Planning to start a disposable medical devices manufacturing business in India? Well, you have landed in the right place. This blog has got you covered from potential for the business to CDSCO license required.
Potential for starting a disposable medical devices manufacturing business in India
- Healthcare expansion: Rising insurance penetration, Ayushman Bharat scheme, and private hospital investments are driving demand for affordable, locally made disposables.
- Expanding market demand: India’s healthcare sector is growing rapidly, driven by rising hospital infrastructure, insurance coverage, and government health schemes. Disposable devices like syringes, gloves, and catheters are consumed in massive volumes daily. This creates a steady, recession‑resistant demand base for local manufacturers.
- Import substitution opportunity: Currently, India imports nearly 70–80% of its medical devices, including disposables. Domestic production can reduce dependency on imports, lower costs, and improve supply chain resilience. Manufacturers who localize production gain a competitive edge in pricing and availability.
- Government incentives and policy support: The Production Linked Incentive (PLI) scheme and MedTech Parks provide subsidies, infrastructure, and R&D support. CDSCO is harmonizing regulations with US FDA and EU MDR, boosting credibility of Indian‑made devices. These initiatives lower entry barriers and encourage investment in manufacturing.
- Export growth potential: Global demand for affordable, quality disposables is rising, especially in emerging markets. India’s regulatory alignment and cost‑effective manufacturing position it as an attractive exporter. Companies can leverage CDSCO approvals to access international markets with competitive pricing.
CDSCO regulations for disposable medical device in India
To launch a disposable medical device manufacturing business in India. you have to comply with CDSCO medical device regulations.
CDSCO risk-based classification for disposable medical devices
Based on associated risk level, CDSCO has classified medical devices into four classes (A, B, C, and D) for the ease of registration and licensing. The classification helps entities understand the registration process and regulatory requirements for their products.
Disposable medical devices encompass everything from simple bandages to sterile surgical catheters. Hence, for the purpose of CDSCO licensing, CDSCO has classified disposable devices into four classes. The CDSCO disposable medical device class will determine the CDSCO license required. We have provided an overview of the CDSCO disposable medical device classification system.
| CDSCO Class | Risk Level | Examples of Disposable Devices | Regulatory scrutiny |
| Class A | Low risk | Disposable abdominal support/belt/binder (non-sterile), Absorbent cotton wool (non-sterile), Absorbent underpad (non-antimicrobial), and Single-use acupressure applicator | These are mostly low-risk disposables. Exempt from stricter licensing provisions and high levels of regulatory scrutiny. |
| Class B | Low–moderate risk | Disposable hypodermic syringes, Disposable surgical gloves, Disposable infusion sets, Disposable blood collection tubes | Involves invasive use or contact with blood/tissues. Requires strict licensing and QMS compliance. |
| Class C | Moderate–high risk | Disposable dialysis catheters, Disposable cardiac catheters, Disposable endotracheal tubes | Devices used in critical procedures with higher patient risk. Requires audit and stricter CDSCO oversight. |
| Class D | High risk | Disposable pacemaker leads, Disposable implantable stents, Disposable heart valves | Life-supporting or implantable disposables. Highest regulatory scrutiny, requiring CDSCO approval and full compliance audits. |
CDSCO license for manufacturing disposable medical devices in India
The CDSCO disposable medical device class will determine the CDSCO license required.
- CDSCO Class A and Class B disposables: You must file Form MD-3 to apply for a manufacturing license. The final license for manufacturing CDSCO Class A and Class B disposable medical devices is granted on Form MD-5.
- CDSCO Class C and Class D disposables: You must file Form MD-7 to apply for a manufacturing license. The final license for manufacturing CDSCO Class C and Class D disposable medical devices is granted on Form MD-9.
Depending on the CDSCO class, different authorities are responsible for granting CDSCO license for disposable medical devices.
- State Licensing Authority (SLA): SLA is responsible for Class A and B disposable devices in India.
- Central Licensing Authority (CLA): CLA is responsible for Class C and D disposable devices in India.
The licenses are valid indefinitely as long as they are not cancelled by the regulatory body officials. However, a license retention fee is to be paid every five years.
Necessary documents for CDSCO disposable medical device license
- Sale Deed / Rent Deed proving legal ownership of the manufacturing facility.
- Building layout with dimension presenting the dimensions of each room and the location of all equipment in the manufacturing facility. This presents a detailed drawing of the medical device manufacturing facility.
- Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
- Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the devices.
- Plant master file
- Device master file
- Audit reports
- ISO 13485 Certificate validating the manufacturing facility meets international criteria for quality management systems.
- Medical device test license. This will be required in case you need to test your product before launching it in India.
- Certificate of Analysis of 3 Consecutive Batches. This document will certify that the first 3 batches of the manufactured disposable devices meet the required quality benchmarks.
- Document supporting compliance with the environmental regulatory requirements.
The above list provides an outline of the supporting documents. For the exact list of documents and document preparation support, the Pharmadocx Consultants team is ready to help you.
8-step guide to obtain CDSCO license for disposable medical devices
- Login/Signup on CDSCO’s online registration portal, SUGAM.
- Prepare the CDSCO medical device manufacturing license application as per the requirements of the CDSCO disposable medical device class.
- Fill in the correct application form.
- Collate the necessary supporting documents required for licensing.
- Submit the application online and pay the required registration fees.
- The regulatory officials will review and evaluate your application.
- The regulatory officials will perform an audit and inspect the manufacturing facility as per regulatory requirements for your product’s CDSCO class.
- If all the necessary criteria are fulfilled, CDSCO will grant the pertinent license. This will permit you to manufacture, sell, and distribute disposable medical devices in India.
Pharmadocx Consultants will help you easily obtain your CDSCO license for disposable medical devices
With an in-depth understanding of the CDSCO regulations, Pharmadocx Consultants is dedicated to simplifying your path to securing the CDSCO license for disposable medical devices in India. We leverage our expertise and industry knowledge to help medical device manufacturers obtain medical device licenses in India.
- Documentation support: Different classes of disposable medical devices have different documentation requirements. We will help you prepare the necessary documents for registering your disposable devices in India.
- License application support: We will oversee the complex license application process. Our team has proven expertise in license application.
- Mock audit support: Pharmadocx Consultants conducts mock audits to help their clients identify any noncompliance or shortcomings. Our mock audit service will prepare you for the inspection and audit carried out by the regulatory officials. Additionally, we provide audit document preparation support.
- License grant support: Our service does not end with assistance for license application. We provide license application and document preparation support as well as assist in procuring the license. Our team of experts will help you respond to any query raised by the officials. We will monitor the application process till the license is granted.
Manufacturing disposable medical devices in India is a potential business. However, to enter the Indian medical device manufacturing sector, you have to register your product with the CDSCO. The Pharmadocx Consultants team will help you obtain the CDSCO disposable medical device license in India. Our team provides tailored support depending on your needs and will guide you through the steps of the licensing process. For an easy licensing and regulatory journey, drop an email at [email protected] or call/Whatsapp on 9996859227.
