MEDICAL DEVICES: A TEACHER’S COMPREHENSIVE GUIDE
Welcome, future pharmacists and healthcare professionals!
A medical device is any instrument, device, implement, machine, appliance, implant, in vitro reagent, software, material, or other similar or related item that the manufacturer intends to use for a medical purpose, either alone or in combination. There are 22 notified medical devices under the Drugs & Cosmetics Act, 1940, and they need to be registered with the CDSCO (the Regulatory Body of India).
As a pharmacy educator with years of experience teaching pharmaceutical sciences and regulatory affairs, I have observed that students often find medical device regulations complex and confusing. However, understanding medical devices and their regulations is essential for every healthcare professional—they play a critical role in diagnosis, treatment, and patient care. In this comprehensive guide, I will break down medical device regulations into manageable sections, explaining the classification system, the Medical Devices Rules 2017, manufacturing and sale provisions, and the categorisation parameters. Let us begin our journey.
Dpharmguru’s exam insights:
Medical Devices are frequently tested in pharmacy and healthcare exams. Remember: There are 22 notified medical devices under the Drugs & Cosmetics Act; the Medical Devices Rules 2017 were introduced to streamline regulation; devices are classified into Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk). Pay special attention to the classification parameters—these are almost always asked in exams!
NOTIFIED MEDICAL DEVICES UNDER DRUGS & COSMETICS ACT
There are 22 notified medical devices under the Drugs & Cosmetics Act, 1940 that need to be registered with the CDSCO:
- Disposable Hypodermic Syringes
- Disposable Hypodermic Needles
- Disposable Perfusion Sets
- In vitro Diagnostic Devices for HIV, HbsAg and HCV
- Cardiac Stents
- Drug Eluting Stents
- Catheters
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopaedic Implants
- Internal Prosthetic Replacements
- Ablation Device
Dpharmguru’s exam insights:
The 22 notified medical devices are frequently tested. Remember the key ones: Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, Heart Valves, and Orthopaedic Implants. These are the most commonly asked in exams!
MEDICAL DEVICES RULES, 2017 — KEY FEATURES
The Medical Devices Rules, 2017 introduced several key features for regulatory approvals and registrations:
- No Regular Renewals: For the first time, there will be no need to renew licences or registrations on a regular basis. Manufacturing and import licences will be valid until they are suspended, revoked, or surrendered.
- Online Platform: The entire process will be conducted through an online electronic platform, beginning from submission of an application and ending with the issue of permission/licence.
- SUGAM System: With the SUGAM system, reviewing, submitting, and tracking registration documents has become considerably easier, efficient, and transparent.
- Timelines: The regulators have established timelines for the majority of activities.
- Quality Standardisation: The new Medical Devices Rules, 2017 will aid in the development of quality standardisation in framework regulations according to international standards.
- Change Notifications: Once the registration certificate has been obtained, it is easy to request change notifications.
Dpharmguru’s exam insights:
The Medical Devices Rules, 2017 are frequently tested. Remember: No regular renewals; online platform (SUGAM); established timelines; international quality standards. The SUGAM system is a key feature that makes the process more efficient and transparent!
CATEGORISATION OF MEDICAL DEVICES
Medical device classification in India is based on risk level:
| Class | Risk Level | Device Examples |
|---|---|---|
| A | Low Risk | Thermometers, tongue depressors |
| B | Low-Moderate Risk | Hypodermic needles, suction devices |
| C | Moderate-High Risk | Lung ventilators, bone fixation plates |
| D | High Risk | Heart valves, implantable defibrillators |
Dpharmguru’s exam insights:
Device classification is frequently tested. Remember: Class A (Low Risk) — Thermometers; Class B (Low-Moderate) — Hypodermic needles; Class C (Moderate-High) — Lung ventilators; Class D (High Risk) — Heart valves. The risk level determines the regulatory requirements!
PARAMETERS FOR CATEGORISATION OF MEDICAL DEVICES
a) Non-Invasive Medical Devices that Come into Contact with Injured Skin
- Class A: Used as a mechanical barrier, for compression or absorption of exudates, for wounds that have not pierced the dermis and can heal by primary intention.
- Class B: Designed to be used with wounds that have pierced the dermis or for the management of a wound’s microenvironment.
- Class C: Intended to be used for wounds that have pierced the dermis and cannot heal by primary intention.
b) Non-Invasive Medical Devices for Modifying Compositions of Substances
- Class C: Designed to modify the biological or chemical composition of blood or other body liquids.
- Class B: Intended modification is carried out by filtration, centrifuging, or any other exchange of gas or heat.
c) Invasive (Body Orifice) Medical Devices for Transient Use
- Class A: Intended to be used for a short period of time; not intended for use with an active medical device; intended to be used with a Class A medical device.
- Class B: Intended to be used on the eyeball’s external surface; likely to be absorbed by the mucous membrane.
d) Surgically Invasive Medical Devices for Transient Use
- Class B: Designed for transient use.
- Class A: Reusable surgically invasive medical device intended for transient use.
- Class C: Intended to supply energy in the form of ionising radiation; intended to have a biological effect or be entirely or mostly absorbed by the human body; intended for administration of any medicinal product via delivery system in a potentially dangerous way.
- Class D: Intended to be used in direct contact with the central nervous system or for the diagnosis, monitoring, or correction of a heart or central circulatory system defect through direct contact with these body parts.
e) Medical Devices Incorporating Medicinal Products
- Class D: If the incorporated substance may be regarded as a medicinal product and is capable of acting on a human body in a supportive manner to the medical device.
- Class B: If the incorporated substance is a medicinal product exempted from the licensing requirements of the Drugs and Cosmetics Act, 1940.
f) Medical Devices Incorporating Animal or Human Cells, Tissues or Derivatives
- Class D: If made from or contains animal or human cells, tissues, or derivatives that are rendered non-viable; or microbial or recombinant cells, tissues, or derivatives.
- Class A: If created from or includes non-viable animal tissues that come into contact with intact skin only.
g) Medical Devices for Sterilisation or Disinfection
- Class C: Intended for sterilization of any other medical device; end-point disinfection; contact lens disinfection, cleaning, rinsing, or hydration.
- Class B: Designed for the disinfection of any other medical device before it is sterilised or undergoes end-point disinfection.
h) Medical Devices for Contraceptive Use
- Class C: Designed for contraception or prevention of transmission of any STD.
- Class D: An implantable or invasive medical device intended for long-term use.
Dpharmguru’s exam insights:
The categorisation parameters are frequently tested. Remember: Non-invasive devices for injured skin are Class A/B/C depending on wound depth; surgically invasive devices for transient use range from Class A to D; devices incorporating medicinal products are Class D; devices with animal/human cells are Class D; sterilisation devices are Class C; contraceptive devices are Class C/D. These detailed parameters are often asked in exam questions!
BASIC ASPECTS RELATED TO MANUFACTURE
The Medical Device Rules (MDR), 2017 is India’s primary legislation governing medical device approval, production, import, and sale. MDR is a set of rules enacted under India’s major drug and medical device control legislation, the Drugs and Cosmetics Act, 1940. The CDSCO enforces the D&C Act (including the MDR) at the central level, and the State Licensing Authorities (SLAs) enforce it at the state level.
Application for Manufacture of Class A or Class B Medical Devices
- Application to the State Licensing Authority in Form MD-3 (licence) or Form MD-4 (loan licence).
- Includes an undertaking that the requirements of the Quality Management System have been met.
- Class A: Licence granted within 45 days after scrutiny.
- Class B: Manufacturing site must meet Quality Management System requirements and be verified through an audit by a Notified Body before the licence is granted.
- Appeals: If rejected, the aggrieved person may file an appeal with the State Government within 45 days.
Application for Manufacturing Class C or Class D Devices
- Application to the Central Licensing Authority in Form MD-7 (licence) or Form MD-8 (loan licence).
- Accompanied by a fee and required documents.
- The Central Licensing Authority may use the services of any expert in the relevant field.
- Scrutiny to be completed within 45 days of online submission.
- A Notified Body may be hired to inspect the manufacturing site if necessary.
Dpharmguru’s exam insights:
Manufacturing provisions are frequently tested. Remember: Class A/B devices apply to State Licensing Authority; Class C/D devices apply to Central Licensing Authority; Form MD-3/4 for Class A/B; Form MD-7/8 for Class C/D; Class B requires a Notified Body audit; Class C/D requires scrutiny within 45 days. Appeals must be filed within 45 days!
BASIC ASPECTS RELATED TO SALE
Provisions for Sale of Medical Devices
- Part VI of the Drugs and Cosmetics Rules, 1945, related to Sale of Drugs Other Than Homeopathic Medicines, shall apply mutatis mutandis to the sale of medical devices.
- Prior to the effective date of these rules, a licence granted or renewed under Part VI for the sale of drugs is presumed to be valid for the sale of medical devices.
Supply of Medical Device to Hospitals Against Delivery Challan
- Any person with a valid licence may supply invasive medical devices to be implanted through surgical intervention to a hospital against a delivery challan.
- A cash or credit memo shall be generated for medical devices supplied and used in surgical intervention, and a record shall be kept by the licensee.
Recall of Medical Device
- The manufacturer or authorised agent shall immediately initiate procedures to remove the medical device from the market if it is likely to pose a risk to the health of a user or patient.
- The manufacturer or authorised agent shall promptly notify the competent authority and cooperate with them.
- The manufacturer, importer, or authorised agent shall notify the competent authority of the action taken to prevent risk to the patient.
Dpharmguru’s exam insights:
Sale provisions are frequently tested. Remember: Part VI of D&C Rules applies to medical device sales; existing drug sale licences are valid for medical devices; delivery challans are used for supply to hospitals; device recall procedures must be initiated immediately if there is a safety risk. The recall provisions are particularly important for patient safety!
COMPARISON: MEDICAL DEVICE CLASSES
| Feature | Class A | Class B | Class C | Class D |
|---|---|---|---|---|
| Risk Level | Low | Low-Moderate | Moderate-High | High |
| Licensing Authority | State | State | Central | Central |
| Application Form | MD-3/MD-4 | MD-3/MD-4 | MD-7/MD-8 | MD-7/MD-8 |
| Notified Body Audit | Not required | Required | May be required | May be required |
| Examples | Thermometers | Hypodermic needles | Lung ventilators | Heart valves |
FREQUENTLY ASKED QUESTIONS (FAQs)
1. What is a medical device?
A medical device is any instrument, device, implement, machine, appliance, implant, in vitro reagent, software, or material intended for a medical purpose, either alone or in combination.
2. How many medical devices are notified under the Drugs & Cosmetics Act?
There are 22 notified medical devices under the Drugs & Cosmetics Act, 1940.
3. What is the SUGAM system?
The SUGAM system is an online electronic platform introduced under the Medical Devices Rules, 2017, for submitting, reviewing, and tracking registration documents, making the process more efficient and transparent.
4. What are the four classes of medical devices in India?
Medical devices are classified into: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk).
5. What forms are used for manufacturing licences?
Form MD-3/MD-4 for Class A/B devices (State Licensing Authority); Form MD-7/MD-8 for Class C/D devices (Central Licensing Authority).
6. What is the timeline for granting a Class A device manufacturing licence?
For Class A devices, the State Licensing Authority shall grant a licence within 45 days of the date the application is made.
7. What is the appeal process if a licence application is rejected?
If an application for a licence is rejected, the aggrieved person may file an appeal with the State Government within 45 days of receiving the rejection, which may be resolved within 60 days.
8. What is the recall procedure for medical devices?
If a medical device is likely to pose a risk to health, the manufacturer shall immediately initiate recall procedures, notify the competent authority, and cooperate with them to prevent risk to patients.
SUMMARY
Medical devices are critical components of modern healthcare, ranging from simple thermometers to complex implantable defibrillators. In India, 22 medical devices are notified under the Drugs & Cosmetics Act, 1940 and are regulated by the CDSCO. The Medical Devices Rules, 2017 introduced significant reforms, including no regular renewals, an online platform (SUGAM), established timelines, and quality standardisation.
Medical devices are classified into four classes based on risk: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk). The categorisation parameters include invasiveness, duration of contact, biological effects, and incorporation of medicinal products or human/animal tissues.
Manufacturing licences for Class A/B devices are granted by the State Licensing Authority (Forms MD-3/MD-4), while Class C/D devices require approval from the Central Licensing Authority (Forms MD-7/MD-8). The sale of medical devices follows the provisions of Part VI of the Drugs and Cosmetics Rules, and devices that pose a risk to patients must be recalled immediately.
As I always tell my students: “Medical devices are not just instruments—they are life-saving tools. Understanding their regulation ensures that patients receive safe, effective, and high-quality devices. This knowledge is essential for every healthcare professional.”
REFERENCES AND FURTHER READING
- Medical Devices Rules, 2017. Ministry of Health and Family Welfare. Government of India.
- Drugs and Cosmetics Act, 1940 and Rules, 1945. Government of India.
- Central Drugs Standard Control Organization (CDSCO). (2022). Guidelines on Medical Devices. Retrieved from https://cdsco.gov.in.
- World Health Organization (WHO). (2022). Guidelines on Medical Devices. Retrieved from https://www.who.int.
- International Medical Device Regulators Forum (IMDRF). (2022). Medical Device Classification Guidelines. Retrieved from https://www.imdrf.org.
Disclaimer: This article is for educational purposes only and does not constitute legal advice. Medical device regulations and guidelines may change over time—always refer to the latest official guidelines and consult qualified professionals for specific matters.
written by:
Dr. N. Sujith Kumar
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