Guide to Starting a Class A Medical Device Business in India

Written by Sudhriti M

21 May 2024

Medical devices form the backbone of the healthcare sector. Medical devices sector of India has been recognised as the sunrise sector. Given the potential of India’s medical device industry, entities are trying to establish a medical device manufacturing business in India. Among various CDSCO medical device classes, Class A medical devices have low to almost no risk. Starting a Class A medical device business in India can be profitable and has a bright future. Are you planning to start a Class A medical device business in India? Well, we have got you covered. Read on to find out about Class A medical device in India and how to start a business focused on it.

What are Class A medical devices?

CDSCO has classified medical devices into various risk classes depending on their intended use and risk level. CDSCO medical device classification is as follows:

  • Class A: Low risk medical devices
  • Class B: Low to moderate risk medical devices
  • Class C: Moderate to high-risk medical devices
  • Class D: High risk medical devices

This medical device classification system helps ease the CDSCO medical device manufacturing business license registration process. The application process varies depending on the medical device class. Different medical device classes have different application forms. The applicant can simply follow the process applicable for the CDSCO class to which their medical device belongs to.

Among the various medical device classes defined by CDSCO, Class A medical devices have low to almost no risk.

Some examples of Class A medical device in India are as follows:

Surgical dressing, Stethoscopes, Non-powered surgical instruments (e.g., forceps and scalpels), Thermometers, Hot water bags, Walking aids (e.g., canes and crutches), Bandages and dressings, Alcohol swabs, Elastic stockings, Spectacles, contact lenses, etc.

Regulatory authority

Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for all medical devices, pharmaceuticals, and cosmetics in India. CDSCO functions under the Directorate General of Health Services, Ministry of Health and Family Welfare. The CDSCO functions with the help of two arms: Central Licensing Authority (CLA) and State Licensing Authority (SLA). The State Licensing Authority (SLA) oversees Class A and B medical device manufacturing business in India. Hence, businesses focused on Class A medical device in India will be granted licenses by SLA to manufacture and sell their products. 

Regulatory compliance

CDSCO regulates the safety, quality, and efficacy of medical devices marketed in India to promote patient safety. The main goals are effective healthcare delivery and protection of public health. Hence, compliance with the Indian medical device regulatory guidelines is mandatory prior to starting a Class A medical device business. Failure to comply with the regulatory guidelines can lead to serious legal consequences. CDSCO works under the purview of Medical Devices Rules, 2017. Entities focused on medical device manufacturing business or medical device import business will require a CDSCO registration.

  • Manufacturing license: The MD5 license will be required for manufacturing Class A medical device (measuring and sterile) in India
  • Import license: The MD15 license will be required for importing Class A medical devices (measuring and sterile) into India.

How to start a Class A medical device business in India?

  1. In-depth market research: The first step is to perform in-depth market research and identify the target customers. It is important to understand the market opportunity before launching your Class A medical device business. This will help you understand market trend and customer needs. Then, you can shape your business accordingly.
  2. Business plan: The second step would be to chalk out a detailed business plan based on your market research findings. You need to have a proper plan of action prior to launching your medical device business. Everything from suppliers, staff, finance to marketing strategy should be drafted in the business plan.
  3. Funding: To start a medical device business, you need to acquire sufficient funding. The financial plan should be clear. This could require pitching your business to investors for funding or taking loans. The revenue stream and how the incurred costs will be handled need to be decided upon.
  4. Identifying dependable suppliers: Identifying and building a strong relationship with dependable suppliers will ensure your business thrives. You need a steady supply of equipment, materials, spare parts, and devices to run your business. It is important to find suppliers of good quality products to ensure you can deliver high quality medical devices.
  5. Regulatory compliance: To enter the Indian medical device market, you need to abide by the medical device regulatory guidelines. CDSCO registration is mandatory to market a Class A medical device (measuring and sterile) in India. For Class A medical device manufacturing business, the MD5 license will be required. For a medical device import business, the MD15 license will be required. CDSCO registration also demonstrates the medical device business’s commitment to quality and safety.

Common hurdles faced by medical device manufacturing or import businesses

  • Keeping up with rapid technological advancement: Medical devices industry is dynamic and rapidly evolving. The medical devices are constantly being updated with the latest technologies to ensure improved patient care. Selling medical devices with outdated technology will put you out of business. Thus, it is important to stay abreast of the latest advancement in medical devices.
  • Meeting customer expectation: Individuals have become more aware of the latest and advanced medical devices available. Public understanding of preventive healthcare has improved. Hence, medical device companies have to continuously strive to meet customer expectations.
  • Regulatory compliance: To start a medical device manufacturing business or even medical device import business, regulatory compliance is a must. Meeting certain regulatory requirements is necessary to obtain CDSCO registration. Registering your product with CDSCO is mandatory, to market medical device in India. Selling your product without CDSCO registration will attract hefty fines and severe legal consequences.
  • Maintaining product quality:  Quality of the medical devices affects its function. Given the important role medical devices play in the healthcare sector, maintaining their quality is critical. Failure to sell high quality medical devices will affect the patient’s health and tarnish the company’s reputation. Thus, to stay in business it is essential that each medical device you sell is of the highest quality.

CDSCO registration for Class A medical device in India

Stringent regulations are in place for all medical devices entering the Indian market. CDSCO registration for medical devices is a must to indicate compliance with Indian medical device regulations. To obtain CDSCO registration, an application using the correct form and multiple supporting documents need to be submitted. Preparing supporting documents and arranging them per CDSCO requirements is a tedious task. Additionally, the CDSCO registration application process is arduous and painstaking. Also, if any queries are raised, they need to be responded to. All of this requires in-dept understanding of the CDSCO regulations.

With over 27 years of experience and more than 600 clients, the Pharmadocx Consultants team has extensive knowledge of the CDSCO regulations. We leverage our expertise and industry knowledge to help medical device businesses obtain medical device manufacturing, test, and import license. Pharmadocx Consultants can help you obtain CDSCO registration and the necessary license for Class A medical device business in India. To simplify and speed up your CDSCO registration process, call/Whatsapp us at 9996859227 or drop an email at [email protected]. We shall be more than happy to help.

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