A medical-device manufacturer can have its machinery installed, production team recruited and product almost ready for launch – and still discover that the regulatory route was planned incorrectly.
Consider an illustrative case. A startup develops a patient-monitoring device and initially treats it as a straightforward low-risk product. During licence preparation, its intended use places it in a higher risk class. The application form, authority, technical dossier and inspection route all change.
This is why obtaining a CDSCO medical device manufacturing licence should begin with classification and regulatory planning, not simply with portal filing.
India regulates medical devices under the Medical Devices Rules, 2017. Devices are classified according to risk as Class A, B, C or D. Manufacturing of Class A devices other than non-sterile/non-measuring devices and Class B devices is licensed through the relevant State Licensing Authority, while Class C and D manufacturing applications are handled by the Central Licensing Authority.
For manufacturers, the first task is therefore to identify what is being manufactured, its intended use, its correct risk class and the applicable licensing route.
A medical device manufacturing licence authorises a manufacturer to manufacture specified regulated medical devices for sale or distribution from an approved manufacturing site under the Medical Devices Rules, 2017.
The Rules classify medical devices as:
| Class | Risk level | Normal manufacturing route |
| Class A | Low risk | Registration if non-sterile and non-measuring; otherwise MD-3 → MD-5 |
| Class B | Low-moderate risk | MD-3 → MD-5 |
| Class C | Moderate-high risk | MD-7 → MD-9 |
| Class D | High risk | MD-7 → MD-9 |
The Rules establish the four risk classes and the different A/B and C/D manufacturing pathways. G.S.R. 777(E) created the specific registration-based exemption for Class A non-sterile and non-measuring devices.
This means that saying “we need a CDSCO licence” is not enough. The applicant must establish the correct device classification and authority before preparing the application.
Not directly.
For Class A devices requiring a manufacturing licence and Class B devices, Rule 20 requires the application to be submitted to the State Licensing Authority. The application for a standard manufacturing licence is Form MD-3, and the licence is issued in Form MD-5. A loan licence uses Forms MD-4 and MD-6.
For Class C and Class D devices, the application is submitted to the Central Licensing Authority in Form MD-7, with the licence granted in Form MD-9. The corresponding loan-licence route uses MD-8 and MD-10.
CDSCO also reiterated this authority split in its November 2025 circular addressing medical-device procurement.
| Question | MD-5 route | MD-9 route |
| Device class | Class A requiring licence / Class B | Class C / Class D |
| Application | MD-3 | MD-7 |
| Licence issued | MD-5 | MD-9 |
| Main authority | State Licensing Authority | Central Licensing Authority |
| Pre-grant facility assessment | Depends on class; Class B requires Notified Body audit | Manufacturing-site inspection required |
| QMS compliance | Required | Required |
These distinctions are established under Rules 20-25 of the Medical Devices Rules.
This is one of the most frequently missed distinctions in manufacturing compliance.
The Medical Devices (Sixth Amendment) Rules, 2022 exempt Class A non-sterile and non-measuring medical devices from the relevant manufacturing licensing provisions, provided the manufacturer registers the device through the Online System for Medical Devices under Chapter IIIB.
For registration, the Rules require information including the manufacturing-site details, generic and brand name where applicable, model, intended use, material of construction, dimensions and shelf life where applicable. The manufacturer must also provide specified undertakings and self-certification relating to safety, performance and applicable standards.
Therefore, a manufacturer should not automatically file MD-3 merely because the product has been identified as Class A.
The additional question is:
Is the Class A device sterile or measuring?
That answer can change the regulatory pathway.
Medical-device classification should start with the exact intended use, not merely the commercial name of the product.
The Medical Devices Rules provide classification principles for non-invasive, invasive, implantable, active and in-vitro diagnostic devices. CDSCO also publishes and updates device-specific classification lists.
A useful classification file should record:
The classification memo should then be reconciled with the Device Master File and product labelling. This is a practical recommendation rather than a separate statutory form, but it reduces the risk of the same device being described differently across application documents.
Once classification is confirmed, determine whether the business requires a standard manufacturing licence, loan licence, test licence or another permission.
For commercial manufacturing, the core routes are MD-3/MD-5 for the applicable Class A and Class B devices and MD-7/MD-9 for Class C and D devices. CDSCO’s official regulatory pathway also identifies MD-12/MD-13 for manufacture for testing or evaluation.
For an investigational medical device or new IVD, other permissions may be required before a commercial manufacturing licence can be granted. Rule 25 specifically refers to prior permission in MD-27 or MD-29, where applicable.
A manufacturing licence is not evaluated only on the product.
The regulator also assesses whether the manufacturing system can consistently produce a compliant device.
Rule 22 requires the manufacturing site to comply with the Quality Management System requirements in the Fifth Schedule. It also prescribes qualifications and experience for competent technical staff supervising manufacturing and testing activities.
The Site or Plant Master File covers subjects including the manufacturing activities, organisation and personnel, premises, ventilation, water systems where applicable, major production and quality-control equipment, calibration, sanitation, production controls, storage, documentation, complaints, field safety corrective actions and internal audits.
A certificate or SOP folder alone therefore does not establish licence readiness. The actual facility, people, processes and records need to correspond with what is described in the application.
The Fourth Schedule specifies the documents used for manufacturing licence applications.
For Class B, C and D devices, this includes manufacturing-site constitution details, the Site or Plant Master File, Device Master File, Essential Principles checklist, relevant test-licence information where applicable and an undertaking regarding Fifth Schedule compliance. Additional requirements apply for IVDs.
For applicable licensed Class A devices, the required documents include product description and intended use, specifications and variants, materials where applicable, working principle, labelling/IFU material, relevant safety information, Plant Master File, constitution details, Essential Principles checklist and the QMS undertaking.
The Device Master File can contain detailed information on product specifications, variants, materials, design, manufacturing process, labelling, validation, Essential Principles and risk analysis.
| Document / evidence | Business owner | Regulatory consultant | Technical/QMS team |
| Company constitution records | Provide originals | Review consistency | – |
| Device classification information | Confirm intended use | Prepare regulatory rationale | Validate technical facts |
| Plant Master File | Provide facility data | Structure and gap-review | Own technical content |
| Device Master File | Provide design and test evidence | Regulatory review | Own product evidence |
| Essential Principles checklist | Supply standards/evidence | Map requirements | Verify technical conformity |
| SOPs and QMS records | Implement | Readiness review | Create, operate and maintain |
| Application forms | Authorise | Prepare/file where engaged | Verify technical fields |
| Audit/inspection evidence | Ensure availability | Coordinate readiness | Demonstrate implementation |
The division above is a recommended project-management approach. Regulatory responsibility remains with the applicant and licence holder.
The assessment route varies significantly by class.
For a licensed Class A device, the Rules state that a manufacturing-site audit is not necessary before grant of the licence. The required audit by a registered Notified Body is instead to be carried out within 120 days from licence grant.
For Class B, the manufacturing site must conform to the Fifth Schedule QMS and applicable standards, with conformity verified through a Notified Body audit before licence grant. The Rules provide for the audit within 90 days of application, followed by submission of the audit report to the SLA.
For Class C and D devices, the Central Licensing Authority causes the manufacturing site to be inspected. Rule 23 provides for an inspection team comprising at least two Medical Device Officers, with an expert or Notified Body involved where appropriate.
The practical lesson is simple: inspection preparation should start before filing, not after an inspection date is received.
The Second Schedule presently specifies the following manufacturing licence fees:
| Licence category | Site fee | Fee per distinct device |
| Class A requiring licence / Class B | ₹5,000 | ₹500 |
| Class C / Class D | ₹50,000 | ₹1,000 |
The same Schedule specifies corresponding licence-retention fees for the manufacturing site and each distinct medical device.
These are government fees under the Rules. Consultant charges, laboratory testing, QMS implementation, validation, facility modifications and Notified Body-related commercial costs are separate and depend on the project’s actual scope.
It is better to use the statutory processing stages than advertise a universal approval period.
For the applicable Class A manufacturing route, the Rules provide for the State Licensing Authority to grant or reject the application within 45 days, subject to compliance with the prescribed requirements.
For Class B, the Rules provide for the Notified Body audit within 90 days of application, the audit report within 30 days after completion of the audit, and the SLA’s decision within 20 days after receipt of that report.
For Class C and D applications, the Rules provide for technical scrutiny, manufacturing-site inspection and a subsequent licensing decision. The Central Licensing Authority’s scrutiny period is stated as 45 days; Rule 23 provides for site inspection within 60 days of application, and Rule 25 provides for grant or rejection within 45 days after receipt of the inspection report.
These figures should not be added together and advertised as a guaranteed end-to-end approval timeline. Rectifiable deficiencies, additional evidence and application-specific issues can affect the actual process; Rule 21 specifically addresses deficiencies during Class C/D scrutiny.
Not exactly.
Under Rule 29, MD-5, MD-6, MD-9 and MD-10 licences remain valid in perpetuity unless suspended or cancelled, provided the prescribed licence-retention fee is paid before completion of every five-year period from the date of issue.
This distinction matters for website content. It is more accurate to say:
“The licence has perpetual validity subject to the prescribed retention-fee requirements and continued regulatory compliance.”
rather than simply calling it a five-year licence.
Before filing, a manufacturer should be able to answer yes to the following:
If several answers are “no”, filing immediately may create avoidable regulatory queries.
One common problem is treating product classification as a marketing exercise rather than a regulatory exercise. A small change in intended use can affect the risk assessment and therefore the licensing route.
Another is preparing the Plant Master File and Device Master File independently. If one file describes a sterilisation method, manufacturing step, test method or facility that is inconsistent with the other, the dossier becomes difficult to defend during scrutiny.
Manufacturers should also avoid assuming that holding an ISO-related quality certificate by itself replaces the Indian requirements. The Medical Devices Rules independently require conformity with the Fifth Schedule, appropriate technical documentation and applicable product standards.
Finally, businesses should avoid treating the audit or inspection as a presentation exercise. The manufacturing site, records, equipment, calibration, quality-control arrangements and personnel should substantiate what has already been declared in the regulatory dossier.
Consider an Indian company developing two healthcare products at the same facility.
Product 1 is confirmed as a Class A non-sterile and non-measuring device. Product 2 is classified as Class C because of its intended clinical function.
The company cannot simply place both products into one generic “CDSCO registration” workflow.
Product 1 must be assessed against the Class A registration provisions, while Product 2 follows the MD-7 to MD-9 Central Licensing Authority manufacturing route with the applicable technical review and site inspection.
The business value of classification work is therefore not paperwork reduction. It determines the entire regulatory project structure.
A consultant’s most useful role starts before the application is filed.
Green Permits can support manufacturers with:
The objective should not be to promise approval. The objective should be to submit a technically consistent application and prepare the facility to demonstrate compliance with the Medical Devices Rules.
A manufacturer should not press “submit” until the device, dossier and factory tell the same regulatory story.
Classification determines the authority. The authority determines the application route. The device class determines the degree of scrutiny, audit or inspection. The dossier must then substantiate how the product is designed, manufactured, tested and controlled.
That is the practical foundation of a successful CDSCO medical device manufacturing licence project.
For manufacturers planning a new medical-device unit, adding a product or preparing an MD-5 or MD-9 application, Green Permits can conduct a pre-application review to identify regulatory and documentation gaps before filing.
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