21. MEDICAL DEVICES

MEDICAL DEVICES

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, which need to be registered with the CDSCO (Regulatory Body of India).

LIST OF 22 NOTIFIED MEDICAL DEVICES

• 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

1. No Renewal Requirement: Manufacturing and import licences will be valid until suspended, revoked, or surrendered.
2. Online Electronic Platform: Entire process from application submission to issue of permission/licence will be conducted online.
3. SUGAM System: Reviewing, submitting, and tracking registration documents has become easier, efficient, and transparent.
4. Established Timelines: Regulators have established timelines for majority of activities.
5. International Standards: Aids in development of quality standardisation according to international standards.
6. Easy Change Notifications: Once registration certificate is obtained, it is easy to request for change notifications.

CATEGORISATION OF MEDICAL DEVICES

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

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 sale of medical devices.
• Licences granted under Part VI for sale of drugs are presumed valid for sale of medical devices.

Supply to Hospitals against Delivery Challan

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

Recall of Medical Device

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

SUMMARY TABLE: 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)

SUMMARY TABLE: 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