Manufacturing License for Medical Devices in India
Manufacturer License for Medical Devices
Start off strong in India’s booming medical device scene by getting the basics of rules right. If you’re building something like a patient tracker or maybe an implant for surgery, a CDSCO production license isn’t only required by law – it’s what lets you actually sell there. MD05, meant for Class A/B devices, along with MD09 for Class C/D Devices, show that products meet India’s strict rules for safety, function, and clear documentation. This walkthrough cuts through the confusion around permits, boosts your ability to follow regulations, and supports everyone involved – startups, makers, or big international firms – to step into India’s health sector without second-guessing.
Important Terminologies
- MD03: It is an application form to get a license to manufacture and sale of medical devices of class A & B except Class A (Non Sterile – Non Measuring).
- MD05: It is a license that SLA grants to manufacture and sale of medical devices of class A & B except Class A (Non Sterile – Non Measuring).
- MD07: It is an application form to get a license to manufacture and sale of medical devices of class C & D.
- MD09: It is a license that CDSCO grants to manufacture and sale of medical devices of class C & D.
Licensing Authority Involved
- MD05 for Class A/B devices: State Licensing Authority (SLA)
- MD09 for Class C/D devices: Central Licensing Authority (CDSCO HQ)
- Both work under the Ministry of Health & Family Welfare; however, SLA deals with low or moderate-risk gear (Class A/B), whereas CDSCO takes charge of high-risk ones (Class C/D).
Which Particular License Is Required
- MD05: If you’re planning to make Class device- low risk – or Class B stuff, which carries a bit more risk.
- MD09’s made for makers of Class C device – that’s high risk – along with those building Class D stuff, which is seen as critical risk.
Process for Manufacturing License For Medical Device
1️⃣ Classification Assessment
Sort your gadget following MDR 2017 rules – pick Class A, B, C, or D based on its type.
2️⃣ Online Portal Registration
Sign up at CDSCO-SUGAM; get your login details.
3️⃣ Application Submission
With MD05: Complete Form MD-3 (for a fresh license) through the State website.
With MD09: Complete Form MD-7 using the CDSCO website.
4️⃣ Upload Mandatory Documents
Detailed beneath.
5️⃣ Technical Scrutiny & Query Resolution
SLA/CLA checks the papers you send – clears up confusion, in case something’s unclear.
6️⃣ Site Audit/Inspection
A check of the site by an approved group to meet required rules.
7️⃣ Product Compliance Scrutiny
A close look at the device master file, focusing on one particular product.
8️⃣ License Grant
MD05 or MD09 shows up when rules are followed – lets you make or sell legally.
List Of Documents Required For Manufacturing License
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Covering Letter to SLA/CLA Formal submission letter addressed to the State or Central Licensing Authority summarizing the application.
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Constitution Documents Legal documents establishing the applicant’s business identity and ownership structure.
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Plant/Site Master File Comprehensive overview of the manufacturing facility, infrastructure, and operations.
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Device Master File (Appendix II, MDR 2017) Technical dossier containing detailed product information, manufacturing process, and safety data.
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ISO 13485/ICMED Certificate Proof of compliance with international quality management standards for medical devices.
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Info on Tech Staff Details of key technical personnel including resumes, qualifications, and professional experience.
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Site Layout Plan Diagram showing the layout of the manufacturing premises, equipment, and workflow.
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Sale/Rent Deed of Premises Ownership or rental agreement verifying legal possession of the manufacturing site.
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QMS and SOP Documentation Quality management system records and standard operating procedures for consistent production.
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Product Labels & Batch Certificates Approved labeling samples with test certificates of three consecutive batches ensuring quality consistency.
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Fees Challan Receipt Proof of payment for government license or application processing fees.
Validity And Renewal
- Validity: MD05 and also MD09 come with indefinite duration, as long as a state-maintained renewal charge is covered every 5 Years.
- Renewal: Skip the usual renewal – keep your license active by paying the retention fee before the five-year window ends.
It refers to the process of keeping a medical device license or registration valid by regularly renewing it. This ensures that the manufacturer or importer complies with regulations and can legally continue their activities.
– We have to pay total fees same as for fresh MD15 License
Falling behind on payments or breaking rules could mean your status gets paused or dropped; to get it back, they might make you go through another review or check-up.
Manufacturing License Government Fees in India
|
S.No.
|
Applicant
|
Class of Device
|
Govt fees for plant
|
Govt fees per product
|
|---|---|---|---|---|
|
1
|
Manufacturer
|
A
|
Rs 5,000
|
Rs 500
|
|
2
|
Manufacturer
|
B
|
Rs 5,000
|
Rs 500
|
|
3
|
Manufacturer
|
C
|
Rs 50,000
|
Rs 1000
|
|
4
|
Manufacturer
|
D
|
Rs 50,000
|
Rs 1000
|
Frequently Asked Question
A fresh application with additional device details and fees must be submitted for each new device.
No, a separate license is required for each manufacturing location.
Non-compliance can lead to rejection, suspension, or cancellation of the license and halt manufacturing operations.
Yes, but all contract sites must be listed, and each must comply with QMS and regulatory requirements. Imported components must meet Indian standards and be traceable.
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