Global medical device regulations

Global medical

device

regulations

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Global medical device

regulations

Medical devices make a huge market with a steady growth

rate. It is predicted that the medical devices market will touch

$400 billion in 2017, from its volume in the roundabouts of

$320 billion in 2012. This means that the industry is growing at

a healthy rate. Regulation in this industry, which has always

been necessary and very stringent, will continue to be a

driving force for the industry in the years to come, with the

high numbers of medical devices entering the market year

after year and with their use likely to be directed at the

geriatric population.

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The expansion and growth of the medical devices market

have made regulation both important and challenging. The

sheer variety and number of medical devices is a major

reason for this, because anything from a tongue depressor

to devices that use sophisticated software technology to

measure vital parameters or carry out surgeries are part of

medical devices.

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No getting away from

regulationYet, regulation is extremely important, for the core reason that it

should bring about safety among the users of medical devices.

Any medical device should primarily aid in bringing about an

improvement in the quality of healthcare and the quality of life

of the patient and a reduction of the use of products that do not

guaranteed these.

Global regulation for medical devices seeks to bring about an

improvement in the development and use of diagnostics, as

well, as a tool for ensuring good health globally. Global medical

device regulations aim to reduce adverse events associated

with the use of medical devices, although the definition of the

event itself could vary and at improving the effectiveness of the

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Regulation should aim to

bring about harmonizationRegulations are important to also bring about harmonization and

standardization in a number of processes and parameters in the

industry. For this reason, the world health organization and other

bodies have been at the forefront of making regulations that are of

a global nature. No matter how benign this intention, the WHO

itself admits that no regulation can bring in an absolutely safe

product.

Yet, there have been consistent efforts to bring about regulation at

some level, so that there is an element of conformity with a few

standards at the global level. The WHO carries out meeting at

different locations and at different times to discuss with member

states the ways of strengthening the regulatory framework and

working ways of implementing these globally in a uniform manner.

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Regulations from the WHO are not just global in their

application; they are also comprehensive in that they are for all

types of devices, such as Class I, Class II and Class III medical

devices, and cover all stages of the manufacture of the medical

device, such as:

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• Conceptualization and development

• Manufacture

• Packaging and labeling

• Advertising

• Sale

• Use of the product

• Ways in which the medical device is to be disposed after use

The WHO also sets out the role to be played by the various

players in the chain, such as the manufacturer, the vendor, the

user, the general public, the government and so on.

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The GHTF –now replaced by

the IMDRF

Although a number of regulations are present in various

countries of the world and in blocs such as the EU and the

medical device regulatory bodies in these markets are free

to formulate their own regulations; there is the existence of a

global instrument, the Global Harmonization Task Force

(GHTF), now known as the International Medical Device

Regulators Forum (IMDRF).

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The IMDRF is a takeoff from the GHTF. It is a mechanism for

exchanging information about medical devices that helps the

countries of the world bring in a level of harmonization and

standardization in the medical device regulations around the

world. Being a voluntary program; the IMDRF consists of

officials who represent the regulatory bodies of their respective

countries, and members of the regulated industries

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Core purposes of the IMDRF

A task force that is tasked with the formulation and

implementation of regulatory guidelines; the IMDRF has the

following purposes:

• Encouraging synchronization of the regulatory practices of

different countries

• Promoting the wellbeing of patients by boosting the quality,

efficiency and performance of medical devices by

harmonizing regulations

• Bringing about greater innovation in medical devices

through the use of technology

• Fostering international trade

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Quality Systems regulations

for medical devicesIn addition to the GHTF; there are also the Quality Systems

regulations for medical devices that need to be complied with.

The Quality Systems regulation for medical devices is the ISO

13485 standard. Considered the benchmark for ensuring

quality through standards and processes; the ISO 13485

standards concern the regulations by which the manufacturer

designs, manufactures, packages, labels, stores, installs,

services and handles post market operations of medical

devices. These regulations cover the controls, facilities and

methods the manufacturer uses for medical devices. For this

reason, the ISO 13485 covers the entire lifespan of the medical

device, and usually works in tandem with the regulatory

frameworks and systems of individual countries.

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Being the current standard for medical devices; the ISO 13485

offers a set of standards for implementation by medical devices

manufacturers. Although enacted as an independent standard;

the ISO 13485 is synced with ISO 9001, alongside with which it

is implemented. This is because of reasons of

complementarity: The ISO 13485 only prescribes steps for

implementing Quality Management Systems guidelines as they

exist and is not concerned with ways by which these processes

can undergo improvement over time. To overcome this, the

ISO 13485 standard is to be unified with other guidelines and

standards in future in phases.

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• The major objective of the ISO 13485 standard is to help

medical device manufacturers know how to put a medical

device risk management process in place. The aim of this

process is to help medical device manufacturers:

• Recognize underlying and existing hazards present in the

medical device

• Evaluate the inborn risks associated with the manufacture

of medical devices, and

• Develop steps to contain risk and implement and follow up

on the extent to which these measures have been effective.

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Risk management and ISO

13485

One of the main characteristics of the ISO 13485 standard is the guidelines it has on

ways by which a manufacturer of medical device needs to put a risk management

process in place and implement it. The ISO 13485 standard requires these risk

management processes which medical device manufacturers have to implement:

• Establishing a process that helps it to identify, manage and control the risks

relating to a medical device

• Entrusting the management with the responsibility of ensuring that the company’s

medical devices are subjected to this process

• Taking steps to properly and systematically document all the steps that go into

this process

• Implementing a risk management process is mandatory for all medical device a

medical devices company manufactures, which is to be embedded throughout the

lifecycle of the medical device

• Adherence to the risk management process, which is to be scrutinized and

documented at various stages of the device’s lifecycle

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