regulation of medical devices in india, licensing requirement and their procedure by amended medical device rule 2017

1. By Atul Bhombe
M.Pharmacy (RA) First yr.
Sanjivani college of pharmaceutical
education & research,Kopargaon MH
31/3/2021
Regulatory requirement and
Approval Procedure for Medical
Devices In India

2. Introduction
 “Devices intended for internal or external use in
the diagnosis, treatment, mitigation or prevention
of disease or disorder in human beings or
animals”
 In the past, there were no regulations for the
manufacture of these devices in India.
Manufacturers could manufacture any kind of
medical devices without any jurisdiction.
 But in the year 2006, it became compulsory for
the medical devices entering India to be in
compliance with the Indian Medical Device
Regulations set forth by the CDSCO.
 Medical Devices are notified as Drugs under Drug
& Cosmetic Act

3.  The standards of quality and safety of medical
devices are regulated in India by a law called The
Drugs and Cosmetics Act, 1940 (“D&C Act”).
 The scope of D&C Act is restricted to only those
medical devices which are notified by the
Government from time to time as “drugs”
(commonly referred to as “notified medical
devices”).
 The Medical Devices Rules, 2017 (“MDR”) have
been framed under D&C Act. These rules lay
down comprehensive quality requirements to be
followed by marketers / importers / manufacturers
/ sellers of notified medical devices.

4. Regulatory Body For Medical
Devices
Drug Controller General of India (DCGI)
Deputy Drug Controller
Assistant Drug Controller
Medical Device
Cell
Diagnostic
Drug
Inspector
Technical Data
Associate
Drug
Inspector
Technical Data
Associate

5. Function of Medical Device
Division
 Import Registration and Licensing of Medical
Devices
 Approval of New Medical Devices
 Manufacturing License to Indigenous
Manufacturer under CLAA Scheme
 Grant of Test License
 NOC’s for Import/Clarifications
 Neutral Code For Export
 Clinical Trials

6. Classification Of Medical
Devices
 Classification of medical device is based on risk
factor.
Class A
(Low Risk)
Class B
(Low-
Moderate
Risk)
Class C
(Moderate-
High Risk)
Class D
(High Risk)
•Bandages
•Tongue
depressors
•Surgical
dressing
•Hypodermic
Needles
•Suction
Equipments
•Lung
Ventilator
•Bone
fixation
plate
•Heart valves
•Implantable
defbrillator
•Copper T

7. Registration medical devices
State
licensing
authority
For
class A
& B MD Central
licensing
authority
For
class C
& D MD

8. 1. Determining whether the
product requires registration or
not
 Until 11th February 2020, only 37 categories of
medical devices were treated as drugs, however, as
per the new notification from the Government of India,
the medical devices (Newly Notified Medical Devices)
that fall under the following definition are now treated
like “drug” and regulated by Drugs Controller General
of India (DCGI) and MDR.
 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 ―

9. 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) the 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.”

10. 2. Appointing an authorised Indian
agent
 For foreign manufacturer – that representative
who will act on their behalf as the point of contact
for inspection authorities
 These representative act as a contact between
the manufacturer & CDSCO’s medical device &
diagnostic division who will assist in the
procedure of registration

11. 3.Submitting the regulatory
dossier under form MD-1
 Compilation of registration dossier should be done as
per the performa provided by CDSCO along with
document .
 Online portal for medical devices enables applicant to
submit online application for MD regulatory process to
CDSCO.
 Form MD-1 should duly filled, signed & stamped by
Indian agent( for foreign manufacturer) along with
name and designation.
 Require Documents-
1. Form MD-1
2. Challen
3. ISO 13485 certificate
4. Full quality assurance certificate
5. Plant master file
6. Device master file

13. 4. Obtaining registration certificate
in Form MD-2
 If the application complete in all aspects the
licensing authority will, within 9 months, issue
such registration certificate in Form MD-2
 Validity period of registration certificate is 3
years.

14.  Process flowchart for obtaining
manufacturing license…
 As per MDR 2017

20. Reference
 https://arogyalegal.com/2020/article/all-medical-
devices-in-india-to-be-regulated-as-drugs-
medical-devices-amendment-rules-2020/
 https://cdsco.gov.in/opencms/opencms/en/Medica
l-Device-Diagnostics/Medical-Device-Diagnostics/
 http://docplexus-insights.com/blog/medical-
devices-amendment-rules-2020/
 “Medical Device Rule- 2017” by CDSCO