CDSCO Registration for Defibrillators in India

Written by Sudhriti M

15 May 2024

Defibrillators are lifesaving medical devices for emergency situations. With the rise in sudden cardiac arrest incidences in India, defibrillators are in high demand. Medical device companies are viewing this increased demand as a potential business option. With supportive government policies being implemented, this demand is expected to rise. The Indian market for defibrillators is profitable. To strictly control this market, CDSCO has regulations for defibrillators in India. This blog will provide insights into the Indian market for defibrillators and CDSCO registration for defibrillators.

What are defibrillators?

Defibrillators are devices used to send a pulse or electric shock to the heart to restore the heartbeat to normal. These lifesaving medical devices can be used to treat various heart conditions, such as ventricular fibrillation or ventricular tachycardia. When the heart beats faster or slower than normal, then this condition is known as arrythmia. These electronic devices can be used to correct abnormal heartbeat or arrythmia. In case the heart stops beating, defibrillators can be used to restart the heartbeat. In an emergency situation, defibrillators can be used to save the lives of individuals suddenly experiencing a cardiac arrest.

Types of defibrillators:

  • Implantable cardioverter defibrillators
  • Wearable cardioverter defibrillators
  • Automated external defibrillators

Indian market for defibrillators

India has witnessed an increasing prevalence of cardiac arrests and various heart conditions. There has been a rise in deaths caused by heart attacks. Defibrillators have a critical role in saving lives of individuals who are experiencing a sudden cardiac arrest. Hence, the Indian government has implemented various policies to increase accessibility and availability of defibrillators. The policies aim to install defibrillators in public places, such as offices, malls, schools, government buildings, airports, etc. Hence, they can be used to restore the heartbeat of individuals experiencing sudden cardiac arrests in public places. State governments have already started acting on these policies. The government bodies have ordered the installation of defibrillators in various public places. This has triggered an increased demand for defibrillators, thereby boosting the Indian market for defibrillators.

The automated external defibrillators are potential live saving devices in emergency situations. Factors, such as increase in cardiac arrest incidences, government policies, and increasing awareness, have led to the growth of the Indian market for defibrillators. Over the next five years, the Indian market for defibrillators is expected to grow at a CAGR of 8.1%. Globally, India is the largest importer of these life-saving medical devices. 

Increase in life expectancy, stress, and other factors are increasing cardiac arrest incidences in India. Improvement in healthcare sector, public awareness, and government support are all fuelling the demand for these lifesaving medical devices. As automated external defibrillators in public areas have lifesaving roles to play, the Indian market for defibrillators has considerable potential. Medical device companies can tap into the potential of the Indian market for defibrillators.

CDSCO registration for defibrillators: A mandatory requirement

As per regulatory guidelines, CDSCO registration for defibrillators is mandatory. Defibrillators are lifesaving medical devices. Hence, the quality of these devices should be monitored and controlled. Medical devices are a vital component of the healthcare sector. Thus, regulatory guidelines are in place to ensure high quality, effective, and safe medical devices enter the Indian market. All medical devices imported, manufactured, and sold in India need CDSCO registration. Owing to the impact and demand for defibrillators, there are stringent regulations for defibrillators in India. Manufacturers aiming to enter the market for these lifesaving medical devices need to obtain CDSCO registration for defibrillators.

Benefits of the CDSCO registration for defibrillators

With the current scenario and predicted potential for growth, medical device companies will aim to focus on this product. As a lifesaving and critical device for emergency care, this device directly impacts patients’ lives. Substandard products would do more harm than good. CDSCO regulations for defibrillators in India control their quality and efficacy. The following are the benefits of CDSCO registration for defibrillators:

  • Protecting public health: CDSCO regulations for defibrillators in India are aimed at protecting public health.
  • Quality benchmark: CDCSO registered medical devices are expected to have met the quality benchmark and criteria. As proper functioning and accurate readings are vital for defibrillators, it is important the devices adhere to quality standards.
  • Regulatory compliance: CDSCO registered defibrillators indicate compliance with the Indian regulatory guidelines.
  • Access to Indian medical device market: India is a potential hub for medical devices. Thus, entering the Indian medical device market is a lucrative option for many medical device companies. To gain access to the Indian medical device market, CDSCO registration for defibrillators is mandatory.

CDSCO registration for defibrillators in India

CDSCO definition for defibrillators

CDSCO has provided a definition for these devices based on their intended used. CDSCO has defined defibrillator as a medical device that analyses the heartbeat rhythm and delivers an electrical shock to the heart for restoring the heartbeat to normal.

CDSCO class for defibrillators

To fast track the CDSCO registration process, the regulatory body has categorised medical devices into four classes. Class A, B, C, and D are the four CDSCO medical device classes. As per CDSCO guidelines, defibrillators have a medium to high level of risk. Hence, depending on the risk level and intended use, CDSCO has classified the defibrillators as Class C.

Necessary supporting documents

  • Cover letter
  • Details and address proof of the applicant
  • Power of attorney
  • TR6 challan
  • Quality assurance certificate
  • ISO 13485 certificate
  • CE design certificate
  • Free sale certificate
  • Plant master file
  • Device master file

The above list provides a basic outline of the documents required. The Pharmadocx Consultants team is ready to help you with a detailed list of documents required. Our team will also assist you in crafting these documents and help you with all your documentation needs.

Time required to obtain the registration

The approximate time required for obtaining the CDSCO registration for defibrillators is 6 to 9 months. The time required may vary. Also, the registration needs to be renewed prior to expiry.

The CDSCO registration process

The first step is usually to check whether CDSCO registration for medical devices is required for your product. Per CDSCO guidelines, defibrillators are considered notified devices and need to be registered. The registration process will be per the guidelines for Class C medical devices. In case of a foreign medical device manufacturing company, an Indian authorized agent will be required. This agent will act on behalf of the foreign company.

An overview of the registration process:

  1. Login/Signup: SUGAM is the official CDSCO online registration portal. You need to login/signup on the official portal.
  2. Form filling: The applicable form needs to be filled in correctly, per the guidelines for Class C medical devices.
  3. Documentation: The required supporting documents need to be collated. Additionally, the documents need to be arranged per CDCSO guidelines.
  4. Application: The application has to be sent online via the CDSCO online registration portal.
  5. Approval: The regulatory body officials will review the application and verify the documents submitted. Then, if the necessary criteria are fulfilled, then the regulatory body will grant the license.

Pharmadocx Consultants can make your CDSCO registration for defibrillators hassle free

CDSCO registration for defibrillators can be tricky from choosing the correct form, filling the form correctly to preparing the necessary documents. Understanding the CDSCO regulations for defibrillators in India is difficult. Pharmadocx Consultants can make the CDSCO registration process a breeze for you so that you can focus on establishing your business. Additionally, as authorized agents we can help foreign companies register their medical device business in India. Please don’t hesitate to contact us over [email protected] or 9996859227.

Let's Talk!

We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!

Phone / Whatsapp


  • Sonipat Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
  • Delhi Office - G-12, Pearls Best Heights-I, Netaji Subhash Place, Delhi, 110034

You May Also Like…


Submit a Comment

Your email address will not be published. Required fields are marked *

You cannot copy content of this page

Open chat
Contact Us!
Chat with Us on WhatsApp! We reply within 5 minutes!