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REGULATORY TESTING OF MEDICAL GRADE PLASTICS, RUBBERS &
PACKAGING MATERIALS
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Dr. Manish Rachchh
Director (R&D) and CEO
Accuprec Research Labs Pvt. Ltd. Ahmedabad |
About Author:
Dr. Manish A. Rachchh is working as a director (R &
D) and CEO of Accuprec Research Labs Pvt. Ltd.,
Ahmedabad, Gujarat, India.
Accuprec is globally reputed medical device testing
lab working with 200+ clients globally and accredited
with FDCA, GLP, NABL, CPCSEA, ISO 9001:2015, AYUSH,
DSIR, CDSCO & DUNS. Accuprec provides all above
mentioned seven types of testing ranging from 1)
Physical testing to 7) Stability testing (except
electrical testing).
For any further information, you can write your query
to
manish.rachchh@accuprec.com (M) +91-9099981023 |
Abstract:
This paper describes that how changes in regulatory
environment or regulatory policies affects the medical
device segments. In the present article, we have specify
the medical device (Class A, B, C & D), which are notified
and/or going to be notified and regulated in India by
CDSCO and also specify the required tests for Raw material
and Components of Medical Devices. CDSCO has published 24
broad categories comprising 2500+ medical devices, out of
which class A & B devices will come into the regulation
from 01.10.2022 and class C & D devices will come into the
regulation from 01.10.2023. So all medical devices and its
raw material manufacturer have to start doing
pre-preparation for the compliance of the same by starting
appropriate testing as recommended by Indian MDR 2017.
Introduction: Rapid
growth and updation in medical device regulatory
environment is a worldwide phenomenon. The primary purpose
of implementing regulatory systems for medical devices is
to protect public health and ensure safety and
performance. Medical device testing is the process of
demonstrating that the device will reliably and safely
perform during its intended use. Definitions (As per CDSCO
MDR Rules, 2017): 1.
Medical Device: All devices including an instrument,
apparatus, appliance, implant, material or other article,
whether used alone or in combination, including a software
or an accessory, intended by its manufacturer to be used
specially for human beings or animals which does not
achieve the primary intended action in or on human body or
animals by any pharmacological or immunological or
metabolic means, but which may assist in its intended
function by such means for one or more of the specific
purposes of – i. Diagnosis,
prevention, monitoring, treatment or alleviation of any
disease or disorder;
ii. Diagnosis, monitoring, treatment, alleviation or
assistance for, any injury or disability;
iii. Investigation, replacement or modification or support
of the anatomy or of a physiological process;
iv. Supporting or sustaining life;
v. Disinfection of medical devices; and
vi. Control of conception
2. Raw material: Raw or unprocessed materials are
basic components used in the manufacture of medical
devices and their components. There are a wide range of
raw materials available to organizations manufacturing
medical technology, including additives, alloys, ceramics,
and gels.
3. Packaging material: Packaging Material is any
article or substance which is intended to use to protect
the medical device from external environment. It is made
up of known and traceable materials. Non-toxic,
non-leaching and odorless. It is free of holes, cracks,
tears, creases and localized thinning.
4. Medical Grade Plastic: It refers to plastics
designed to make medical products. It is high wear,
temperature resistant and corrosion resistant. It is used
in manufacturing many types of medical devices and
equipment from MRI machines to diagnostic wands as well as
medical and surgical tubing.
Table 1: List of Medical Device are notified and
regulated in India by CDSCO
| Sr. |
Name of the Device |
Notification Number |
Date of Notifiication |
| 1 |
Disposable Hypodermic Syringes |
GSR 365 (E) |
17-03-1989 |
| 2 |
Disposable Hypodermic Needles |
GSR 365 (E) |
17-03-1989 |
| 3 |
Disposable Perfusion Sets |
GSR 365 (E) |
17-03-1989 |
| 4 |
In vitro Diagnostic Devices for HIV,
HBsAg and HCV |
GSR 601 (E) |
27-08-2002 |
| 5 |
Cardiac Stents |
S.O. 1468 (E) |
06-10-2005 |
| 6 |
Drug Eluting Stents |
S.O. 1468 (E) |
06-10-2005 |
| 7 |
Catheters |
S.O. 1468 (E) |
06-10-2005 |
| 8 |
Intra ocular lenses |
S.O. 1468 (E) |
06-10-2005 |
| 9 |
I.V. Cannulae |
S.O. 1468 (E) |
06-10-2005 |
| 10 |
Bone cements |
S.O. 1468 (E) |
06-10-2005 |
| 11 |
Heart Valves |
S.O. 1468 (E) |
06-10-2005 |
| 12 |
Scalp Vein Set |
S.O. 1468 (E) |
06-10-2005 |
| 13 |
Orthopedic Implants |
S.O. 1468 (E) |
06-10-2005 |
| 14 |
Internal Prosthetic Replacements |
S.O. 1468 (E) |
06-10-2005 |
| 15 |
Ablation Devices |
S.O. 237 (E) |
25-01-2016 |
CDSCO has published broad 24
category of medical devices as per their healthcare
categories, which are as of now nonregulated and listed as
non-notified devices. Under this 24 categories approximate
2500+ devices are fall, which come into class A to D.
The registration of all such non-notified class A, B, C &
D devices have been kept voluntary by CDSCO for a period
of 18 months w.e.f. 1st April 2020 i.e. till 30-09-2021.
Voluntary Registration of class A & B devices shall be
followed by mandatory registration after 30-09-2022.
From 01-10-2022, all class A & B devices will fall under
CDSCO licensing regime.
Similarly, the registration of all such non-notified class
C & D devices shall be followed by mandatory registration
for 24 months after 18 months voluntary registration
period is over i.e. 01-10-2021 to 30-09-2023.
From 01-10-2023, all such class C & D devices will fall
under CDSCO licensing regime.
In brief, any item that is going to be used in the
hospital / healthcare sector for diagnosis, prevention,
monitoring, treatment or alleviation of any disease or
disorder will come under the regulation of CDSCO from
30.09.2022 (Class A & B) OR 1.10.2023 (Class C & D).
So the manufacturer of above devices as well as their raw
material suppliers have to do compliance of all testing /
qualification requirement laid down for the respective
products. Type of testing
required for Raw Material & Components of Medical devices
1. Physical & Mechanical testing
2. Chemical testing
3. Microbiological testing
4. Biological Safety testing
5. Biocompatibility testing
6. Packaging testing
7. Stability testing
8. Electrical testing |
