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CDSCO Medical Device Registration
Introduction
CDSCO Form MD-7 is the application a manufacturer files with the Central Licensing Authority to get a manufacturing license for Class C (moderate-to-high risk) or Class D (highest risk) medical devices at their own facility. Once the site is inspected and the documentation is verified, the license is granted in Form MD-9.
The Central Licensing Authority typically inspects the manufacturing site within 60 days of application, and decides on the grant within 45 days of receiving the inspection report. Once granted, the MD-9 license stays valid indefinitely, subject to a retention fee paid every five years.
What Is CDSCO Form MD-7?
Form MD-7 is the application form under the Medical Devices Rules, 2017 for a manufacturer seeking a license to manufacture Class C or Class D medical devices for sale or distribution, at their own manufacturing premises. Because Class C and D devices carry moderate to high risk — think ventilators, orthopaedic implants, or heart valves — the application is reviewed centrally by the Central Licensing Authority (CLA) through CDSCO, rather than by a state authority.
Once CDSCO has scrutinised the application, conducted a site inspection, and confirmed compliance with the Quality Management System requirements under the Fifth Schedule, the manufacturing license is granted in Form MD-9. From that point, the manufacturer is legally authorised to manufacture, sell, and distribute that Class C or D device across India.
Why an MD-7/MD-9 License Matters
Mandatory legal requirement — manufacturing, assembling, or relabeling a Class C or D device for commercial sale in India without a valid MD-9 license is not permitted.
Covers your own manufacturing site fully, with no dependency on a third-party facility's compliance status.
Signals regulatory maturity to hospitals, distributors, and export markets that expect CDSCO-licensed manufacturing for higher-risk devices.
Once granted, the license has no fixed expiry — a real advantage over licensing regimes that require full reapplication every few years.
Supports scaling into new Class C/D product lines under the same manufacturing site once the underlying QMS infrastructure is in place.
Who Needs to Apply Using Form MD-7?
Domestic manufacturers who own or fully control a manufacturing facility and want to produce Class C or Class D medical devices there.
Companies expanding an existing Class A/B manufacturing operation into higher-risk Class C or D product lines.
Foreign or Indian medical device companies setting up a dedicated manufacturing plant in India for moderate-to-high-risk devices.
In-vitro diagnostic (IVD) manufacturers whose test kits fall under the Class C or D risk categories.
If you don't own the manufacturing premises and instead plan to use another company's already-licensed facility, you would apply using Form MD-8 for a loan license rather than Form MD-7.
Site and Documentation Prerequisites
The manufacturing site must comply with the Quality Management System requirements under the Fifth Schedule (ISO 13485 or ICMED 13485-aligned systems are commonly used to demonstrate this).
Qualified technical staff — including a manufacturing chemist and analytical chemist, or equivalent technical personnel — must be appointed to supervise production and testing.
Every device intended for manufacture must have a complete Device Master File, including design, labelling, risk management, and (where applicable) clinical evidence.
The device must conform to relevant Bureau of Indian Standards (BIS) standards, where notified for that device category.
Documents Required for Form MD-7 Application
The technical documentation required is specified in Part II/Part III of the Fourth Schedule of the Medical Devices Rules, 2017. In practice, applicants typically prepare:
Constitution details of the firm — Memorandum of Association (or partnership/proprietorship documents), along with details of partners/directors.
Proof of ownership or a sale/rent deed for the manufacturing premises.
Building layout plan showing room dimensions and equipment placement across the manufacturing facility.
Site Master File — covering general information, personnel, premises and facilities, equipment, sanitation, storage, documentation, and any contract activities.
Device Master File for each product — device description, labelling, risk management data (per ISO 14971), verification and validation data, biocompatibility, stability, clinical evidence, and sterilisation data as applicable.
Performance evaluation report, for in-vitro diagnostic (IVD) devices.
Declarations of the Manufacturing Chemist and Analytical Chemist, with qualification, experience, and appointment documents.
Undertaking that the manufacturing site complies with the Fifth Schedule Quality Management System requirements.
Organisation identity proof (UDYAM registration, PAN, etc.) and fee payment receipt.
Step-by-Step Process: From MD-7 Application to MD-9 Grant
Confirm your device's classification as Class C or Class D under the Medical Devices Rules, 2017, and check whether it falls under a notified device category.
Set up the manufacturing site to comply with Fifth Schedule Quality Management System requirements, and prepare the Site Master File and Device Master File for each product.
Appoint qualified technical staff — manufacturing chemist, analytical chemist, or equivalent — to oversee production and quality control.
Register on the CDSCO SUGAM/MD Portal and complete Form MD-7 online with all supporting documents.
Pay the prescribed government fee for the manufacturing site and each distinct device.
Submit the application; a nodal officer at CDSCO assigns it to a reviewing officer for scrutiny.
The Central Licensing Authority arranges an inspection of the manufacturing site — by medical device officers, a notified body, or both — typically within 60 days of the application date.
If the inspection raises a Non-Conformance (NC), respond with an NC closure report and supporting evidence through the SUGAM portal.
Once the inspection report is satisfactory, the Central Licensing Authority grants the manufacturing license in Form MD-9, typically within 45 days of receiving the report.
If the application is rejected, the CLA notifies you in writing within 45 days with reasons, and you may reapply after that period.
CDSCO Form MD-7 / MD-9 Fees
Fees for the Class C/D manufacturing license are prescribed under the Second Schedule of the Medical Devices Rules, 2017 and are commonly cited as follows:
| Fee Component |
Typical Fee |
| Manufacturing license fee (per manufacturing site) |
Rs. 50,000 |
| Fee per distinct medical device |
Rs. 1,000 |
| Retention fee (before completion of 5 years from issue) |
As per Second Schedule; keeps a perpetual license active |
Verify before you file These fee figures are widely and consistently cited across regulatory-consulting sources referencing the Second Schedule of the Medical Devices Rules, 2017. Since government fee notifications are revised periodically, confirm the current amount on the SUGAM/CDSCO MD Portal before making payment.
Validity, Retention Fee, and Renewal
A manufacturing license granted in Form MD-9 does not carry a fixed expiry date. It remains valid in perpetuity, subject to payment of the retention fee before completion of every five-year period from the date of issue, unless it is suspended or cancelled by the Central Licensing Authority.
There's no traditional "renewal" filing — a retention fee paid every 5 years keeps the license active.
Failure to pay the retention fee on time can result in the license being suspended or cancelled.
If a license is suspended or cancelled, the applicant can typically apply for reconsideration or a fresh license within 45 days of the action.
Any significant change to the manufacturing site, product composition, or technical staff generally requires a post-approval intimation or amendment to the licensing authority.
Plan ahead Because there's no automatic reminder for the five-year retention deadline, mark it on your own compliance calendar. A lapsed MD-9 license can halt commercial manufacturing and distribution until it's restored.
CDSCO Form MD-7 Timeline at a Glance
| Stage |
Typical Timeframe |
| Site setup, QMS documentation, and staff appointment |
Varies by applicant readiness |
| Form MD-7 application submission |
After documentation is complete |
| CDSCO site inspection |
Within ~60 days of application |
| NC closure (if raised during inspection) |
As specified by CDSCO; prompt response avoids delay |
| Grant of Form MD-9 license |
Within ~45 days of receiving the inspection report |
| Overall process (well-prepared applications) |
Roughly 90-180 working days; longer if documentation or GMP gaps arise |
| Retention fee due |
Before completion of every 5 years from date of issue |
Why Choose Silvereye Certifications Getting Your CDSCO MD-7 License Registration
An MD-7/MD-9 manufacturing license is one of the most rigorous approvals in India's medical device regulatory framework, precisely because Class C and D devices carry real clinical risk. The strength of your Site Master File, Device Master File, and Fifth Schedule QMS documentation — combined with genuine inspection-readiness — is what separates a smooth, on-time approval from a cycle of repeated Non-Conformance notices.
Silvereye Certifications supports medical device manufacturers end-to-end with CDSCO Form MD-7 registration — from device classification and QMS gap assessment, to preparing the Device Master File, coordinating the CDSCO site inspection, and tracking the five-year retention cycle so your MD-9 license never lapses.
Next step Planning to manufacture a Class C or Class D medical device at your own facility? Talk to Silvereye Certifications for a documentation and inspection-readiness review before you submit your MD-7 application.
Frequently Asked Questions: CDSCO Form MD-7 Registration
Form MD-7 is the application form under the Medical Devices Rules, 2017 for a manufacturing license to produce Class C or Class D medical devices at your own manufacturing premises. It's reviewed and approved by the Central Licensing Authority (CDSCO).
MD-7 is the application you file. MD-9 is the manufacturing license certificate you receive once CDSCO approves the application and the site inspection is satisfactory.
Any manufacturer who owns or fully controls a manufacturing site and wants to produce Class C (moderate-to-high risk) or Class D (highest risk) medical devices there needs to apply using Form MD-7.
MD-7 is for manufacturers using their own premises (standard manufacturing license). MD-8 is for manufacturers who don't own a facility and instead want to use another company's already-licensed premises (loan license). Both apply to Class C and D devices, but the license path and form differ.
Key documents include the Site Master File, Device Master File for each product, constitution/ownership documents for the manufacturing premises, technical staff declarations, a Fifth Schedule QMS compliance undertaking, and (for IVDs) a performance evaluation report.
CDSCO typically inspects the manufacturing site within 60 days of the application, and decides on the grant within 45 days of receiving the inspection report. For well-prepared applications, the overall process commonly runs 90-180 working days, though incomplete documentation or GMP gaps can extend this significantly.
Fee schedules commonly cite around Rs. 50,000 per manufacturing site and Rs. 1,000 per distinct medical device, under the Second Schedule of the Medical Devices Rules, 2017. Since fee notifications can be revised, confirm the current amount on the SUGAM/CDSCO MD Portal before payment.
No fixed expiry date applies. The MD-9 license remains valid in perpetuity, provided the retention fee is paid before completion of every five-year period from the date of issue.
The license can be suspended or cancelled by the Central Licensing Authority. If that happens, the applicant can typically seek reconsideration or reapply within 45 days of the action.
Yes. The Central Licensing Authority arranges an inspection of the manufacturing site — by medical device officers, a notified body, or both — before deciding on the grant of the MD-9 license.
