Professional Documents
Culture Documents
AAKASH DEEP
Department of Pharmaceutical Sciences, Chaudhary Bansi Lal
University, Bhiwani, Haryana, India
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Preface xiii
v
vi Contents
Index 165
Preface
The idea of writing this book was conceived when my own students found great diffi-
culty in getting the recent literature regarding the Regulation of Medical Devices.
A major aim of this book was to provide recent literature regarding the current
Regulation of Medical Devices. The current book is a compilation of a brief review
of various regulatory bodies of major developed and developing countries around the
world and the Registration Procedure of Medical Device of such Pharmaceutical
Regulatory Organizations in delivery of safe and effective healthcare products.
I thank the worthy Vice Chancellor of Chaudhary Bansi Lal University, Bhiwani,
Prof. Raj Kumar Mittal, for his constant motivation and support. I thank Dr. Jitender
Kumar Bhardwaj, Registrar, Chaudhary Bansi Lal University, Bhiwani, for the moti-
vation and guidance.
It is my proud privilege to express my sincere gratitude to Prof. Narasimhan B.,
Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, for
his constant unceasing encouragement to combine my mental images with emotion of
desire to accelerate their realization.
I gratefully acknowledge my Chairman Prof. Nitin Bansal, Department of
Pharmaceutcial Sciences, Chaudhary Bansi Lal University, Bhiwani, Dr. Prabodh
Chander Sharma, Delhi Pharmaceutical Sciences and Research University, New
Delhi, and Prof. D.N. Mishra for their blessings.
I feel to thank to my parents, Sh. Raj Karan and Smt. Kamla Devi and my better
half Priyanka, sisters Sharda, Sangeeta, and Meenakshi, and my kids Hargun and Seerat
who have helped me in bringing out this book.
I humbly and generously call upon all my colleagues to give due considerations to
this piece of art. Thanks are also due to my energetic and dynamic publisher Elsevier
Publishing Company to bring out this book well in time.
xiii
CHAPTER 1
1.1 Introduction
The term “medical device” includes everything from highly complex computerized
medical equipment to simple wooden tongue inhibitors. Unlike drugs, the fundamental
way of working the medical device on the physical body is not metabolic, immunologi-
cal, or medicinal.
“Medical device” means any device, implant, reagent, or titrator in the laboratory,
any program, tool, or any other similar or related material intended by the manufac-
turer for use alone or together with humans with one or more of the targets set for
• diagnosis, control, prevention, treatment, or relief from disease;
• diagnosis, monitoring, treatment, relief, or compensation for injury;
• investigate, replace, modify, or support anatomy;
• physiological process;
• support or preserve life;
• design control;
• disinfection of medical devices; and
• providing medical information through a laboratory examination of the physical
body samples that do not accomplish the intended primary action on or on the
physical body by medicinal, immunological, or metabolic means, but can be
accompanied in its function by these means [1].
1.6.1 Investigation
The concept may be an idea for a new or improved system based on the use of an
existing device. In any case, thorough research is essential to ensure a viable definition.
Many products will not progress beyond this stage because their developers have not
thoroughly researched their idea. They can, ideally, respond to the following
questions:
• Who is the target audience for this product?
• What are the threats associated with mechanical and manufacturing processed?
• Is the concept unique in relation to all or any other devices designed to perform a
similar function?
• It is best to discuss a concept with an experienced engineer who has previously
worked on similar medical devices. To help answer those questions, they will con-
duct a critical assessment of a commodity.
1.6.2 Design
The machine has been developed, reviewed, updated, and redesigned using agile
product engineering. Computer models and prototypes are used to test the design and
assess its marketability. Here are some tools to help you think positively:
• 3D printing: 3D printing made rapid prototypes available to the general public by
allowing manufacturers to create models quicker and gain a better understanding
6 Medical Device Regulations
of them. This gives the designer a rough idea that he or she can use to develop the
product.
• Powder Layer Mergers—a high-density laser that fuses powdered metal materials
into 3D models and shapes. Powder bed combinations enable designers to build
stronger designs, making them a common option for medical device prototypes.
• Computer numerical control (CNC) machining: this approach is particularly useful
when working with raw materials to create a design. Since the machine controls
manufacturing equipment and 3D printers, a complex, detailed design, and high-
quality prototypes are produced.
1.6.3 Validation
The FDA has developed guidelines for certain medical devices. The controls and para-
meters varied by device type, with devices being classified on a scale of one to three in
terms of their function, invasiveness, and risk level. When it comes to checking the
result and ensuring a positive outcome, the device's class will decide what controls
are required. Clinical trials should be performed and submitted at this stage, if they are
needed, so that the maker can request premarket approval.
1.6.4 Launch
• The content creator will begin promoting and selling its goods after obtaining pre-
sale approval from the FDA, if necessary.
• Premarket approval may be a an FDA message to content creators indicating that it
is secure for the general public.
• If the device requires such approval, it will not be possible to start marketing or
selling before receiving it. On the positive side, only about 5% of all medical
devices require this strict and costly process. This is great news for many young
creators, who may not have the $94 million needed to provide the general public
with a tool that requires premarket approval.
• To ensure that the materials comply with legislation and that the marketing strate-
gies are acceptable, marketing must work closely with a legal team. Marketing
messages and methods must be carefully planned through this matter and are likely
to be better managed by companies with specific medical device expertise.
of medical history and keep track of patient registries. This stage may also include
launching the device in secondary markets [13].
John Sevier, too, had more honors than those of a noble soldier.
In front of the courthouse at Knoxville is a plain stone monument
raised in his memory (Fig. 64), and down a side street is an old
dwelling, said to be an early statehouse of the commonwealth which
is still associated with his name. In 1785 the state of “Franklin” was
organized and named in honor of the illustrious Benjamin; but North
Carolina, being heartily opposed to the whole proceeding, put an end
to it without delay. Sevier, as governor of the would-be state, was
imprisoned, but escaped, to the delight of his own people, who were
always loyal to him. They sent him to Congress in a few years and in
1796 made him the first governor of Tennessee. He enjoyed many
honors until his death in 1815, which came soon after that of his
more quiet friend, James Robertson. Both of these wilderness men
had much to do with planting the American flag between the
Appalachian mountains and the Mississippi river.
CHAPTER XIV
CITIES OF THE SOUTHERN MOUNTAINS