CDSCO MD9 License (Form MD7) – Complete Guide (2026)

Who needs the MD-9 License?

The MD-9 license is mandatory for any individual, company, or organization that wants to manufacture Class C or Class D medical devices in India for the purpose of sale, distribution, or commercial use. The following types of entities must obtain this license:

• Indian companies (private limited, public limited, LLP, partnership firms, sole proprietorships, or MSMEs) setting up a new manufacturing unit for Class C or Class D devices.
• Existing manufacturers of Class A or B devices who are expanding their product range to include Class C or D devices a separate MD-9 license is required even if they already hold an MD-5 license.
• Contract manufacturers producing Class C or D devices on behalf of another brand or company the manufacturing facility itself must hold the license, regardless of who owns the product brand.
• Companies upgrading a previously registered Class C or D device (notified under the older registration framework) to the new licensing framework under GSR 102(E) dated 11.02.2020.
• Any business that has been manufacturing Class C or D devices without a license and needs to regularize their operations.

The MD-9 license is not required by importers (they need a separate import license under Form MD-15), traders, or distributors who do not manufacture devices themselves.

Devices that require MD-9 License

Any medical device that falls under Class C (moderate to high risk) or Class D (high risk) as classified by CDSCO under the Medical Devices Rules, 2017 requires an MD-9 license for manufacturing. Below are the major categories and examples:

Class C - Devices (Moderate to High Risk)

• Bone plates, bone screws, and orthopaedic implants (non-active)
• Powered wheelchairs and motorized rehabilitation equipment
• Infusion pumps and syringe drivers
• Cardiac stents (non-drug eluting)
• X-ray machines and diagnostic imaging systems
• MRI machines and CT scanners
• Ventilators and anaesthesia machines
• Haemodialysis machines
• Intraocular lenses
• High-risk in-vitro diagnostic (IVD) devices such as blood glucose systems and HIV test kits

Class D - Devices (High Risk)

• Heart valves (mechanical and biological)
• Implantable cardiac pacemakers
• Drug-eluting coronary stents
• Implantable defibrillators
• Cochlear implants
• Total artificial hearts
• Spinal cord stimulators
• Implantable neurostimulators
• Ventricular assist devices
• Any life-sustaining or implantable active device not listed under a lower class
• If you are unsure whether your device is Class C or D, refer to the CDSCO medical device classification list published on the official CDSCO website, or seek a formal written classification opinion before applying.

Eligibility Criteria for MD-9 License

To apply for the CDSCO MD-9 manufacturing license for Class C and Class D medical devices, your company must fulfil the following eligibility conditions before submitting the application. Meeting these criteria is mandatory CDSCO will verify each one during document review and factory inspection.

1. Legal Business Entity

The applicant must be a legally registered business entity in India. This includes private limited companies, public limited companies, partnership firms, LLPs, sole proprietorships, and MSMEs. You must have valid GST registration, a PAN card, and a Certificate of Incorporation or equivalent legal proof.

2. Ownership or Legal Right Over Manufacturing Premises

You must own or hold a valid lease/rental agreement for the manufacturing facility. The premises must be a dedicated, permanent location; a residential address or shared commercial office does not qualify as a manufacturing site.

3. Certified Quality Management System (QMS)

Your manufacturing facility must be certified under ISO 13485 (International Standard for Medical Device Quality Management Systems) or its Indian equivalent, ICMED 13485. This certification must be valid and issued by an accredited certification body. Operating a QMS that is not yet certified at the time of application will result in rejection.

4. Qualified Manufacturing Head

The person responsible for overseeing manufacturing must hold one of the following:
A degree in Engineering, Pharmacy, or Science from a recognized university, with a minimum of 2 years of hands-on experience in medical device manufacturing, OR
A diploma in Engineering or Pharmacy from a recognized institution, with a minimum of 4 years of experience in medical device manufacturing.

5. Qualified Testing / Quality Control Staff

The person responsible for product testing and quality control must hold one of the following :
A degree in Engineering, Pharmacy, or Science, with a minimum of 2 years of experience in medical device testing, OR
A diploma in Engineering, Pharmacy, or Science, with a minimum of 2 years of experience in medical device testing.

6. GMP-Compliant Manufacturing Facility

The factory must be designed and operated as per Good Manufacturing Practice (GMP) guidelines laid down in the Fifth Schedule of the Medical Devices Rules, 2017. This covers room segregation, controlled environments, defined material flow, and documented processes.

7. Environmental Clearances

Before applying, you must obtain both of the following :
Fire Safety NOC from the local fire department
Pollution Control NOC from the State Pollution Control Board
These NOCs confirm your facility is safe to operate and does not pose environmental or safety risks.

8. Complete Technical Documentation Ready

You must be prepared and ready to submit at the time of application a Device Master File (DMF) and a Plant Master File (PMF) for every product you intend to manufacture. These cannot be prepared after submission.

9. Formal Declaration of Compliance

The applicant must sign and submit a formal declaration of compliance with the Medical Devices Rules, 2017, confirming that all manufacturing, testing, labelling, and distribution activities will follow these rules throughout the license period.

CDSCO Factory Inspection Checklist

The factory inspection (also called a GMP audit) is conducted by CDSCO-appointed inspectors before the MD-9 license is granted. The inspector will physically verify the following. Use this checklist to make sure your facility is fully ready before the inspection date.

A. Documentation Review (Conducted On-Site)

• Plant Master File present, updated, and matching the actual facility
• Device Master Files complete for all products listed in the application
• Standard Operating Procedures (SOPs) written, approved, and actively followed by staff
• Batch Manufacturing Records available for any test batches produced
• Quality Manual present, version-controlled, and covering all manufacturing activities
• ISO 13485 / ICMED 13485 Certificate valid and displayed
• Staff qualification files available for all key personnel (manufacturing head, QC head, line staff)
• Equipment calibration records all instruments calibrated with valid stickers and due dates
• Validation records for processes like sterilization, cleaning, and critical equipment
• CAPA records documented corrective and preventive actions from internal audits
• Internal audit reports at least one complete internal audit on record
• Risk Management File (ISO 14971) present for each product

B. Premises and Infrastructure

• Layout plan matches the physical layout every room and zone correctly labelled
• Defined and separated zones raw material storage, manufacturing area, finished goods storage, and reject/quarantine area are distinct
• Clean corridor and dirty corridor separation no cross-contamination pathway between clean and unclean zones
• Adequate lighting in all working areas minimum lux levels as per GMP norms
• Flooring smooth, non-porous, washable, and free from cracks
• Walls and ceilings painted or coated with easy-to-clean, non-shedding material
• Doors and windows properly sealed, no gaps, pest-proof
• Changing room / gowning area present and functional before entry to the manufacturing area
• Washbasins available near entry to cleanrooms and manufacturing areas, with soap and sanitizer
• Adequate ventilation HVAC or controlled airflow systems operational
• Temperature and humidity monitoring sensors installed and daily logs maintained

C. Cleanrooms (Where Applicable)

• Cleanroom classification signage class of environment displayed at entry
• Air filtration systems (HEPA filters) installed and operational
• Differential pressure maintained between cleanroom and adjacent areas with pressure gauges visible
• Particle count records logged and within acceptable limits
• Personnel trained on gowning procedures and gowning log maintained
• Cleanroom cleaning and disinfection schedule posted and followed

D. Equipment and Machinery

• All machines and equipment listed in the PMF are physically present and installed
• Equipment is in working condition not damaged or under repair at the time of inspection
• Equipment identification numbers / tags each machine tagged with its ID, calibration date, and next due date
• Dedicated cleaning tools for each zone no cross-zone use
• Preventive maintenance schedule documented and followed

E. Quality Control Laboratory

• Separate QC lab space not combined with the manufacturing area
• Lab instruments and testing equipment calibrated, labelled, and functional
• Reference standards and reagents properly labelled with receipt date and expiry date
• Test method validation records available for all tests used for product release
• In-process and final product testing records maintained and accessible
• Out-of-specification (OOS) procedure documented and understood by lab staff

F. Storage Areas

• Raw material and component storage area separate from manufacturing, with labelled bins
• Quarantine area physically separate for incoming materials pending release
• Finished goods storage appropriate temperature and humidity conditions maintained
• Rejected material area clearly marked, segregated, and locked
• Flammable materials stored separately in a fireproof cabinet or designated room

G. Personnel Hygiene and Conduct

• All staff present during inspection are wearing appropriate protective gear (gloves, gowns, masks, shoe covers) as applicable
• No eating, drinking, or mobile phone use inside the manufacturing area
• All staff can explain their role and the SOP they follow inspectors may ask random workers to describe their procedure
• No unauthorized personnel in restricted areas during inspection

H. Waste and Safety

• Biomedical waste disposal system documented and compliant with Biomedical Waste Rules
• Chemical waste disposal as per Hazardous Waste Rules
• Fire extinguishers present, charged, and within expiry date
• Emergency exits clearly marked and unobstructed
• First aid box stocked and accessible

Eligibility Criteria for MD-9 License

To apply for the CDSCO MD-9 manufacturing license for Class C and Class D medical devices, your company must fulfil the following eligibility conditions before submitting the application. Meeting these criteria is mandatory CDSCO will verify each one during document review and factory inspection.

1. Legal Business Entity

The applicant must be a legally registered business entity in India. This includes private limited companies, public limited companies, partnership firms, LLPs, sole proprietorships, and MSMEs. You must have valid GST registration, a PAN card, and a Certificate of Incorporation or equivalent legal proof.

2. Ownership or Legal Right Over Manufacturing Premises

You must own or hold a valid lease/rental agreement for the manufacturing facility. The premises must be a dedicated, permanent location; a residential address or shared commercial office does not qualify as a manufacturing site.

3. Certified Quality Management System (QMS)

Your manufacturing facility must be certified under ISO 13485 (International Standard for Medical Device Quality Management Systems) or its Indian equivalent, ICMED 13485. This certification must be valid and issued by an accredited certification body. Operating a QMS that is not yet certified at the time of application will result in rejection.

4. Qualified Manufacturing Head

• A degree in Engineering, Pharmacy, or Science from a recognized university, with a minimum of 2 years of hands-on experience in medical device manufacturing, OR
• A diploma in Engineering or Pharmacy from a recognized institution, with a minimum of 4 years of experience in medical device manufacturing.

5. Qualified Testing / Quality Control Staff

• A degree in Engineering, Pharmacy, or Science, with a minimum of 2 years of experience in medical device testing, OR
• A diploma in Engineering, Pharmacy, or Science, with a minimum of 2 years of experience in medical device testing.

6. GMP-Compliant Manufacturing Facility

The factory must be designed and operated as per Good Manufacturing Practice (GMP) guidelines laid down in the Fifth Schedule of the Medical Devices Rules, 2017. This covers room segregation, controlled environments, defined material flow, and documented processes.

7. Environmental Clearances

• Fire Safety NOC from the local fire department
• Pollution Control NOC from the State Pollution Control Board

These NOCs confirm your facility is safe to operate and does not pose environmental or safety risks.

8. Complete Technical Documentation Ready

You must be prepared and ready to submit at the time of application a Device Master File (DMF) and a Plant Master File (PMF) for every product you intend to manufacture. These cannot be prepared after submission.

9. Formal Declaration of Compliance

The applicant must sign and submit a formal declaration of compliance with the Medical Devices Rules, 2017, confirming that all manufacturing, testing, labelling, and distribution activities will follow these rules throughout the license period.

Complete Documents Checklist

This is a complete checklist of all documents required for the MD-9 license application. Missing even one document can delay your application by months.

Business & Legal Documents

• Duly filled Form MD-7
• GST Registration Certificate
• Certificate of Incorporation / Partnership Deed / Proprietorship Proof
• PAN Card of the company or firm
• Details of Directors / Partners / Proprietor
• Trademark Certificate (if applicable)
• Cover letter stating manufacturing intent and scope

Premises & Facility Documents

• Ownership proof or registered rent/lease deed of the manufacturing premises
• Full layout plan with room dimensions and sections (to scale)
• Site Master File (SMF)
• Photos of facility (interior and exterior)
• Details of all machines and equipment installed
• Fire NOC from local fire department
• Pollution NOC from State Pollution Control Board

Device-Specific Technical Documents

• Device Master File (DMF) for each device
• Plant Master File (PMF)
• List of all products to be manufactured
• Product specifications and intended use statements
• Labels, Instructions for Use (IFU), and packaging details
• Performance testing and validation reports
• Clinical evaluation data (where applicable)
• Risk Management File (as per ISO 14971)

Quality & Compliance Documents

• ISO 13485 or ICMED 13485 Certificate (valid)
• Quality Manual and Standard Operating Procedures (SOPs)
• GMP compliance records
• Equipment calibration and process validation records
• Internal audit reports and CAPA records
• Quality Management System certificate for the production site

Personnel Documents

• Educational qualification certificates of all technical staff
• Experience certificates of key personnel
• Appointment letters of manufacturing head and quality head
• Declaration by responsible technical person
• Organogram of the company (reporting structure)

Step-by-Step Application Process

Here is the complete registration process for the CDSCO MD-9 license, broken down into clear steps.

Step 1: Confirm Your Device Classification

Before anything else, confirm that your device is Class C or Class D as per the CDSCO classification list. Getting this wrong means applying for the wrong license entirely.

Step 2: Prepare All Required Documents

Collect and prepare all documents from the checklist in Section 5. Pay special attention to the Device Master File and Plant Master File. Your quality management system must already be operational and certified.

Step 3: Register on the CDSCO SUGAM Portal

Create an account at the CDSCO SUGAM online portal (cdscomdonline.gov.in). This is the official government platform where all CDSCO applications are submitted.

Step 4: Fill and Submit Form MD-7 Online

Log into the SUGAM portal and fill out Form MD-7 completely. Provide the device classification, brand name, intended use, and a detailed product description.

Step 5: Upload All Supporting Documents

Upload every document in the checklist. Files must be in the correct format (usually PDF) and clearly labelled. Incomplete uploads are the single biggest cause of application delays.

Step 6: Pay the Government Fees

Pay the required application fees online. Keep the payment confirmation receipt. The fee is non-refundable.

Step 7: Receive Your Application Number

Once all documents are submitted and fees are paid, the portal generates an application number. Save this number it is your tracking reference for all future CDSCO communication.

Step 8: CDSCO Reviews Your Application

CDSCO officials examine your application and all documents. If anything is missing or unclear, they will send official queries. Respond through the SUGAM portal promptly.

Step 9: Factory Inspection / GMP Audit by CDSCO

CDSCO will assign inspectors to visit your manufacturing facility. They will check your factory, equipment, quality systems, staff, and documentation. Corrective actions for any findings must be implemented and evidenced.

Step 10: Final Review and License Grant

After all queries are resolved and the audit is satisfactory, CDSCO does a final review and issues the MD-9 license through the SUGAM portal. You are now legally authorized to manufacture and sell your Class C or D devices.

Benefits of obtaining the MD-9 License

Legal authorization to manufacture and sell

The MD-9 license is the only document that makes your manufacturing operations fully legal under Indian law. Without it, every unit you produce is an unauthorized product.

Access to the entire Indian market

Licensed manufacturers can supply directly to hospitals, government health programmes, distributors, and retail medical channels across all states without restriction.

Eligibility for government tenders

Central and state government procurement (including PMBJP, CGHS, ESIC, and defence hospitals) requires valid CDSCO manufacturing licenses. Without an MD-9, you are ineligible to bid.

Stronger brand trust

Healthcare professionals, hospital procurement teams, and distributors actively verify CDSCO license status before placing orders. A valid MD-9 license signals that your product and facility meet national standards.

Foundation for export

Many international buyers and regulatory bodies (including WHO prequalification and foreign distributors) require proof of a valid home-country manufacturing license. Your MD-9 serves as that proof for Indian-origin devices.

Protection from regulatory action

A licensed manufacturer is protected from product seizure, factory shutdown orders, and criminal prosecution that unlicensed manufacturers face.

Ability to scale and add products

Once the MD-9 is in place, adding new Class C or D products to your license is a simpler process than the original application. Growth is structured and documented.

Long-term validity with no expiry pressure

Unlike many licenses that expire every few years, the MD-9 has perpetual validity. You simply pay a retention fee every 5 years and continue operations.

MD-5 vs MD-9: What is the Difference?

Common Mistakes in MD-9 License Applications

These are the most frequently observed errors that delay approvals, trigger CDSCO queries, or result in outright rejection. Avoiding even one of these can save you months of processing time.

Incomplete or Poorly Prepared Device Master File (DMF)

The DMF is the single most common reason for delays. Many applicants submit a DMF that is missing sections, has vague product descriptions, or lacks validation data. Every section from materials list to clinical evaluation to risk analysis must be complete, specific, and supported with evidence.

Plant Master File Does Not Match the Actual Facility

The PMF submitted in the application must exactly describe the factory as it exists on the ground. Inspectors physically verify every detail. Discrepancies between what is written in the PMF and what they see during the audit immediately trigger queries and require a resubmission.

ISO 13485 Certificate Not Valid at Time of Submission

Submitting an application with an expired, provisional, or pending QMS certificate is a disqualifying error. The ISO 13485 or ICMED 13485 certificate must be valid, current, and issued by an accredited body before you submit.

Staff Qualification Documents Missing or Incorrect

Many applicants attach educational certificates but forget to include experience certificates. CDSCO needs both the degree and proof of relevant work experience. Appointment letters alone are not sufficient. A gap between experience claimed and experience documented leads to repeated queries.

Wrong Device Classification Used in the Application

Filing Form MD-7 for a device that actually falls under Class A or B, or vice versa, causes the entire application to be invalidated. Always confirm your device's classification officially before applying. Use the CDSCO website's medical device classification list or seek formal written confirmation.

Factory Not Ready When Inspection Happens

Some manufacturers apply first and plan to fix the factory later. This is a serious mistake. CDSCO schedules the inspection after reviewing documents, and if the factory is not ready, cleanrooms not operational, equipment not installed, SOPs not in practice the inspection fails and the application must restart.

Slow Response to CDSCO Queries

Once a query is raised by CDSCO, you are expected to respond through the SUGAM portal promptly. Many applications stall for months simply because the applicant was slow to upload responses. CDSCO queues move fast when documentation is complete; delays in your reply push you to the back of the queue.

Fire and Pollution NOCs Not Obtained Before Application

Many applicants plan to get these NOCs in parallel while their application is processed. This causes last-minute problems when CDSCO's inspection team asks to verify them on-site. Both NOCs must be in hand before you submit the application.

Mismatch Between Product Label and Product Specifications in DMF

The label including the product name, intended use, warnings, and Instructions for Use (IFU) must be consistent with what is written in the Device Master File. Any mismatch, even in terminology or wording, is flagged as a discrepancy.

Using a Shared or Rented Factory Address Without a Valid Lease Deed

If your manufacturing premises are rented, the lease deed must be registered, current, and confirm the space is for manufacturing use. Month-to-month informal rent agreements and verbal arrangements are not accepted.

Not Disclosing All Products in the Application

Some applicants list only a few products at the time of applying, planning to add more later. While additions are possible, each addition requires a separate application and fee. Listing all intended products at the start avoids repeated applications.

Submitting Hard Copies Instead of Using the Online Portal

The entire MD-9 application process is conducted through the CDSCO SUGAM portal. Sending physical documents to CDSCO offices is not the correct process and will not be processed.