How to Obtain a CDSCO Class A and B Manufacturing License?

Introduction

The medical device industry in India has developed at a pace that is more than anticipated. Starting with the plain wound dressing and going all the way up to the highly advanced diagnostic equipment, India currently produces a variety of equipment that is utilised in hospitals daily. However, behind every device that finds its way to a patient, there is a regulatory foundation that ensures it is safe, effective, and produced in a responsible way. The Central Drugs Standard Control Organisation (CDSCO) is the central body in this regard, which oversees the manufacturing, distribution, and importing of medical devices throughout the country. 

For any individual intending to produce Class A and B medical devices, the CDSCO licensing procedure is no longer a matter of choice; it is the initial step towards establishing a legitimate and compliant medical device enterprise. While the law behind this may seem to be technical at first glance, the actual licensing journey is quite rational once you break it down.

What are Class A & B Medical Devices?

In the Medical Devices Rules, 2017, the devices are categorised into 4 groups: Class A, B, C and D, wherein specific licensing routes are prescribed for each category. It is based on their intended use and risk profile, as prescribed under the First Schedule of the Medical Devices Rules, 2017. This risk-based approach will make sure that the level of regulatory control is proportionate to the potential safety concerns associated with each device.

Class A devices - These devices are of the lowest-risk category. These include products like examination gloves, stethoscopes, basic thermometers, and other items that typically come into contact only with intact skin. Their design is mechanically simple, and they generally do not rely on electrical components or complicated engineering. Example - foetal stethoscope, medical examination gloves, clinical colour change thermometer, hydrophilic wound dressing.

Class B devices - These devices, on the other hand, carry a slightly higher risk; they may be invasive for a short period, interact with mucous membranes, or demand more vigorous safety measures. Products like surgical gloves, urethral catheterisation kits, and bronchoscopes fall under this category.

A recent CDSCO directive also mandates manufacturers to verify their device classification using the official CDSCO classification list. If the device is not listed, a request for classification must be filed with the central licensing authority before applying for a manufacturing license.

Who Issues the Manufacturing License?

Licensing in India works under a dual-authority system:

• Class A and B manufacturing licenses are issued by the State Licensing Authority (SLA), the regulatory body of the state where your manufacturing site is located.

• Class C and D licenses are issued by the Central Licensing Authority (CLA).

The SLA is also responsible for on-site inspections, compliance reviews, loan licenses, and enforcement actions for class A and B licenses. This decentralised approach allows for efficient supervision and faster decision-making.

In a regulatory communication dated 23 October 2025, CDSCO reinforced the requirement that device classification must be verified against the official classification list by CLA before issuance of class A or B manufacturing licenses by SLAs. The circular further clarified:

• If a device is not present in the official classification list, the manufacturer must first submit a request for determination of classification to the CLA.

• SLAs must ensure that risk classification is correct and supported by the first schedule rules before processing an MD-3 application.

The directive enhances uniformity in regulations and ensures that manufacturers take the right licensing pathway depending on the actual risk profile of the device.

Fees for CDSCO Class A & B Manufacturing License

The fee structure is quite cost-effective to promote more manufacturing within the country. The fee schedule for Class A and Class B manufacturing licenses is stipulated in the Second Schedule to the Medical Devices Rules, 2017, as last updated:

The license remains valid in perpetuity, provided that retention fees (the same amounts listed above) are paid once every 5  years. Failure to pay retention fees results in automatic cancellation.

Audit fees for Class B devices are payable directly to the notified body and can vary depending on the complexity and size of the facility.

Eligibility for CDSCO Manufacturing License

In order to be licensed, the applicant should meet the statutory requirements in respect to legal status, infrastructure, quality systems, technical competence and documentation. These requirements are mostly established in pursuant with rules 20-23 and the Fourth and Fifth Schedules.

1. Indian Legal Entity

This may be a company, partnership, LLP or a proprietorship. A foreign manufacturer cannot directly seek registration of the CDSCO site. They need to do so instead by assigning an authorised Indian agent who is operating in India and registered with CDSCO. This agent will serve as a legal representative and will be in charge of applying, communication management with CDSCO and assuring that all Indian regulations are adhered to.

2. Adequate Manufacturing & Testing Facility

Your Manufacturing site must meet the infrastructure and operational standards required under MDR, 2017. This includes having sufficient space, a controlled and hygienic work environment, and validated equipment. At a minimum, the facility should provide:

• Segregated production, testing, and storage areas

• Properly managed utilities such as ventilation, power supply and water

• Documented equipment details, including calibration records and process validation

• Established storage, sanitation and waste management systems

3. Quality Management System (QMS) Compliance

Your QMS should comply with Fifth Schedule requirements covering:

• Document control

• Internal audits and corrective and preventive actions 

• Environmental controls

• Testing procedures

• Manufacturing process controls

• Staff training and competence

Although the ISO 13485 certification is not a mandatory process in India, it is generally believed to be the smoothest and most globally accepted process to fulfil the Fifth Schedule requirements.

4.  Competent Technical Staff (Rule 22)

Assign at least one qualified technical individual who will oversee manufacturing operations and guarantee adherence to MDR, 2017. The person should qualify under one of the following qualification routes:

1. The first being a degree route

Baccalaureate degree in Engineering, Pharmacy or Science (relevant subject), and 

At least 2 years of experience in the manufacturing or testing of medical equipment.

                               OR

2. The second is through a Diploma 

Diploma in Engineering, Pharmacy or Science (relevant subject), and 

At least 4 years of experience in the manufacturing or testing of medical equipment.

The technical individual should also be full-time and based at the manufacturing location. They should be knowledgeable and competent in device-specific manufacturing processes and quality system requirements.

Documents Required for CDSCO Class A & B Manufacturing License

Your application Form MD-3, accompanied by a complete set of documents required under the Fourth and Fifth Schedules.

1. Corporate Documents

• Company incorporation/registration

• PAN, GST, and authorisation letters

• Proof of premises (ownership/lease)

2. Proof of Premises & Tenancy/Ownership

The proof of ownership or valid lease agreement for the manufacturing site, recent utility bills, site layout plan, etc., must be submitted.

3. Plant Master File (PMF) - As per Appendix I (Fourth Schedule)

The PMF should describe your site infrastructure, staffing details, quality control, sanitation SOPs, equipment list, storage, internal auditing and complaint management procedures.

4. Device Master File (DMF)

Prepare a separate DMF for each device. It must include:

• Device description and specifications of the device

• Labelling and IFU

• Risk management documentation as per the International Organisation for Standardisation (ISO) 14971 

• Manufacturing process flow

• Verification and validation reports

• Clinical evidence (if applicable)

5. Quality Management System Documentation

• QMS Manual or overview

• SOP index

• Training records

• Internal audit reports

• Calibration & maintenance records

• CAPA records

• Signed undertaking of Fifth Schedule compliance

6. Technical Staff Documentation (Rule 22)

• CV, qualification certificates, and experience proofs

• Appointment letter indicating full-time engagement

7. Notified Body Audit Report (Class B only)

• Pre-licensing audit report confirming compliance with Fifth Schedule and PMF & DMF requirements.

8. Test Reports & Certificates

• Laboratory test reports, signed and dated by the responsible person

• Biocompatibility test reports (ISO 10993 series), sterilisation validation reports (if applicable)

• Certificates of analysis (CoA) for raw materials & finished product

9. Additional Documents 

• Free Sale Certificate (for imported components)

• Power of Attorney (if filing through an agent)

• Environmental monitoring records; Transmissible Spongiform Encephalopathy (TSE)/Bovine Spongiform Encephalopathy (BSE) certificates

10. Fee Proof & Declarations

• TR-6 or Online payment receipt (?5,000 per site + ?500 per device)

• Declarations of authenticity and consent for inspections

• Every activity that is required by MDR 2017 should be signed and uploaded.

Process to Obtain Class A & B Manufacturing License

Step 1. Confirm your device classification

The first step is to check whether your device appears in the CDSCO classification list in order to determine further steps. If not, you request a classification from the Central Licensing Authority. This is a crucial step because everything that follows depends on whether the device is classified in Class A or B.

Step 2: Prepare your facility and QMS.

Before even opening the portal, manufacturers typically conduct internal audits to ensure their QMS, equipment, and documentation meet the required standards. Some may pursue ISO 13485 certification at this stage.

Step 3: Register on the SUGAM portal.

This is the online platform where all applications are lodged. You need to upload your corporate documents, wait for approval, and then access your personalised dashboard.

Step 4: Submit the MD-3 file with all the attached documents.

Here, your PMF, DMF, QMS records, staff technical information and test reports are uploaded.

The form captures details of the site, the devices under production, the equipment in use, and the quality controls in place, etc.

Step 5: Pay the government fees.

The portal will generate the appropriate fee amount depending on the number of devices you manufacture. After payment, the application goes through the review process.

Step 6: SLA scrutiny and deficiency correction.

Regulators review your submission. If anything needs clarification, they issue a deficiency letter. At this stage, SLA may approve or reject the licensing.

Step 7: Class B device audit by notified body.

This is one of the most significant steps in the case of Class B applicants. A notified body, registered by CDSCO, visits the manufacturing premises to ensure that QMS is implemented. Their report carries significant influence in determining the final decision of the SLA.

Step 8: License approval

Once the SLA is satisfied,  it grants the manufacturing license in Form MD-5, either directly in the case of Class A or by the audit report in the case of Class B. The license remains valid provided that the retention fees are paid every five years.

Step 9: Post-approval duties

Manufacturers are also required to maintain their QMS, report adverse events, periodically audit and maintain detailed batch records even after the license is received. These commitments guarantee further adherence, ensuring safety.

The entire process generally takes between 4-6 months for Class A and 6-8 months for Class B, though this can vary slightly by state.

Conclusion

The CDSCO Class A and B licensing process might seem to be a challenge, but it eventually becomes a driver of more robust and responsible manufacturing. MDR 2017 presents a clear, systematic and risk-oriented framework that makes sure that only safe and reliable medical devices get into the Indian market. It improves the general standard of the industry by substituting the old divided system with a coherent system based on proper classification, extensive documentation, a complaint quality management system and a skilled technical control staff.

The framework requires accuracy at each phase, which includes proper classification, strict documentation, and uniform QMS application, which develops a predictable and disciplined compliance environment. By so doing, it protects not only the patients but also the manufacturers, who benefit in terms of increased credibility, easier exports and increased investor confidence. To manufacturers, the license is no longer a formality of regulation but a badge of credibility. It is India’s way of signalling to global markets: “Our medical devices meet world-class standards”.

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Author:

YOSHITA SHARMA
Indore, Madhya Pradesh
NMIMS, Indore BBA LL.B. (Hons.), Final Year