Medical Plastic Data Service Magazine

 
 

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 30th Year of Publication
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Quality

REGULATORY TESTING OF MEDICAL GRADE PLASTICS, RUBBERS & PACKAGING MATERIALS

 

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

 
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