• Manoj Swaminathan

Categorizing Medical Devices - Asymmetry still Exists!

Updated: Sep 12

Whenever we talk about harmonization of Pharmacovigilance regulations for medicinal products, the first thing that comes to our minds is ICH, which is the International Council of Harmonization.


Similarly, for medical devices, we have the IMDRF or the International Medical Device Regulators Forum


The Global Harmonization Task Force (GHTF) was founded in 1993 by the governments and industry representatives from Australia, Canada, Japan, European Union, and the United States. The purpose of the GHTF is to encourage convergence in standards and regulatory practices related to safety, performance, and quality of medical devices.


GHTF's Mission was to harmonize the implementation of medical device regulations across the globe. Its mission has now been taken over by the International Medical Device Regulators Forum (IMDRF), a successor organization composed of officials from regulatory agencies



United States


The FDA categorizes medical devices into three classes –

Class I

Class II, and

Class III Medical Devices


These are based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.


Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) were signed into law, on 28th May 1976.


Pre-amendments Devices in the United States A pre-amendment device is one that was in commercial distribution before 28th May 1976. These devices were initially classified as Class I, II, or III.


Post Amendments Devices in the United States

Devices that were not available on the market before 28th May 1976 are generally referred to as post amendments devices. These are automatically classified into Class III, regardless of the risk they pose.


Canada


Like in United States, the medical devices are categorized or classified into Class I, II and III.


India


Medical devices under Medical Devices Rules, 2017, are classified as per the Global Harmonization Task Force (GHTF) based on associated risks, into


Class A (low risk)

Class B (low-moderate risk)

Class C (moderate-high risk)


EU/EEA and Australia


In EU/EEA and Australia, the medical devices are categorized into the following:


Class I Medical Devices

Class IIa Medical Devices

Class IIb Medical Devices

Class III Medical Devices

Japan


In Japan, medical devices are categorized into the following:


Class I Medical Devices

Class II Medical Devices

Class III Medical Devices

Class IV Medical Devices



In the US, EU, Australia and Canada, the artificial cardiac valves, pacemakers, and stent-grafts are categorized as Class III medical devices, while in India these are categorized as Class C. In Japan, these medical devices are considered in Class IV category.



Although the IMDRF exists, one can still appreciate the asymmetry in categorization across countries. Further harmonization will certainly help!



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