What are the Different classes of medical devices in India?
In the year 2017, the ministry of health and family welfare introduced new rules for Medical devices. The new rules have been created to bring the regulations at par with the Global Harmonisation Task Force (GHTF) and international practices. Initially, the government had only marked 15 devices to be regulated as drugs. This number has now been increased to 37 medical devices. The new rules have been brought in to ease the regulatory process for manufacturers in India and also to support the ease of doing business. These steps shall enhance the production of medical devices in the country and, at the same time, provide better care and safety. CDSCO is the organisation responsible for overseeing the affairs related to the classification of medical devices. In this blog, we shall look at the Different classes of medical devices and their risk levels.
Need for device quality Regulation in India
The law that governs the registration of medical devices in India is the Drugs and Cosmetics Act, 1940. However, the issue is that the act is applicable only to the “drug”. Only those medical devices categorised as drugs (a.k.a Notified medical devices) shall be under the ambit of this act. The government introduced the Medical devices rules 2017 under the drugs and cosmetics act, and the rules also created Different classes of medical devices. These rules have to be followed by the stakeholders such as importers, marketers, manufacturers and sellers.
The Drugs and Cosmetics act and Medical
devices Rules have made it mandatory for all stakeholders to have a mandatory
license before carrying out any activity related to medical devices. The
license issuance depends on stringent quality checks and periodic inspections.
The license holder is also required to maintain track of their products so that
the authorities can trace the device in case of any complaint or failure.
Impact of medical devices Registration in India
The medical device registration keeps a tab on the investigation, performance evaluation, import, manufacture and sale. CDSCO is involved in each of the steps. Therefore the level of compliance by the concerned stakeholder significantly increases. If the license holder fails to comply with norms, then his license can be revoked.
Quality Control Measures:
Medical device registration also requires the license holder to ensure that their devices pass strict quality control measures. The devices are required to follow the control norms set forth by the Bureau of Indian Standards, and in case there are no BIS norms for it, then regulations laid down the Health ministry shall be followed.
The price of all the drugs shall be regulated by the authorities. Once a medical device is registered, then it shall come under the purview of Drugs (Prices and Control Order, 2013). There might be a cap of 10% on the price of the device, or a fixed ceiling price shall be introduced.
Greater Involvement by the Ministry of Health
The ministry of health shall have a constant watch over the devices that are under the umbrella of the registration. This mechanism makes it easier for the ministry to implement standards, effectively regulate current ones, and even ban certain practices that might harm consumers.
The List of Devices under the regulations
As per the rules, the following products shall be allotted into different classes of medical devices:
|1.||Disposable Hypodermic Syringes;|
|2.||Disposable Hypodermic Needles|
|3.||Disposable Perfusion Sets|
|4.||Substances used for in vitro diagnosis including Blood Grouping Sera|
|8.||Intra Ocular Lenses|
|12.||Scalp Vein Set|
|14.||Internal Prosthetic Replacements|
|16.||Ligatures, Sutures and Staplers|
|17.||Intra Uterine Devices (Cu-T)|
|22.||Blood/Blood Component Bags|
|23.||Organ Preservative Solution|
|25.||Blood Pressure Monitoring Device|
|28.||All implantable medical devices Equipment|
|29.||CT Scan Equipment|
|35.||Bone marrow cell separator|
|36.||Disinfectants and insecticides specified in Medical Devices Rules|
Different classes of medical devices as per CDSCO
The classification of the medical devices are based on the risk the device carries. The risk here is depended upon the nature of the device and the intended use of it. Different classes of medical devices are as follows:
|1.||Class A||Low||Alcohol swabs, cotton wools and surgical dressing etc.|
|2.||Class B||Low Moderate Risk||BP monitoring device, thermometer, glucometer etc.|
|3.||Class C||Moderate-High Risk||Implants, cardiac stents. Bone cement etc.|
|4.||Class D||High Risk||The angiographic guide wire, heart valves Etc.|
The New medical policy by the CDSCO was introduced to strengthen the regulations around medical devices. The medical device registration shall ensure that the manufacturers and other stakeholders produce quality products. The regulations are a small step towards bringing Indian medical standards to par with international standards. With proper implementation, the medical device registration will be able to reduce harm which can be caused by faulty medical apparatus.
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