This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.

1. INDIAN MEDICAL DEVICE RULES
2017
PRESENTED BY:
Arshad Ibrahim(M. Pharm)
NANDED PHARMACY COLLEGE

2. What are medical devices?
• Section 3 (b) (iv) defines medical devices as-
Devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human
being or animals.

3. Why regulation rules are necessary for such devices?
 Prior to 2005 there was no separate rules for medical devices.
 Increasing scope and use of medical devices enforces the government to
make regulations in order to improve safety and quality of such devices.
 In exercise of power conferred by section 12 and section 33 of the DRUGS
AND COSMETICS ACT 1940, the central government,
after consultation with the drug technical advisory
board, makes the rules which are called as medicinal
device rule 2017 which are come in to force with effect
from 1st Jan 2018.
 It includes- 12 chapters and 8 schedules

4. • Chapter I – Preliminary
It contains title of gazette, some important definitions and
applications of these rules i.e. these rules shall be applicable in respect of
surgical & blood components, mechanical contraceptives, insecticides,
disinfectants etc.
 Chapter II – Regulation of medical devices
It contain
1.Classification
(i) Low risk ( Class A)
(ii) Low moderate risk (Class B)
(iii)Moderate high risk (Class C)
(iv)High risk (Class D)
2.Grouping
3.Essential principle of manufacturing (Safety and quality)
4.Product standards – device shall comply with standards laid
down by section 3 of BIS ACT 1985
or ISO

5. Chapter III – AUTHORITIES, OFFICERS AND BODIES
• The Central Licensing Authority shall be the competent authority for
enforcement of rules related to import, class C and class D, device
manufacturing, clinical investigation, clinical performance evaluation etc.
• The State Drug Controller is the state license authority for enforcement of rules
related to manufacturing of class A and B device manufacturing,
sale, stock, exhibit or offer for sale of medical devices.
• Controlling Officer is the any officer having rank not below
the assistant drug controller and shall exercise power and
function under these rules by order of drug controller
general of India or state drug controller.

6. • NATIONAL ACCREDITATION BODY – Government organization who
fulfills criteria time to time specified by government, main functions are
Conformity assessment, audit of notified body, lay down of standards for
accreditation
• NOTIFIED BODY – Organization accredited by national accreditation body
.
• MEDICAL DEVICE TESTING OFFICER – Central Government may
designate government analyst as Medical Device Testing
Officer under section 20 of act.
• MEDICAL DEVICE OFFICER - State or Central
Government may designate Inspector as Medical Device
Officer under section 21 of the ACT.

7. Chapter IV – MANUFACTURE OF MEDICAL DEVICES FOR SALE
OR FOR DISTRIBUTION
Any person for manufacturing of class A and class B devices apply under sub
rule (1) through online portal of ministry of health and family welfare to in form
MD-3 for license and MD-4 for loan license with respective documents
specified in part II of fourth schedule with an undertaking that, the quality
management system requirements of schedule V shall be complied.
The audit of manufacturing site for class A devices shall be carry out by notified
body within 120 days from grant of license as notified in
third schedule while for class B devices under rule 13 audit
of site carried out before granting of license. On satisfaction
government may grant license in form MD-5 and loan license
in form MD-6 for both class A and B devices.
For class C and D medical devices application process is similar
to class A and B but in form MD-7 for license and MD-8 for

8. -loan license to central government. License granted by central Government
in form MD-9 and loan license in form MD-10.
• The manufacturing site for all classes of devices shall comply with
requirements of quality management system under schedule V also the
appointed staff shall possess either diploma with minimum four year
experience or degree with minimum two year experience in engineering or
pharmacy or other.
• In case of change of constitution , licensee shall inform to authority within
45 days and apply for new license under (1) of rule 20 or (1) of rule 21.
• small quantity of medical devices is manufactured for
evaluation and test license for such shall be obtained from
central body in form MD-13 after making application in
form MD-12 .
• License conditions are-
License shall be produced when requested, licensee shall
obtain prior approval from state or central authority before
making any major or minor changes as specified in
schedule VI, licensee shall maintain audit, sample from
each batch, record of manufacturing and sale.

9. Chapter V - IMPORT OF MEDICAL DEVICES
• Authorized agent having license to manufacture for sale shall apply for
grant of import license for medical device to central authority in form MD-
14 in a process similar to previous one, after complete process license
granted by authority in form MD-15.
• if central body is doubtful about quality of product and subject it for
evaluation then expenditure of evaluation process shall be paid by agent or
licensee.
• On receipt of application under sub rule (1) of rule 34 the central authority
may cause inspection of overseas manufacturing site and
applicant shall be liable to pay expenditure.
• Small quantity of investigational medical device, the
import of which is not allowed but approved in country
of origin may allowed to import by centre for treatment
of patient suffering with life threatening disease, on
application made by medical officer through
superintendant in MD-18 and license for which is granted
by central authority in form MD-19.

10. Chapter VI - LABELING OF MEDICAL DEVICES
• Particulars like name of device, use, address of manufacturer, net product
quantity, manufacture and expiry date, batch or lot number, special storage
and handling conditions, manufacturing license number etc shall be printed
in indelible ink on the Label.
• Shelf life shall be determined and ordinarily not exceeding sixty months.
Chapter VII - CLINICAL INVESTIGATION OF MEDICAL DEVICES
• No one shall conduct clinical investigation on human
participants except in accordance with these rules.
• The ETHICS COMMITTEE constituted under rule 122D
of DRUG AND COSMETICS RULES 1945 for purpose
of clinical investigation and clinical performance
evaluation.

11. • Application for clinical investigation shall be made in form MD-22 by sponsor
and shall accompanied with information in seventh schedule , after process
license may granted by central authority in form MD-23.
Pilot clinical investigation means investigation carried out for the first time in
human .
Medical device requiring clinical investigation but claiming substantial
equivalence to predicate device shall not be marketed unless central authority
approve it.
when participant get injured during investigation then under
rule 52 they seek for medical management as compensation,
or if participant gets died then specified compensation
under rule 122DAB shall be provided by sponsor.

12. Chapter VIII –IMPORT OR MANUFACTURE OF MEDICAL DEVICE
WHICH DOESN’T HAVE PREDICATE USE
Application shall be make in form MD-26 by either agent or manufacturer
along with information specified in part 4 of IV schedule and permission
may granted by centre in form MD-27.
Chapter IX – DUTIES OF MEDICAL DEVICE OFFICER,
DEVICE TESTING OFFICER AND NOTIFIED BODY
• Inspect, not less than once in a year, all manufacturing
sites licensed by the Central Licensing Authority or
State Licensing Authority.
• Take samples of medical device OF which the Medical
Device Officer has reason to suspect contravention of
the provisions of the Act and send them for test or evaluation.
• Maintain a record of all inspections

13. Chapter X – REGISTRATION OF LABORATORY FOR TEST OR .
. EVALUATION
Application for license shall be made in form MD-39 with
information specified in sub rule (2) and after device
officers investigation license may granted in form MD-40.
• Chapter XI is concerned with sale of medical devices in relation to
provision part iv related to sale of drug other than
homeopathic medicine.
• Chapter XII associated with miscellaneous points
like export of devices, exemptions etc

14. SCHEDULE DESCRIPTION
First -Parameters for classification of medical devices
Second - Fee payable for license permission and registration
Third - Document required for registration of notified body
Fourth - Document required for license
Fifth - Quality management system for medical devices and
diagnostic medical devices
Sixth - Post approval changes
Seventh - Requirements for permission to import or manufacture
investigational medical device
Eighth - Exemptions