What is a Medical Device ?
Devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of diseases or disorders in
human beings or animals.
Who is the Regulatory Body ?
• The Drugs Controller General (India) of
Central Drugs Standard Control Organization
(CDSCO) is the Regulatory Authority that
Governs the Import, manufacture, sale and
distribution of Medical Devices under the
Drug & Cosmetic Act 1940 & Rules.
Medical Devices Regulated In India
• Only Medical Devices that are Notified
under Drugs and Cosmetics Acts are Regulated
in India.
CLASSIFICATION OF MEDICAL DEVICES
• The great variation present in the medical device
industry means that devices can be classified in a
number of ways. Devices can be categorized by:
• . The risk associated with improper use or a failure
(generally high, moderate, and low).
• . Conditions of processing (reusable, disposable, capital
equipment, etc.).
• . Conditions of the therapy (invasive, noninvasive).
• . Conditions of shipping and handling (capital
equipment, commodity surgical, etc.).
GENERAL CONSIDERATIONS FOR THE
DEVELOPMENT OF MEDICAL DEVICE
1.PACKAGING
Packaging Functions As a general rule, packaging
performs three broad functions—protection,
utility, and communication—within three
environments: the physical, ecospheric, and
human.
2.Protection.
• Protection refers to protection of the medical device
from the environment and vice versa.
• For medical device packaging, product protection is
necessary to maintain package integrity throughout its
entire life, including: sterilization, shipping, storage,
handling, and use.
• Typical issues include protection from shock and
vibration, crushing, puncturing, tearing, bursting,
splitting, pinholing, humidity, heat, and so on.
3.Utility.
• Utility is related to the ease of use of the system.
For many medical devices, quick and easy opening
and removal of contents are crucial. While this
consideration is also important for devices with
relatively low risk, such as an adhesive bandage, it is
extremely critical for sterile medical devices that are
used in surgical arenas where the packaging must
allow the device to be removed without
contamination.
4.Communication.
• As with consumer goods packaging, secondary and primary medical device
packages are a means to convey information through graphics, materials, and
shape.
• Packaging communication operates at different levels, depending on the type of
medical device.
• For over-the-counter (OTC) medical devices, such as condoms, glucose meters,
adhesive bandages, thermometers, and so on, the communication role involves
motivating a purchase, as well communicating important information for the safe
and effective use of the medical device.
• Information may include directions, warnings, product benefits, brand
differentiation, and so on.
• A very important aspect of package communication is product identification.
• This is especially true for devices that go into institutional settings, such as
hospitals, where personnel may have to identify the correct device for a patient
when seconds count
• 5. Package Forms, Materials, and Sealing
• Selection of packaging style can impact package
integrity.
• The type of package is largely driven by the
characteristics of the device being packaged. These
include size, shape, profile, irregularities, density,
weight, and configuration (e.g., single unit or kit).
• For example, a high-profile, irregularly shaped
device would be more securely packaged in a
semirigid plastic tray than in a
flexible pouch. As such, during the early design
stages, it is critical to define the following
parameters:
. Critical product characteristics.
. Type(s) of protection required (physical, ultraviolet
light, O2, water vapor transmission, etc).
. Type of sterilization process.
. Where and how the product is going to be
dispensed (OTC, surgery, etc.).
• 6 Thermoformed Trays.
• Thermoformed trays are commonly used for surgical procedure
kits and are ideal for high-profile, irregularly shaped devices.
• There are two types of thermoformed trays: semirigid and
flexible. The most important difference is that semirigid trays
are structurally self-supporting.
• They can provide good physical protection and are suitable for
multicomponent applications.
• Formed flexible packaging is more suitable for low-cost devices
and for simple tray configurations, but do not offer the same
degree of structural protection as the semirigid trays.
• The following characteristics are highly desirable for all
formable materials:
• . Ease of forming: The container should be free from
mechanical stress to avoid sterilizer creep or seal
fatigue.
• . Heat resistance: The container should withstand heat
sealing without deformation of seal flanges.
• . Product compatibility: It is important that packaging
components be nonreactive with the product.
• . Sterilization compatibility: The packaging must
withstand the rigors of sterilization and, in many.
