Start Medical Device Business in India Without CDSCO License

Written by Sudhriti M

31 May 2024

Medical devices form the backbone of the healthcare sector. They are used to perform real time diagnosis of medical conditions as well as treat and monitor them. Medical devices industry is a booming sector in India. There is a high unmet demand for affordable, effective, and high-end medical devices in India. CDSCO is the apex regulatory body for medical devices in India. Compliance with CDSCO regulatory guidelines is non-negotiable to market medical devices in India. Most medical devices mandatorily require CDSCO license. However, there are some exceptions.  Do you want to start a medical device business in India without going through the hassle of CDSCO license application? Well, you have landed in the right place. Read on to find out how you can start a medical device business without CDSCO license.

What is the potential of the Indian medical devices sector?

Before jumping into medical devices business, let us understand the potential of the Indian medical devices sector. Indian medical devices industry has witnessed a double-digit growth rate over the past few years. This indicates its importance in the health care sector. Additionally, the current market size of the medical devices sector is $11 bn. The Indian government is focused on establishing India as a global hub for manufacturing innovative, affordable, and high-quality medical devices. The current trends of the Indian medical devices industry indicate a promising future.

Some key highlights of this sector are as follows:

  1. Indian medical devices industry, one of the top 20 markets in the world, is the 4th largest market in Asia.
  2. The medical devices industry in India has been growing at a compound annual growth rate (CAGR) of 15% over the past 3 years.             
  3. The market size of this sector is expected to touch $50 Bn by the year 2025.
  4. Indian medical devices market is the fastest growing amongst the emerging markets.
  5. Make in India Campaign of 2014 has designated this market as the Sunrise Sector of India.

The government is trying to foster a robust medical device manufacturing ecosystem. Tapping into the potential of the Indian medical devices manufacturing industry, the fastest growing market, can reap high returns.

Why is now a good time to start a medical device business in India?

Now that the potential and worth of the Indian medical devices sector are clear, let us explore why is now a good time to start a medical device business.

Indian medical devices manufacturing industry is a dynamic and growing market. With infrastructural upgrades, increase in demand for high quality medical devices, government support, this sector has immense potential. The Indian medical devices manufacturing industry is rapidly transitioning from a cost-based to a value- and innovation-based industry. Industry leaders, healthcare practitioners, and policymakers are supporting innovation in this sector. The government has taken steps to create a conducive regulatory environment to promote medical device business in India. As per the latest update released by the apex regulatory body, it will be possible to manufacture certain medical devices without CDSCO license.

The following reasons are why it is a good time to start a medical device business in India:

  • Increase in demand: Population growth and increase in life expectancy has led to increase in chronic and age-related illness. Medical devices are pivotal for diagnosing, monitoring, treating, and alleviating these diseases. Moreover, increase in awareness of preventive healthcare and early diagnosis is driving the demand for medical devices. Also, India has a growing middle-class segment with increased purchasing power for high quality medical devices. Furthermore, an increasing group of individuals is investing in healthcare insurance and checkup schemes.
  • Government initiatives: The Government of India has taken several supportive steps and initiatives to promote the Indian medical devices industry. The government is focused on boosting foreign direct investments, production, and improving the efficiency and effectiveness of medical devices.
  • Latest guidelines for Class A medical devices: As per updated CDSCO guidelines, all Class A non-sterile and non-measuring medical devices have been exempted from license. This means all Class A non-sterile and non-measuring medical devices can be manufactured without CDSCO license. However, a quick CDSCO registration will be required but the documentation and lengthy process for license application have been reduced. A registration number will be generated after the successful registration of the device. The registration number will have to be printed on the label for selling these medical devices in India. Common medical devices which belong to the Class A non-sterile and non-measuring category are: scalpels, scissor/knives, walking sticks, certain bandages, eyeglasses, crutch, wheelchair, etc. However, it is important to note, all Class A sterile and measuring medical devices will require the CDSCO license. The application process for these devices remains unchanged. 
  • Conduce environment: Low labour costs and government support for medical devices have fostered a conducive medical device manufacturing environment in India. This has also made the country a popular medical device outsourcing manufacturing destination.

Want to start a medical device business in India without CDSCO license?

Yes, you have read that right. Per updated guidelines, you will now be able to manufacture and sell certain medical devices in India without CDSCO license. Central Drugs Standard Control Organization (CDSCO) monitors all medical devices manufactured, imported, and sold in India. Per previous regulations, irrespective of the medical device class, all devices required CDSCO license. Recently, CDSCO has updated its regulatory requirements to help companies establish businesses without undergoing the painstaking process of license application. By simply securing a CDSCO registration, you can start your business involving certain medical devices specified by CDSCO.

This latest change by CDSCO will help do away with the complicated process of obtaining a CDSCO license. As per the latest guidelines, you can sell/manufacture certain designated products with a simple registration. Thus, you can manufacture, sell, and even export your products without the hassle of securing a CDSCO license.

As an additional advantage, the usual documents and requirements for obtaining a CDSCO license will also be significantly reduced for the specified medical devices. The devices will be exempt from the following requirements required for obtaining a license: technical staff, fire and pollution license, industrial area requirements, etc. Furthermore, you can start the business from your home or any other existing facility without setting up an elaborate factory.

Ideas for starting a potential medical device business without CDSCO license

We have listed a few potential medical device segments in which you could start your business. The listed devices can be easily manufactured. Most importantly, they can be manufactured and sold in India without CDSCO license and only a simple CDSCO registration

  • Dental products: dental impression material, dental collar, dental excavator, dental examination kit, dental spatula (reusable and single use), dental impression material mixer, dental impression tray material, dental polishing brush, dental suction cannula, dental suction (reusable and single use), dental cotton role, dental dressing forceps (reusable and single use), tooth extraction forceps, orthodontic elastomeric agents, etc.

  • Surgical dressing products: adhesive tape, microporous paper tape, cannula fixator, absorbent cotton, surgical towel, non-sterile surgical drape, Plaster of Paris bandage, etc.

This aforementioned list provides an overview of the medical devices you can manufacture and sell without procuring a license. To get a full list of medical devices that no longer require a license but only a registration contact us. We will be more than happy to provide the full list of potential medical device business exempt from license requirements.

Pharmadocx Consultants will guide you in your medical device regulatory journey

CDSCO has specified certain medical devices, which are exempt from license. In other words, you do not need to apply for a CDSCO license. To start your medical device business in this segment, you simply have to register your product. This is a potential medical device business segment because of the absence of CDSCO license application hassle. You can focus on establishing and marketing your business instead of spending time and resources on the arduous CDSCO license application process.

We at Pharmadocx Consultants simplify the medical devices registration process. From determining regulatory requirements, identifying medical device class, and assistance in obtaining CDSCO registration, Pharmadocx Consultants is your go-to-partner. Although the specified medical devices can be manufactured without CDSCO license, registration of the products is mandatory. Without proper registration, you will face legal consequences. We will help you obtain the CDSCO registration within a short span of time. Email us at [email protected] or call/Whatsapp on 9996859227 to start your medical device journey.

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