Medical Plastic Data Service Magazine



Our 28th Year of Publication
Page  2 of 7

Cover Story

Regulatory Compliance For Medical Device Component Manufacturers


Mr. Sanjay Shah,
Managing Director,
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 & treatment.

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 pharmaceuticals


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 effectiveness.


Medical devices are, nonetheless, evaluated for efficacy and safety, based on data acquired from clinical investigations.


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 components.


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.


Advertisers' Index

Accuprec Research Labs Pvt. Ltd., India
Ambica Medicare Engineering, India
Nu-Vu Conair Pvt. Ltd., India
Divya Steri Solutions Pvt. Ltd., India
ET Elastomer Technik, Germany
Eewa Engineering Co. Pvt. Ltd., India
Ineos Styrolution India Ltd., India
I-Kare Polyalloys Pvt. Ltd., India
KLJ Group, India
Lubrizol Advanced Materials India Pvt. Ltd.
Kuraray India Pvt. Ltd., India
Maider Medical Industry Equipment Ltd.China
Medicall 2019, India
Ferromatik Milacron India Pvt. Ltd., India
GLR Laboratories Pvt. Ltd., India
Pashiba Lifescience, India
Plastivision India
Pradeep Surgipack, India
PVC Colouring Compounding & Processing, India
Qosina, USA
Raumedic AG
SMC Medical Manufacturing Pvt. Ltd., India
Sterimed Medical Devices (P) Ltd., India
Steri Techno Fab, India
Tekni-Plex India Pvt. Ltd., India
Twist Engineering Works,India
Yuhuan Shengjiu Mould Co., Ltd., China

Airways Surgical Pvt. Ltd., India

Alpha Medicare and Devices Ltd., India
Alpha Therapeutics Pvt. Ltd., India
Ami Polymer Pvt. Ltd., India
Angiplast Pvt. Ltd., India
Appasamy Associates, India
Beacon Plastics, India
Delux Surgical, Inida
Ignisol Mediplas Corporation, India
Jain Rubbers Pvt. Ltd., India
Operon Strategist, India
R.R. Patel Gases (P) Ltd., India

Proven Trade Contacts, India

Sanidhya Enterprise, India
Surgi Pack India Pvt. Ltd.
Unikal Consultants, India
Vinit Performance Polymers Pvt. Ltd., India
Aircity, India
Amigo Surgi Care Pvt. Ltd., India
Angel Products, India
Apex Medical Devices, India
Jimit Medico Surgicals Pvt. Ltd.
Kavya Packaging, India
Life-O-Line Technologist, India
Mesco Surgical, India
Morrisons Lifecare Pvt. Ltd., India
National Healthcare, India
Pharmadocx, Inida
S. Nath & Co., India
Unikal Consultants, India
Venus Industries,India, Mobile : 9825747495
Zinkal Products, India
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