The healthcare and medical device sector in India is growing rapidly, driven by innovation, demand for advanced equipment, and the push for local manufacturing. If you’re involved in producing, importing, or distributing medical devices, compliance with regulatory standards isn’t optional — it’s essential. One such important requirement is the MD-42 License.
For manufacturers operating in Haryana, understanding the MD-42 license, its purpose, eligibility, and application process can help you stay compliant and avoid penalties. This article breaks down everything you need to know about the MD-42 License in Haryana, from its meaning and requirements to the step-by-step process for obtaining it.
What Is the MD-42 License?
The MD-42 License is a regulatory authorization issued under the Medical Devices Rules, 2017 by the Central Drugs Standard Control Organization (CDSCO). It allows businesses to manufacture Class C and Class D medical devices in India.
Medical devices in India are categorized into four classes based on risk levels:
Class A – Low risk (e.g., thermometers, stethoscopes)
Class B – Low to moderate risk (e.g., suction equipment, surgical gloves)
Class C – Moderate to high risk (e.g., ventilators, infusion pumps)
Class D – High risk (e.g., implantable devices, heart valves, pacemakers)
The MD-42 license applies to manufacturers producing Class C and Class D devices, which require stricter quality assurance, testing, and documentation.
In simple terms, if your business manufactures complex or high-risk medical devices, you must obtain an MD-42 license to legally operate in Haryana or anywhere in India.
Why Is the MD-42 License Important?
The MD-42 license ensures that medical devices being manufactured meet safety, efficacy, and quality standards as prescribed by Indian regulatory authorities. It’s not just a compliance formality — it’s a legal and ethical responsibility.
Key reasons why the MD-42 license is essential:
Legal Requirement:
Manufacturing without a valid MD-42 license can lead to legal penalties, product seizures, and cancellation of operations.Quality Assurance:
It ensures that medical devices meet the highest standards of safety and performance.Market Access:
Licensed manufacturers gain easier access to domestic and international markets.Credibility:
A CDSCO-issued license enhances your brand’s reputation and assures customers of product quality.Global Acceptance:
As India aligns with international standards, MD-42 licensing strengthens your eligibility for global certifications and export approvals.
Who Needs the MD-42 License in Haryana?
The MD-42 license is mandatory for:
Medical device manufacturers producing Class C or D devices in Haryana.
Companies assembling or packaging Class C and D devices.
Businesses engaged in contract manufacturing for other licensed entities.
If your factory or manufacturing unit is located in Haryana, the application process involves both state-level regulatory bodies and the CDSCO for inspection and approval.
Documents Required for MD-42 License Application
To apply for an MD-42 License in Haryana, manufacturers must submit detailed documentation proving technical competence, facility compliance, and product safety.
Here’s a list of essential documents required:
Application Form (MD-7) duly filled and signed.
Covering Letter stating the purpose and details of the application.
Manufacturing Site Master File – providing an overview of your factory’s infrastructure and operations.
Device Master File – containing product-specific information, manufacturing process, and safety data.
Quality Management System (QMS) Certificate (usually ISO 13485:2016).
Details of Technical Staff – including their qualifications and experience in device manufacturing.
List of Machinery and Equipment used in the manufacturing process.
Layout Plan of the manufacturing site showing areas for production, testing, and storage.
Details of the Authorized Signatory and applicant company.
Fee Payment Proof as per CDSCO guidelines.
Product Details including name, intended use, and device class (C or D).
All documents must be uploaded online and submitted physically during inspection when required.
Step-by-Step Process to Obtain an MD-42 License in Haryana
Here’s how the MD-42 license process generally works:
Step 1: Determine Your Device Classification
Identify whether your medical device falls under Class C or D according to CDSCO’s official classification list.
Step 2: Prepare Documentation
Gather all necessary documents including your QMS certificate, site master file, and device details.
Step 3: Online Application Submission
Visit the CDSCO online portal (SUGAM).
Register your company and fill out the Form MD-7 for manufacturing Class C/D devices.
Upload all supporting documents and pay the required government fees online.
Step 4: Site Inspection
The State Licensing Authority (SLA) in Haryana, in coordination with the CDSCO, will inspect your manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and QMS standards.
Step 5: Review and Approval
If your facility and documentation meet the required standards, the authority will issue the MD-42 License using Form MD-9.
Step 6: License Validity
The MD-42 license remains valid for five years unless it’s suspended or cancelled due to non-compliance.
Government Fees for MD-42 License
The government fee for an MD-42 license depends on the number of devices and manufacturing sites included in your application. Typically, it includes:
Application Fee: ₹50,000 per manufacturing site
Device Fee: ₹1,000 per medical device
However, these charges are subject to change as per CDSCO notifications, so always verify the latest fee structure before applying.
Renewal of MD-42 License
The renewal process for the MD-42 license in Haryana should be initiated before the expiry of the current license.
Renewal Steps:
Submit the renewal application through the SUGAM portal.
Attach updated QMS certificates and compliance records.
Pay the renewal fee as applicable.
The authority may conduct a re-inspection before granting renewal.
It’s advisable to begin the renewal process at least six months before expiry to avoid any operational delays.
Responsibilities of MD-42 License Holders
After obtaining the MD-42 license, the manufacturer must:
Maintain Good Manufacturing Practices (GMP).
Ensure traceability and recall systems for defective devices.
Keep a record of complaints and adverse events.
Report major changes in the device design or process to CDSCO.
Undergo regular audits and inspections.
Compliance is an ongoing responsibility, not a one-time event.
Common Challenges Faced by Applicants
Many applicants face difficulties during the MD-42 licensing process due to:
Incomplete or inconsistent documentation.
Lack of a valid QMS certification.
Improper site layout or facility design.
Delays in inspection scheduling.
Seeking expert assistance can help streamline the process and avoid costly rejections.
How PSR Compliance Can Help
Applying for an MD-42 license involves technical documentation, regulatory understanding, and coordination with authorities — which can be complex for first-time applicants. PSR Compliance offers professional support for obtaining the MD-42 license in Haryana, guiding you through each stage from classification and documentation to inspection readiness and approval.
Their team ensures your application meets every requirement, reducing delays and improving approval chances. With their expertise, you can stay focused on your core business while ensuring full regulatory compliance.
For more details, visit: https://www.psrcompliance.com/blog/md-42-license-in-india
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