Today devices are widely used in all branches of medicine, surgery, and community care.Medical development in terms of drugs and devices has brought about a robust change in the life of people (as offered by cosmetic treatment, dentists, face and cardiology devices).A medical device is classified in accordance with Schedule M-III, which gives it a unique classification apart from the category of drugs. FitBits and smartwatches are already widely accepted due to the integration of wearable fitness technology into society, and the market for these devices is only expected to expand in the near future. In this blog, we will discuss more Wearable Medical Devices.
With the increasing demand for consumers to monitor their health and keep track of their vital signs, the use of wearable technology has more than tripled in the last four years. According to the studies, more than 80% of consumers are willing to wear fitness technology.
Understanding the regulatory reforms imminent in India will be crucial for foreign companies and manufacturers looking to enter or expand their business in medical markets. This article highlights current regulations pertaining to applications for wearable medical device registration and certification.
What are Wearable Medical Devices?
Electronic devices that consumers may wear, like Fitbits and smartwatches, and which are made to collect information on users’ individual health and exercise habits, are referred to as wearable medical devices in the healthcare industry. These gadgets can even transmit a user’s medical data to a physician or other healthcare expert in real-time.
Some of the simplest and most original forms of wearable technology, or wearable fitness trackers, are:
- Wristbands: They are equipped with sensors to keep track of user’s physical activities and heart rate. They also provide wearers with health and fitness recommendations by syncing to various smartphone apps.
- Wearable ECG monitors: They are on the cutting edge of wearable medical devices, and what sets these monitors apart from some smartwatches is their ability to measure electrocardiograms or ECGs. The Move ECG has the ability to measure an electrocardiogram, identify atrial fibrillation, and transmit the reading to the user’s physician. Furthermore, it has automated tracking for walking, running, swimming, and bicycling. It can also measure pace, distance, and elevation.
- Wearable Blood Pressure Monitors: Wearable blood pressure monitors use technology that is linked to the user’s body to continuously check blood pressure, even while they are sleeping, exercising, or doing other things. An app is used to store and evaluate the data.
- Biosensors: They are emerging wearable medical devices that differ significantly from smartwatches and wrist trackers. The self-adhesive patch of the biosensor allows patients to roam around while gathering information on their temperature, heart rate, respiration rate, and activity.
Examples of medical wearable start-ups:
- Proteus digital health
- ten3T Healthcare
- ActoFit wearables
Benefits of Wearable Medical Devices
Wearable technology has several advantages for the user, making them one of the most popular technologies for preserving health and wellness in modern society. We have analysed some of the benefits associated with wearable which are as follows:
- Way to Achieve Good Healthcare
- Mobility and Versatility
- Ideal Option for Chronic Diseases
In addition to being used for personal health, these devices are also used as secondary diagnostic tools for the management and prevention of illnesses and chronic conditions like obesity, panic disorders, posttraumatic stress disorders, asthma, depression, Parkinson’s disease, and sleep apnea.
Challenges Associated with Wearable Medical Devices
Wearables and medical devices pose a risk that can harm the person physically and psychologically. We have analysed some of the risks associated with wearable which are as follows:
- Cyber Risks
- Technical Issues
- Regulatory Issues
- Digital Divide
- Technology Errors
In addition to these concerns, wearable technology is frequently linked to health problems like cancer because of the radiation it emits when in direct contact with the skin or in close proximity to key organs for a prolonged period of time. Other health problems cited in connection with wearable technology, aside from cancer, include headaches, nausea, and a host of other symptoms. However, to acquire a comprehensive picture, more thorough study and studies are needed because these claims lack specific data.
India’s Medical Device Quality Regulation
The Drugs and Cosmetics Act of 1940 governs the quality and safety requirements for medical devices in India (DCA). The DCA only applies to medical devices that are occasionally classified as “drugs” by the government (often referred to as “notified medical devices”).
The Medical Devices Rules of 2017 (MDR) were established in accordance with the Drugs and Cosmetics Act. These regulations develop stringent quality standards for manufacturers, importers, producers, and sellers of notified medical devices.
The Drugs & Cosmetics Act of 1940 and the Medical Devices Rules of 2017 are in charge of enforcing a mandatory licence requirement to ensure the quality and the safety of medical devices at all stages of the supply chain; as a result, all importers, producers, and sellers of wearable medical devices must get a licence from the relevant licencing body before engaging in any commerce.
A licence is only granted following quality assessments with that the licence holder’s place of business is inspected on a regular basis. Additionally, a licence holder is required to keep thorough records of all sales and purchases made in connection with notified medical devices and to ensure traceability in the event of a quality- or safety-related concern.
What is Medical Devices (Amendment) Rules, 2020?
On April 1, 2020, the Indian law governing the quality and safety of medical devices was amended, and the status of a medical device was expanded beyond the 23 previously notified medical devices, mandating that all medical devices be registered under The Drugs & Cosmetics Act of 1940.
The consequence of the amendment in law is as follows:
- Before October 1, 2021, all currently unregulated medical devices will have to be registered by the importers/manufacturers with the Drugs Controller General of India (DGCI). However, those medical devices which are regulated/have been notified to be regulated are exempted from the requirement of registration.
- Before October 1, 2022, importers or the manufacturers of presently unregulated Class A (low-risk) & Class B (low-medium risk) medical devices sold in India will have to compulsorily obtain a license.
- Before October 1, 2023, importers and the manufacturers of presently unregulated Class C (medium-high risk) & Class D (high risk) medical devices sold in India will have to mandatorily obtain a license.
Medical device importers and manufacturers must acquire ISO-13485 compliance certification in order to register their products.
What are the Requirement for Registration Wearable Medical Devices?
The manufacturers or importers of wearable medical devices must compulsorily register their medical devices with the Drugs Controller General of India (DCGI). If an importer or a manufacturer is unable to obtain registration for its wearable medical device, then they will not be able to market and sell their medical device in India until a registration number is obtained. The Drugs Controller General of India will start accepting applications for registration through a dedicated online portal called “Online System for Medical Devices”. There is no time frame prescribed as of now for processing the application for registration by DCGI. It the registration will be done instantly after the submission of all information and documents on the online portal.
The registration process is relatively more straightforward. Any importer or manufacturer of wearable medical devices will be able to obtain registration on the submission of the following information:
- Name of the company/firm/any other entity
- Name & address of manufacturing site (for devices manufactured in India only)
- Specification & standards of medical device (for imported devices only)
- Details of medical devices (which icludes: Generic Name, Model No., Intended Use, Class of Medical Device, Material of Construction, Dimensions (if applicable), Shelf Life, Sterile/Non-sterile status, Brand name or Trademark only if registered under India’s trade mark law)
- Certificate of compliance concerning ISO 13485 standard accredited by NABCB or National Accreditation Board for Certification Bodies/International Accreditation Forum (IAF) in respect of such medical device
- Free Sale Certificate (FSC) from country of origin (for imported devices only)
- A duly-signed undertaking stating that the information furnished by the applicant is true and authentic
- The registration will be completed only upon the generation of a registration number.
What are the ramifications of not registering a wearable medical device?
If an importer or manufacturer of a wearable medical device fails to get a registration, the importer or manufacturer must stop importing or manufacturing the medical device until the registration is obtained.
The DCGI or State-level Licensing Authority will be able to quickly determine whether a medical device is manufactured or imported without registration. According to the Legal Metrology (Packaged Commodities) Rules, 2011, every manufacturer and importer of a medical device (whether regulated or unregulated) must indicate the date of manufacturing or date of import on the device’s label. Therefore, if a medical device has a declaration on its label stating that it was imported or manufactured on or after October 1, 2021, but the label lacks a DCGI registration number, DCGI or the appropriate State-level Licensing Authorities will confiscate the medical device and take appropriate legal action against the importer or manufacturer. Any MDR infraction, including failing to register or receive a licence before the deadline, may result in criminal charges, which include imprisonment and a fine. Any stock of hospital devices that is sold without registration or authorisation risked being seized as well.
A wearable medical device is characterised as a device that is autonomous, non-invasive, and that carries out a specific medical function, such as monitoring or support, for an extended period of time. As implied by the word “wearable,” the device is either supported by the user’s body or their clothing. This decade has seen a tremendous increase in the usage of wearable medical equipment, classified into three forms: wearable monitoring devices, wearable rehabilitation devices, and wearable medical aids. Medical devices have significantly improved health and quality of life by enhancing physicians’ capacity to identify and treat diseases. Despite the global economic slowdown, the Indian medical device business is expanding at a rapid pace. Wearable medical gadgets are intended to help patients with temporary or permanent disabilities in the long run. Numerous vital indicators, including the electrocardiogram (ECG), respiration, skin temperature, pulse, blood pressure, body kinematics, etc., can be continuously monitored by patients.
Read Our Article: CDSCO Medical Device Registration For Defibrillators – An Overview