Regulatory Compliance For Medical Device Component
Mr. Sanjay Shah,
Unikal Consultants, Ahmedabad
In the healthcare world we know
what are called medical devices and what the
definition of medical device is. We also know their
importance in today’s patient health management &
At the same time generally we know
a lot more about medicines, even about alternate
medicines like ayurvedic, homeopathic or unani but the
awareness of what are called
medical devices and for need of medical devices was
till now very limited, sometimes confusing.
Let us analyze this a little dipper
to understand need for regulating medical devices and
their “raw materials”.
There are many dissimilarities
between medicines and medical devices but they are
both necessary in patient cure and management of
improving their life. Broadly described as follows:
1. Medical devices are mechanical, rather than chemical
Medical devices are based on biomedical engineering and,
as a general rule, either permanently or temporarily
replace a body function. At the soft end, they are simple,
everyday products like sticking plasters or spectacles; at
the sharp end, they might be sophisticated surgical
supplies, like cardiac stents or joint prostheses. By
contrast, pharmaceuticals are medicines, designed to
engage the body’s chemistry.
2. Medical devices have different efficacy dynamics to
The efficacy of a medicine is simpler to demonstrate than
for a medical device, because it is determined by the
pharmacodynamics of its active ingredient. The
effectiveness of a medical device depends upon many more
variables – it design, the care setting, individual
patient characteristics and the skills and experience of
the clinician ‘applying’ the device.
3. Research and development (R&D) models are different
Designing of a medical device is a complex process and
needs many different studies before even it is used. So
its components and parts are very critically controlled.
Most medical devices cannot be evaluated using randomised
clinical trials due to ethical and practical issues in the
choice of comparator – for example, what would be an
ethical comparator for a cardiac pacemaker? One more
critical aspect of design of medical device is that there
cannot be a placebo, very unlike medicines to compare the
Medical devices are, nonetheless, evaluated for efficacy
and safety, based on data acquired from clinical
4. Medical devices have regulatory systems based on
shorter product life cycles
Like pharmaceuticals, the medical device industry has its
own regulatory systems. Medical devices have shorter
product life cycles, since technical improvements are
typically available within two years of a previous
iteration, whereas improvements in medicines are more
likely to take decades. Trying to apply the same
regulations to medical devices as to pharmaceuticals would
therefore delay access to vital medical resources and
procedures without increasing patient safety.
5. The complete performance of medical device is based
on their risk to benefit assessment.
This means that not only the medical device used should be
useful but at the same time should have benefits more than
the risk involved in using them.
6. Sales and marketing models differ
In pharmaceuticals, the prescribing doctor is the primary
target of sales and marketing activities. In medical
devices, there are many more stakeholders who can
influence the adoption and use of a device, including
hospital managers, nurses and case workers. Medical
devices therefore have greater emphasis on training,
education, service and maintenance, as well as
distribution, which greatly impacts their business models.
Let us analyse above differences to better understand need
for regulations for medical devices and criticality of its
Medicines have active compounds and filler or inactive
compounds. It is easier to understand and control these
active compounds. Medical devices have many components and
all of them form a critical component of a device.