The Central Drug Standard Control Organization (CDSCO)[1], which serves as India’s National Regulatory Authority (NRA), oversees all the medical devices sold in the country. The Drug Controller General of India (DCGI) is in charge of CDSCO. The Directorate General of Health Services, under the Ministry of Health and Family Welfare, is in charge of CDSCO. The Drugs and Cosmetics Act governs the approval of drugs, establishes their standards, verifies the quality control of imported drugs, conducts clinical trials, etc. supervises all the medical devices in India. The Ministry of Consumer Affairs had made a proposal to mandate the CDSCO Medical Device Registration for Nebuliser under Medical Device Rules, 2017, along with other standards set by the Bureau of Indian Standards. With effect from January 1 2021, All the Nebulisers fall under the category of mandatory Registration of CDSCO Medical Devices.
Medical Device Regulation in India
In India, the market for medical devices is a significant and vital component of the healthcare industry, especially for the purpose of preventing, diagnosing, treating, and managing severe ailments, impairments, diseases, and illnesses. It is an important component of the healthcare system and aids in carrying out important functions laid down by the National Health Policy (NHP), 2017. It is also essential for providing high-quality, affordable, and all-inclusive healthcare services in India.
According to Notification 648 (E) issued by the Directorate General of Health Services and published in The Official Gazette of India, It was announced that starting from April 1, 2020, the following medical devices would be classified as drugs:
“All the devices that are Instrument, appliance, apparatus, material, implant or any other tool, which is used either separately/in combination with other devices, software or accessory and Is used specifically for humans and animals, which do not achieve the primary intended action in or on animal or human body by any pharmacological or Immunological or metabolic means, but which may help in its intended function by such means for one/more specific purpose of-”
- Diagnosis, monitoring, prevention, alleviation or treatment of any disorder or disease
- Diagnosis, monitoring, treatment or alleviation of any disability or Injury
- Replacement, investigation, support or modification of a physiological process or of the anatomy
- Life support and sustaining
- Medical Device disinfection
- Conception control
A nebuliser is a medical device that helps you to breathe in medicine as a fine mist through a mask or a mouthpiece. CDSCO Medical Device Registration for nebulisers is mandatory as per MDR, 2017.
Types of Nebuliser
A Nebuliser is a Class C medical device used for the purpose of inhaling medication for respiratory disorders. The device delivers the medicine into the respiratory system and helps in stabilising breath and related issues. It is usually prescribed for the treatment of chronic pulmonary obstructive disease. The nebulisers are of the following types-
- Gas Nebuliser
- Heated Nebuliser
- Venturi Nebuliser
- Ultrasonic Nebuliser
- Refillable Nebuliser
Risk-wise Classification of Medical Devices
The Nebuliser is classified as a Class C medical device as per the Risk-based classification of the Medical Device Rules, 2017. There are different classifications of medical devices according to the level of risk involved with them. The DCGI regulates and controls medical devices as per medical device rules, 2017. The risk-wise classification is divided into Class A medical devices, Class B medical devices, Class C medical devices and Class D medical devices. The level of risk increases from Class A to Class D. The risk-wise classification of medical devices is listed below-
| Device Class | Risk Involved |
| Class A | Low level risk |
| Class B | Low-moderate level risk |
| Class C | Moderate-High level risk |
| Class D | High level risk |
Necessary Documents for CDSCO Medical Device Registration for Nebuliser
The documents required for registration of Nebuliser as a CDSCO medical device are-
- Application form (Form 40)
- TR6 Challan
- ISO 13485 Certificate
- Power of attorney
- The undertaking of authentic details
- CE design certificate
- Full quality assurance certificate
- Declaration of conformity
- Schedule D(I)
- Device Master File
- Plant Master File
- Free Sale Certificate
Procedure for CDSCO Medical Device Registration for Nebuliser in India
Medical devices were not regulated by any authority in India earlier. They were sold in the Indian market without any regulation. After the year 2006, the government made a rule that medical devices are required to be in compliance with the rules of CDSCO. The compliances needed mandatory requirement of registration of medical devices with CDSCO before entering the market in India. The process of CDSCO Medical Device Registration for Nebuliser is as follows-
- Determine whether the Medical Devices require registration or not: The first step is to check with the Medical Devices and IVDs list to check if the medical device is notified or not. All the notified medical devices are required to obtain registration before they are marketed in India. In this case, the Nebuliser falls under the category of notified devices and must be registered with CDSCO.
- Risk-Based Classification of Medical Devices: The notified devices which are required to be registered with CDSCO are then identified on the basis of risks involved with them. The Nebuliser fall in Class C of risk-based categorisation of Medical Devices because they involve Medium-High level risk.
- Appointment of Indian Authorized Agent (IAA): An Indian Authorized Agent has been appointed in case the manufacturer is not an Indian. The IAA acts as a representative on behalf of the manufacturer to conduct all his official duties in India.
- Technical Documentation: All the necessary documents are required to be submitted to the respective authorities in order to obtain a registration license.
- Obtain Registration and License: After all the necessary documents are submitted to the correct authorities, the registration license is obtained by the manufacturer.
Timeline for CDSCO Medical Device Registration for Nebuliser
The time period of CDSCO Medical Device Registration for Nebuliser is 6 to 9 months after completing the application. The registration validity of the Medical Device is three years. In order to renew the registration, the renewal application is required to be submitted before six months of expiry.
Conclusion
The nebuliser market In India comprises pneumatic nebulisers, ultra-sonic Nebuliser, mesh nebulisers, and nebuliser kits. By the end of 2023, the market of nebulisers in India is expected to reach INR. 703.4 million. Advanced technologies and the introduction of new products are the main reason for the market growth of medical devices in India. Since Nebulisers fall in the category of Class-C Medical devices, there is a mandatory requirement for registration. However, the slightest error in the registration process may cause the rejection of the application. Therefore, it is always advisable to get professional help for the purpose of CDSCO Medical Device Registration for Nebuliser.
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