The Central Drug Standard Control Organization regulates the Indian medical device Industry under the provisions of the Drugs and Cosmetics Act and Rules. Every country, like India, has its own regulatory body to look after every aspect of medical devices and drugs related services. The CDSCO looks after the regulation and sales of notified medical devices in India, which regulates and governs the CDSCO. The Directorate General of Health Services comes under the Ministry of Health and Family Welfare, under the government of India. As Per the issued notification in the Medical Device Rules 2017, the CDSCO Medical Device Registration for BP Monitor is mandatory before being marketed in India.
About BP Monitor Medical Device
A Blood Pressure (BP) monitoring device is used to precisely check a person’s blood pressure. It comprises a pump, an air pressure sensor, and an inflatable cuff. A controlled collapse and release of the artery beneath the cuff occur when the cuff is applied to the user’s left arm. It is used to measure the amount of blood the heart pumps. Numerous inexpensive, lightweight, and portable blood pressure monitors have been introduced to the market. They have an extensive reading display and are simple to operate. These digital gadgets also can save a large number of earlier readings, which helps the users maintain track of their average blood pressure. The market for Blood pressure monitors is expected to reach around 2.1 Billion US $in the year 2022, globally. The rise of chronic diseases is the driving factor which increases the market growth of BP monitor medical devices, and the government has mandated the CDSCO Medical Device Registration for BP Monitor.
Medical Device Status in India
According to a notification issued by CDSCO, four new medical devices- BP monitor, Nebuliser, Digital Thermometer, and Glucometer- are also considered drugs in India. The Central Drug Standard Control Organization regulates all the drugs and medical devices in India. The CDSCO published a notification stating the regulation of specific medical devices as drugs from January 1st, 2021. In the light of the notification number 648(E) published in the official gazette of India by the Directorate General of Health Services, the following medical devices are considered as Drug from April 1st 2020-
“All the devices that are Instrument, appliance, implant, apparatus, or any other tool, which is used either separately or in combination with other device, accessory or software 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 or 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 the anatomy
- Life support and sustaining
- Medical Device disinfection
- Conception control
Risk-Based Classification of Medical Devices
BP monitor machine is a device used to measure diastolic and systolic blood pressures. It is classified as a Class B medical device because of its Low to Medium level risk associated with the device.
According to CDSCO, medical devices are classified into four classes based on the risk involved with their usage. The DCGI or the head of CDSCO regulates all the classes of medical devices. However, licenses for Class A and Class B medical devices are obtained from State Licensing Authority. In contrast, permits for Class C and Class D medical devices are obtained from Central Licensing Authority or CDSCO. The government has also mandated the CDSCO Medical Device Registration for BP Monitor.
The following table lists the medical devices as per the risk involved with them-
|Medical Device Category||Risk Involved|
|Class-A||Low risk involved|
|Class-B||Low-Medium risk involved|
|Class-C||Medium-High risk involved|
|Class-D||High risk involved|
The degree of risk increases with the increased class level of devices. Because of the Low-Medium risk involved, the BP monitor is categorized as Class-B medical device. Hence, any kind of license for BP monitor is to be obtained by the State Licensing Authority of India.
Checklist for CDSCO Medical Device Registration for BP Monitor
Following is the checklist for CDSCO Medical Device Registration for BP Monitor:
- Application Form
- ISO 13485 Certificate
- TR6 Challan
- Power of attorney
- Undertaking that only authentic details are provided
- Full quality assurance certificate
- CE Design certificate
- Declaration of conformity
- Schedule D(I)
- Device master file
- Plant master report
- Free sale certificate
Procedure for CDSCO Medical Device Registration for BP Monitor
Before 2006, Medical Devices in India were sold in the market without any regulations, and there were no rules governing them. Later, CDSCO made a rule that all the medical devices circulated in the market must comply with CDSCO. The compliances made it compulsory for Medical Devices to be registered with CDSCO before manufacturing, selling or importing into the Indian market. Following are the steps to be followed for CDSCO Medical Device Registration for BP monitor in India-
- Determine whether the Medical Devices require registration: Firstly, the applicant must check whether the Medical Devices and IVDs list to check whether the medical device is notified or not. All the medical devices that are notified must obtain registration before they are marketed in India. In this case, the BP monitor machine 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 based on the risks involved with them. The BP Monitor falls in Class B of risk-based categorization of Medical Devices because they involve Medium level risk.
- Appointment of Indian Authorized Agent: An IAA or Indian Authorized Agent has been appointed in case the manufacturer is not an Indian. The IAA is the legal representative of the manufacturer and performs all its official duties in India.
- Documentation Process: All the necessary documents are required to be submitted to the respective authorities to get a registration license.
- Receiving of Registration and License: After submitting all the necessary documents to the correct authorities, the registration license is obtained by the manufacturer.
Timeline for CDSCO Medical Device Registration for BP Monitor
Time taken to complete the CDSCO Medical Device Registration for BP Monitor is six to nine months after completing the application. The validity of registration remains valid for three years. In case the registration needs to be renewed, the application for renewal must be submitted six months from the expiry date.
The market for Blood pressure monitors is expected to reach around 2.1 Billion US$ in the year 2022, globally. The blood pressure monitor market is, however, restrained by the high cost of advanced devices. However, there has been significant market growth in medical devices. Since BP Monitor falls in the category of Class-B Medical devices, and the registration becomes valid. Even an error in the registration process may lead to the rejection of the application. Hence, it is always advisable to get professional help for CDSCO Medical Device for BP Monitor registration.
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