What are the Different classes of medical devices in India?

Different classes of medical devices
Ganesh Nair
| Updated: Sep 21, 2022 | Category: CDSCO

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[1]. 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

Mandatory Compliance:

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.

Price Control:

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:

S.no Product
1. Disposable Hypodermic Syringes;
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. Substances used for in vitro diagnosis including Blood Grouping Sera
5. Cardiac Stents
6. Drug-Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cement
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic Replacements
15. Ablation Devices
16. Ligatures, Sutures and Staplers
17. Intra Uterine Devices (Cu-T)
18. Condoms
19. Tubal Rings
20. Surgical Dressings
21. Umbilical tapes
22. Blood/Blood Component Bags
23. Organ Preservative Solution
24. Nebulizer
25. Blood Pressure Monitoring Device
26. Glucometer
27. Digital Thermometer
28. All implantable medical devices Equipment
29. CT Scan Equipment
30. MRI Equipment
31. Defibrillators
32. PET Equipment
33. X-Ray Machine
34. Dialysis Machine 
35. Bone marrow cell separator
36. Disinfectants and insecticides specified in Medical Devices Rules
37. Ultrasound equipment

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:

S.no Class Risk Type Devices
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.

Conclusion:

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.

Read our Article:Clinical Performance Evaluation for New IVD Medical Device

Spread the love
Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

 

Related Articles

CDSCO Medical Devices
| Date: Aug 27, 2022 | Category: CDSCO

Manufacturing Registration for CDSCO Medical Devices

India is one of the biggest exporters of medical devices in the world. Earlier, there were laws to regulate medical devices in India. After 2006, The medical devices circulating in...

Read More
CDSCO Dual Use NOC
| Date: Sep 23, 2022 | Category: CDSCO, Other Services

What is the CDSCO Dual Use NOC?

The drugs that are used for dual purposes are the ones that are used for pharmaceutical uses as well as raw materials in other industries. Such drugs which serve the...

Read More
CDSCO Sugam
| Date: Jun 28, 2022 | Category: CDSCO

CDSCO Sugam: An Overview

The Central Drug Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India are the National Regulatory Authority (NRA)...

Read More

ARTICLES

Hi! My name is Akanksha! Let's talk.