21. Medical Devices: A Complete Guide to Regulations, Classification, and Licensing in India

MEDICAL DEVICES: A TEACHER’S COMPREHENSIVE GUIDE TO REGULATIONS, CLASSIFICATION, AND LICENSING UNDER DRUGS AND COSMETICS ACT

Welcome, future pharmacists and healthcare professionals!

As a pharmacy law and ethics educator with years of experience teaching pharmaceutical regulations, I have observed that medical devices are an increasingly important area of healthcare regulation. 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. Under the Drugs and Cosmetics Act, 1940, there are 22 notified medical devices that need to be registered with the Central Drugs Standard Control Organization (CDSCO), the regulatory body of India.

In this comprehensive guide, I will take you through the list of 22 notified medical devices, the key features of the New Medical Devices Rules India, 2017, the categorization of medical devices based on risk, the parameters for classification, and the basic aspects related to manufacture and sale of medical devices. By the end of this article, you will have a thorough understanding of the regulatory framework governing medical devices in India. Let us begin.

LIST OF 22 NOTIFIED MEDICAL DEVICES UNDER DRUGS AND COSMETICS ACT, 1940

The following 22 medical devices are notified under the Drugs and Cosmetics Act, 1940, and require registration 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
• Ligatures
• Sutures and Staplers
• Condoms
• Blood Grouping Serums
• Specified Kits for Blood Grouping
• Radiation Therapy Equipment
• Diagnostic Nuclear Medicine Equipment

NEW MEDICAL DEVICES RULES INDIA, 2017 – KEY FEATURES

The New Medical Devices Rules, 2017, brought significant changes to the regulation of medical devices in India. The key features include:

1. No Renewal Requirement: Manufacturing and import licences will be valid until suspended, revoked, or surrendered. This reduces the administrative burden on manufacturers.
2. Online Electronic Platform: The entire process from application submission to issue of permission/licence will be conducted online, enhancing transparency and efficiency.
3. SUGAM System: Reviewing, submitting, and tracking registration documents has become easier, efficient, and transparent through the SUGAM online portal.
4. Established Timelines: Regulators have established timelines for majority of activities, ensuring timely processing of applications.
5. International Standards: The rules aid in the development of quality standardization according to international standards, aligning Indian regulations with global practices.
6. Easy Change Notifications: Once a registration certificate is obtained, it is easy to request for change notifications, facilitating updates to product information.

CATEGORISATION OF MEDICAL DEVICES

Medical devices are categorized based on the risk they pose to patients and users. The classification system uses four classes:

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

PARAMETERS FOR CATEGORISATION OF MEDICAL DEVICES

The categorization of medical devices is based on several parameters, including the nature of the device, its duration of use, and its interaction with the body.

Non-invasive Medical Devices (Injured Skin)

• Class A: Mechanical barrier, compression or absorption of exudates for wounds not piercing dermis.
• Class B: Wounds that have pierced dermis or for management of wound’s microenvironment.
• Class C: Wounds that have pierced dermis and cannot heal by primary intention.

Non-invasive Devices (Modifying Compositions)

• Class C: Modifies biological/chemical composition of blood or other body liquids.
• Class B: Modification by filtration, centrifuging, or exchange of gas or heat.

Invasive (Body Orifice) Devices – Transient Use

• Class A: Short period use, not with active medical device, or used with Class A device.
• Class B: Use on eyeball’s external surface or likely to be absorbed by mucous membrane.

Surgically Invasive Devices – Transient Use

• Class B: Designed for transient use.
• Class A: Reusable surgically invasive device for transient use.
• Class C: Supplies ionising radiation; has biological effect/mostly absorbed; dangerous drug administration.
• Class D: Direct contact with CNS or for heart/central circulatory system defect.

Medical Devices Incorporating Medicinal Products

• Class D: Contains substance that may be regarded as medicinal product.
• Class B: Contains substance exempted from licensing requirements of D&C Act.

Devices Incorporating Animal/Human Cells, Tissues or Derivatives

• Class D: Made from or contains animal/human cells, tissues, or derivatives; microbial or recombinant cells.
• Class A: Non-viable animal tissues that come into contact with intact skin only.

Medical Devices for Sterilisation or Disinfection

• Class C: Sterilisation or end-point disinfection of other devices; contact lens disinfection.
• Class B: Disinfection before sterilisation or end-point disinfection.

Medical Devices for Contraceptive Use

• Class C: Designed for contraception or prevention of STD transmission.
• Class D: Implantable or invasive device intended for long-term use.

BASIC ASPECTS RELATED TO MANUFACTURE

Application for Manufacture of Class A or Class B Medical Device

• Apply to State Licensing Authority in Form MD-3 (licence) or Form MD-4 (loan licence).
• Includes undertaking that Quality Management System requirements have been met.
• Class A: Licence granted in Form MD-5 or MD-6 within 45 days.
• Class B: Manufacturing site must meet QMS and applicable standards; audit by Notified Body within 90 days; licence granted within 20 days of receiving audit report.
• Appeal to State Government within 45 days of rejection.

Application for Manufacture of Class C or Class D Devices

• Apply to Central Licensing Authority in Form MD-7 (licence) or Form MD-8 (loan licence).
• Central Licensing Authority may use expert services.
• Scrutiny completed within 45 days of online submission.
• Inspection by team of officers with specialists as required.
• Notified Body may be hired to inspect manufacturing site.

BASIC ASPECTS RELATED TO SALE

Provisions for Sale of Medical Devices

• Part VI of Drugs and Cosmetics Rules, 1945 (Sale of Drugs Other Than Homeopathic Medicines) applies mutatis mutandis to the sale of medical devices.
• Licences granted under Part VI for the sale of drugs are presumed valid for the sale of medical devices.

Supply to Hospitals against Delivery Challan

• Licensed persons may supply invasive medical devices to hospitals against a delivery challan.
• A cash/credit memo shall be generated, and a record shall be kept by the licensee.

Recall of Medical Device

• The manufacturer/authorised agent must initiate procedures to remove unsafe medical devices from the market and from patients.
• Promptly notify the competent authority and cooperate.
• Shall not prevent or discourage any person from cooperating with competent authorities.

SUMMARY TABLES

Table 1: Medical Device Classification

Class	Risk Level	Regulatory Authority	Application Form
A	Low Risk	State Licensing Authority	MD-3 (licence) / MD-4 (loan)
B	Low-Moderate Risk	State Licensing Authority	MD-3 (licence) / MD-4 (loan)
C	Moderate-High Risk	Central Licensing Authority	MD-7 (licence) / MD-8 (loan)
D	High Risk	Central Licensing Authority	MD-7 (licence) / MD-8 (loan)

Table 2: Forms Used in Medical Devices Regulation

Form No.	Purpose
MD-3	Application for licence to manufacture Class A/B medical device
MD-4	Application for loan licence to manufacture Class A/B medical device
MD-5	Licence to manufacture Class A medical device
MD-6	Loan licence to manufacture Class A medical device
MD-7	Application for licence to manufacture Class C/D medical device
MD-8	Application for loan licence to manufacture Class C/D medical device

A TEACHER’S LEGAL INSIGHTS

Over my years of teaching pharmacy law and ethics, I have developed a few key insights about medical devices regulation that I always share with my students:

• Medical devices are increasingly regulated like drugs in India. Understanding the classification and licensing requirements is essential for pharmacy professionals.
• The New Medical Devices Rules, 2017, have significantly simplified the regulatory process through online platforms and fixed timelines.
• The categorization of devices based on risk (Classes A to D) is crucial for determining the appropriate regulatory pathway and licensing authority.
• Pharmacists must be aware of the recall procedures for medical devices to ensure patient safety and regulatory compliance.

FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is a medical device under the Drugs and Cosmetics Act?

A medical device is any instrument, device, implement, machine, appliance, implant, in vitro reagent, software, material, or other similar or related item intended for a medical purpose, either alone or in combination.

2. How many medical devices are notified under the Drugs and Cosmetics Act?

There are 22 notified medical devices under the Drugs and Cosmetics Act, 1940, which need to be registered with the CDSCO.

3. What are the key features of the New Medical Devices Rules, 2017?

The key features include no renewal requirement, online electronic platform (SUGAM system), established timelines, alignment with international standards, and easy change notifications.

4. How are medical devices classified?

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).

5. What is the application form for manufacturing Class A medical devices?

Form MD-3 is used for the licence, and Form MD-4 is used for the loan licence to manufacture Class A medical devices.

6. What is the application form for manufacturing Class C medical devices?

Form MD-7 is used for the licence, and Form MD-8 is used for the loan licence to manufacture Class C medical devices.

7. What is the recall procedure for medical devices?

The manufacturer or authorised agent must initiate procedures to remove unsafe medical devices from the market, promptly notify the competent authority, and cooperate with regulatory bodies.

SUMMARY

Medical devices are an essential part of modern healthcare, and their regulation under the Drugs and Cosmetics Act, 1940, ensures their safety, efficacy, and quality. The New Medical Devices Rules, 2017, have streamlined the regulatory process through online platforms, fixed timelines, and risk-based classification. Understanding the classification, licensing requirements, and sale provisions for medical devices is essential for pharmacy professionals.

As healthcare professionals, we have a responsibility to ensure that medical devices are used safely and effectively, and that regulatory compliance is maintained.

As I always tell my students: “Medical devices are not just equipment—they are life-saving tools. Understanding their regulation is essential for ensuring patient safety.”

REFERENCES AND FURTHER READING

• Drugs and Cosmetics Act, 1940 and Rules, 1945. Government of India.
• New Medical Devices Rules, 2017. Central Drugs Standard Control Organization (CDSCO).
• Central Drugs Standard Control Organization (CDSCO). (2022). Medical Devices Regulations. Retrieved from https://cdsco.gov.in.
• Ministry of Health and Family Welfare. (2021). Gazette Notification on Medical Devices. Government of India.

Disclaimer: This article is for educational purposes only and does not constitute legal advice. Always refer to the latest regulatory guidelines and consult legal experts for compliance matters.