reduces risk of defects, recalls or regulatory action.
Competitive Advantage and Credibility
In a crowded medical-device market, manufacturing licence helps differentiate your company. You demonstrate regulatory readiness, which supports contracts, export opportunities, and investor confidence. In one case, a midsize firm in Hyderabad won an exclusive distribution tie-up only after showing an MD-5 License for its manufacturing site.
Risk Mitigation
Delays, wrong licence class, missing documentation—all cost money. Having the right licence (MD-5) and doing it properly saves you from re-applications, audit non-conformities or even shutdowns. As regulatory scrutiny tightens in India, compliance becomes not optional.
Who Needs to Apply for the MD-5 License?
Manufacturers of Class A & B Devices
If your business involves manufacturing Class A or Class B medical devices (including IVDs) in India, you require the MD-5 License. The application is via Form MD-3 and the licence is granted as Form MD-5.
Existing Manufacturers Expanding Sites or Product-Range
If you already have a manufacturing unit but intend to add new devices (Class A/B) or launch a new site, you must update your licence or apply for fresh MD-5. Some firms overlook this update and face compliance gaps.
Importers or Contract Manufacturers with Indian Manufacturing
If you are an import-linked entity setting up local manufacturing for Class A or B devices, you still need the MD-5 licence for the manufacturing site.
Clarifying Classification: When It Doesn’t Apply
If your device falls under Class C or D, the MD-5 route is not applicable: instead use Form MD-7 → Form MD-9. If your device is non-sterile non-measuring Class A device, some exemptions may apply—but it is safer to treat MD-5 as baseline.
How to Apply for the MD-5 License
Step 1: Pre-assessment & Gap-Audit
Begin by assessing your site, QMS, device classification, site master file and device master file. Identify gaps relative to Schedule V of the Medical Devices Rules, 2017 – for example, manufacturing facility layout, equipment calibration, personnel qualifications. A consultant can prepare a gap-audit to ensure you’re inspection-ready.
Step 2: Register on Online Portal & Fill Form MD-3
For Class A & B manufacturers, the online portal (e.g., SUGAM or SLA portal) will require registration. You upload firm details, site address, device categories and pay fees. Form MD-3 is the application for grant of manufacturing licence.
Step 3: Document Preparation & Upload
You’ll need to gather and upload documents such as:
- Plant Master File (PMF) outlining facility layout, equipment, processes.
- Device Master File (DMF) detailing each device’s design, materials, risk management.
- Quality Management System certificate (preferably ISO 13485).
- Evidence of manufacturing batches (for IVDs), environmental clearances, staffing details, instrument calibration.
- Fee payment proof and signatures.
Step 4: Audit / Inspection (If Applicable)
For Class B devices, an audit by a Notified Body may be mandated prior to licence. The manufacturing site may also be inspected by the State Licensing Authority.
Ensure your facility is operational, documented, staff trained and records maintained, so inspection does not expose non-conformities.
Step 5: Licence Issuance as Form MD-5
Once documentation is accepted and inspection cleared (if applicable), the State Licensing Authority issues the licence in Form MD-5. This grants you permission to manufacture Class A & B devices from the specified site.
You should receive the licence within timelines (which vary by state) and it remains valid for a defined period (typically five years) subject to retention fees.
Step 6: Post-licence Obligations
After obtaining the MD-5 licence, maintain compliance: document batch records, keep the QMS system updated, notify any changes in manufacturing site/process to the authority, allow inspections and keep safety vigilance systems operational. Non-compliance may lead to licence suspension or revocation.
Key Document & Operational Requirements for the MD-5 License
Focusing on what the regulator expects will increase your chances of success.
Mandatory Documents (at least)
- Completed Form MD-3 application with signatures
- Company incorporation certificate, PAN, GST registration
- Plant Master File – facility layout, equipment, utilities
- Device Master File – device specifications, performance data
- Quality Management System certificate (ISO 13485)
- Evidence of three consecutive manufacturing batches (for IVDs) in some cases.
- Environmental/occupational clearances (if required)
- Fee payment proof and application receipt.
- Undertaking that the site will comply with Fifth Schedule standards (under MDR-2017).
Operational Standards
- Facility must be suitable for manufacturing Class A/B device types (e.g., non-sterile vs sterile)
- Personnel must be technically qualified and aware of implementation of QMS
- Records maintained for production, calibration, validation, traceability and post-market vigilance
- For devices needing audit, the Notified Body report must be submitted.
- If manufacturing sterile devices, additional standards apply.
Validity, Renewal & Change Management
- The MD-5 licence is valid until its expiry (usually 5 years) and subject to payment of retention fee.
- Any change in site address, device category or process may need notification or fresh application.
- Periodic internal audit, management review, corrective & preventive actions (CAPA) must be in place as per QMS.
Common Challenges and Strategic Tips
Understanding typical mistakes will allow you to avoid them and save time and resources.
Wrong Device Class or Activity
One manufacturer applied for MD-5 licence for a device but later discovered their device was Class C—not Class A/B—so the application had to switch path (to MD-9) and got delayed. Always confirm risk class before initiating.
Incomplete or Poorly Prepared DMF/PMF
Quality of documentation is a major factor—poorly structured Plant Master File, missing equipment validation or unclear personnel records cause queries. Ensure that documents are professionally collated, not just assembled.
Ignoring QMS Requirements
Many firms ignore the fact that even for Class A devices they must maintain records, quality system and may be subject to audits. A robust QMS (preferably ISO 13485) streamlines the process.
Underestimating Inspection Readiness
While some Class A devices may not require audit before licence, many states still inspect manufacturing units. If facility is not ready—layout, staff training, process controls—the inspection triggers non-conformities and delays.
Engage Expertise Early
It is far more cost-effective to engage a regulatory consultant or agent in the early stage of manufacturing set-up rather than after delays begin. A proactive regulatory partner will perform gap audit, guide QMS implementation, verify document set-up and monitor timeline for MD-5 licence issuance.
How One Manufacturer Acquired the MD-5 License in 10 Weeks
A North-Indian SME manufacturing syringes (Class B device) engaged with Diligence Certifications when their in-house team estimated a 6-month timeline. The regulatory consultancy conducted a gap audit, prepared the Plant Master File and Device Master File, trained staff for QMS and coordinated with the Notified Body for audit readiness. They submitted Form MD-3 within 4 weeks, passed audit in week 6, and received the MD-5 Licence in week 10 from SLA. The result: The company began commercial manufacturing on schedule and avoided contractual setbacks.
This example illustrates how structured planning, expert oversight and efficient coordination reduce timeline, risk and cost when obtaining the MD-5 licence.
Working with a Regulatory Consultancy for the MD-5 License
What to Expect from a Good Partner
- Deep understanding of MDR-2017, device classification, annexes and schedules.
- Documentation drafting: DMF, PMF, QMS procedures, forms.
- Portal submission support: Form MD-3 submission, fee payment, upload tracking.
- Notified Body coordination for Class B audits.
- Pre-inspection readiness review and mock audits.
- Post-grant support: retention, change notifications, licence renewal.
How to Select a Partner
Ask for case-studies of MD-5 licence grants, references from other manufacturers, clarity about timelines and transparent fee structure. Ensure they monitor updates from the CDSCO and state regulators.
Collaborative Engagement Process
- Initial consultation and gap assessment.
- Project plan: milestone definitions (documentation submission, audit, licence grant).
- Weekly status updates with submission tracker.
- Inspection pack, training and mock audit.
- After-licence support for change-control and renewal management.
Conclusion
Securing the MD-5 Licence is a foundational step for any manufacturer of Class A/B medical devices in India. It is not just a piece of paper—it signifies your readiness to manufacture safely, meet regulatory standards, and compete in the market. With the right planning, documentation, and expert support you can transform the licence process from a regulatory hurdle into strategic advantage.
If you are preparing to launch or expand your manufacturing site for Class A or B devices, now is the time to engage support—ensure your QMS is audit-ready, your master files complete, your plant prepared and your application (Form MD-3) submitted with precision. With that, the MD-5 Licence becomes the cornerstone of your regulatory compliance and business growth.
Ready to secure your MD-5 License and scale manufacturing with confidence? Contact the team at Diligence Certifications today—your partner in regulatory excellence for India’s medical-device industry.
