Regulatory Samvad

…For your information

VOL.NO.01 ISSUE- 02 FEBRUARY 2020 MONTHLY

 Editor’s message
 Regulation for manufacture medical device for purpose of clinical investigations,
test, evaluation, examination, demonstration or training
By Pradeep Kumar Verma
 At a Glance- Indian Regulatory Updates of February 2020
By Tanveer Ahmad
 Regulation on Medical Device and In vitro Diagnostic manufacturing
By Pradeep Kumar Verma
 Global Regulatory at a glance
By Pranita Dhage & Tausif Ahmad, RPh

OTC Compliance
Legislations
Biologicals Act
FDC Cosmetics
Medical Devices
Drugs Pharmacovigilance
Regulatory Affairs
Rules
Clinical Research
Phytopharmaceuticals FMD GRP
Guidelines Regulations
GCP
Veterinary Medicine
Vaccines
 Page No. 1

Chief Editor
Mr. Ravindra B Joshi
Editor
Dr. Sangamesh B Puranik
Executive Editor
Mr. Tausif Ahmad
Associate Editors I am happy to release second issue of "Regulatory Samvad-for your
Mr. Arun Mishra information", an astounding initiative by the Association of

Mr. Rahul Mehrotra Regulatory Affairs Professionals (ARAP) for knowledge sharing and
providing regular updates in the field. Being a platform for
Publication Head
enlightening young minds regarding the regulatory initiatives and
Dr. Pavan P.
engaging them in discussions regarding the regulatory affairs, this is
Member Editorial Board an excellent e bulletin that is useful to both the fresher’s and masters

 Mr. Rajeev Kumar in the field.

 Mr. Varun Kumar
 Mr. Ankush Pandey
 Mr. Fayzul Islam Heartfelt gratitude to all those working to drive this e bulletin towards
 Mr. Tanveer Ahmad success and best wishes to them!
 Dr. Mohd Mir
Dr. S.B. Puranik
 Dr. Neeraj Kumar (President – ARAP)
 Mr. Krishan Tyagi Editor, Regulatory Samvad
 Mr. Pradeep Kumar
 Mr. Atul Thakran
 Ms. Disha Shetty
 Ms. Pranita Dhage

Disclaimer- Opinions expressed by the authors of individual articles do not necessarily represent the official view of ARAP
and those gathered from the public domain for information only and it does not contain (legal) advice.
 Page No. 2

Regulation for manufacture medical device for purpose of clinical investigations, test, evaluation,
examination, demonstration or training.
By Pradeep Kumar Verma
Test licence to manufacture for test, evaluation, clinical investigations, etc.,
(1) Small quantity of Class A or Class B or Class C or Class D of medical devices may be manufactured for the purpose
of clinical investigations, test, evaluation, examination, demonstration or training for which an application shall be
made in Form MD-12 to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second
Schedule.
Fees: - Test licence to manufacture for clinical investigations, test, evaluation, examination, demonstration or training
for each distinct medical device- five hundred rupees.
(2) The application made under sub-rule (1) shall also be accompanied with the following documents, namely:—
(a) brief description of the medical device including intended use, material of construction, design and an undertaking
stating that the required facilities including equipment, instruments, and personnel have been provided to
manufacture such medical devices; (b) List of equipment, instruments; (c) List of qualified personnel; (d) Copy of
manufacturing licence issued under these rules, if any; (e) Approval letter authorizing to undertake research and
development activities issued by any Government organization, if any.
(3) The Central Licensing Authority, after enquiry, if any, as may be considered necessary, on being satisfied that the
requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may reject the
application for reasons to be recorded in writing, within a period of thirty days from the date the application is made
under sub-rule (1).
(4) The licencee shall maintain a record of the details of quantity of the product manufactured under test licence.
Validity of licence - A licence granted under sub-rule (3) shall, unless cancelled earlier, remain in force for a period of
three years from the date of its issuance.
Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc,— A licence in Form MD-
13 under rule 31 shall be subject to the following conditions, namely:—
(a) The licencee shall use the medical device manufactured under licence granted under sub-rule (3) of rule 31
exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or training at the
place specified in the licence;
(b) The licencee shall allow any Medical Device Officer to enter, with or without notice, the premises where the
medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation, examination,
demonstration or training is being conducted on such device;
(c) The licencee shall maintain a record of the quantity of medical device manufactured, tested and stocked and its
disposition.
Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc.,— (1) Where any licencee
under rule 31 contravenes any provision of these rules, the Central Licensing Authority, shall, issue a show cause
notice to such licencee asking, as to why an order should not be made to cancel the licence.
(2) The Central Licensing Authority shall, after giving an opportunity to the licencee to explain in writing licencee’s
defense, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
(3) A licencee, whose licence has been cancelled, may appeal to the Central Government within forty five days from
the date of the order.
 Page No.3

At a Glance- Indian Regulatory Updates of February 2020

By Tanveer Ahmad

Notice regarding officials from Veterinary Division

CDSCO issued public notice on 31st Jan 2020 that the officials from Veterinary Division will be available at (Public
Relation Office) PRO (HQ), New Delhi on every Wednesday (Forenoon).
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num
_id=NTYzNw==

Draft of the Drugs and Magic Remedies objectionable Advertisements Amendment Bill 2020”
Government of India, Ministry of Health & Family Welfare issued “Draft of the Drugs and Magic Remedies
objectionable Advertisements Amendment Bill 2020” on 03 Feb 2020 & solicit suggestions /comments/objections
from the public/stakeholders with regard to the said draft Bill. The suggestions/comments/objections may be
forwarded within 45 days from the date of issue of this Notice by email at drugsdivmohfw@gov.in or by post to
Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Room No. 414A, D Wing, Nirman
Bhawan, New Delhi - 110011. The suggestions/comments/objections received on the above email/address within
the period of 45 days shall be taken into consideration for finalization of the notification.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num
_id=NTU0NQ==

Notice to manufacturers regarding extension in time limit for submission of application to FDCs

CDSCO issued noticed regarding Notice on 07th Feb 2020 regarding Pathway for subsequent manufacture of
category‘d’ FDCs as per Prof. Kokate Committee Report-extension in time limit for submission of application. The
manufacturers who are holding licenses from State Licensing Authorities before 01.10.2012 and didn't apply to DCG
(I) were required to present their application to the directorate before 22.11.2019. The extension date were given
to submit application to FDCs by 30.05.2020. In the view of above, without prejudice to legal validity of such licenses,
all concerned manufacturers/stakeholders are requested to submit their application along with requisite fees as
specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019 by 30.05.2020.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num
_id=NTU0Ng==
 Page No.4

CDSCO issued alert regarding Drug Alert list for month of January 2020

CDSCO issued alert on 10th Feb 2020 regarding Drug Alert list for month of January 2020.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?nu
m_id=NTU0Nw==

PRO details of all Zones/Sub Zones.

CDSCO issued noticed regarding Notice on 13th Feb 2020 regarding PRO details of all Zones/Sub Zones.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?nu
m_id=NTU2Mg==

Updating in FAQ of New Drugs and Clinical Trials 2019

CDSCO issued notice on 18th Feb 2020 regarding FAQ of New Drugs and Clinical Trials 2019, The FAQs on New Drugs
and Clinical Trial Rules 2019 are already uploaded on website but concern have been raise regarding the
applicability of the rules in case of drugs not considered as new drugs as well as submission and processing of
applications for grant of permission to manufacturer trial batches of new drug or investigational new drug for test
and analysis, CT or BA/BE study. In view of this, three questions (No. 01, 47 & 65) are updated and one additional
question is included for bringing clarity in these aspects.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?nu
m_id=NTU4OA==

Notice regarding in the case of 294 FDCs

CDSCO issued notice on 20th Feb 2020 Consideration of the direction of Hon'ble Supreme Court of India in the case
of 294 FDCs regarding. It has been considered that manufacturer/stakeholders may submit the information/data
with respect to 49 FDCs as well as 17 FDCs by 30.05.2020. In case of failure to submit the data/information by
30.05.2020, the decision will be made by the judgment of the Hon'ble Supreme court.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?nu
m_id=NTU4OQ==
 Page No.5

Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019
CDSCO issued notice on 20th Feb 2020 regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New
Drugs and Clinical Trials rules 2019. Notice No. 12-01/20-DC (Pt 51) has been issued on 18.02.2020 giving clarity on
submission and processing of such applications for grant if permission to manufacture trial batches of new drug or
investigational new drug for test and analysis, CT or BA/BE study. To streamline the processing, it has been decided
that, such applications will be processed by CDSCO(HQ)/Zonal/Sub-Zonal office, as the case may be, within 07 working
days of the receipts of applications.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_i
d=NTYyMQ==

CDSCO Notices for streamlining applications for new drugs, clinical trials & BA/BE studies

CDSCO issued Notices on 21st Feb 2020 for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/
Bioequivalence (BA/BE) Studies/ grant of COPP
1. Permission to conduct BA/BE study and Clinical trial.
2. Approval of FDCs containing new drugs.
3. Fixing of limit of impurities in the specification of INDs.
4. Pre-submission meeting.
5. Sub-acute toxicity study report for injectable products for BA/BE study in human for export.
6. Requirement of Stability Data for COPP -regarding.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_i
d=NTYyMg==

Notice regarding Processing of application for BA/BE permission

CDSCO issued notice on 21st Feb 2020 regarding Processing of application for BA/BE permission issued in Form CT-07
and Import License issued in Form CT-17 for Export. Permission to conduct BA/BE study of New Drugs for export
purposes is granted by Central Licensing Authority (CLA), as per the New Drugs and Clinical Trial Rules, 2019, in form
CT-07. Import License in form CT-17 is also granted for import of study drug for this purpose. In order to further
streamline the processing of such application, it has been decided that, such applications will be processed by CDSCO
within 15 working days of receipt of application.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_i
d=NTYxOQ==

Revised Guidance list of Laboratories on Performance Evaluation of In-vitro Diagnostic Medical Devices
CDSCO published Revised Guidance list of Laboratories on Performance Evaluation of In-vitro Diagnostic Medical
Devices on 24th Feb 2020. “In case of in-vitro diagnostic medical devices, performance evaluation report by the
manufacturer shall be submitted by the applicant. In this regard, SLA/ CLA may require the Performance Evaluation
Report for the in-vitro Diagnostics from laboratories.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_i
d=NTYzNg==
 Page No. 6

Regulation on Medical Device and In vitro Diagnostic manufacturing

By Pradeep Kumar Verma
1. Scope of the regulation—(1) These rules may be called the Medical Devices Rules, 2017, (2) these rules shall,
unless specified otherwise, come into force with effect from 1st day of January, 2018.

2. Application.— These rules shall be applicable in respect of,-

(i) Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical
sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-
clause (i);
(ii) Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants
and insecticides notified under sub-clause (ii); and
(iii) Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics
Act, 1940 (23 of 1940);

As per the Gazette Notification S.O 5980 (E ) dated 03.12.2018 stated that “ Nebulizer, Thermometer,
Glucometer and B.P meter regulate from 01.01.2020, continuously gazette notification issued by Ministry of
Health vide no. S.O 4671 (E ) dated 27.12.2019 stated that the word and figures 01 day of January 2020 the
word and figures 01 day of January 2021 shall be substituted of the notification S.O 5980 ( E) dated 03.12.2018.
As per the Gazette Notification S.O 775 (E ) dated 08.02.2019 stated that “(i) All implantable medical devices;
(ii) CT scan Equipment; (iii) MRI Equipment; (iv) Defibrillators; (v) Dialysis Machine; (vi) PET Equipment; (vii) X-
Ray Machine; and (viii) Bone marrow cell separator regulate from 01.04.2020, continuously gazette notification
issued by Ministry of Health vide no. S.O 4672 (E ) dated 27.12.2019 stated that the word and figures 01 day of
April 2020 the word and figures 01 day of January 2021 shall be substituted of the notification S.O 775 ( E) dated
08.02.2019.As per the Gazette Notification S.O 3721 dated 16.10.2019 Ultra Sound Machine will be regulate
from 01.11.2020
List of device currently in regulation

S. No Name of the device Date of notification

1 Disposable Hypodermic Syringes 17-03-1989
2 Disposable Hypodermic Needles 17-03-1989
3 Disposable Perfusion Sets 17-03-1989
4 In vitro Diagnostic Devices for HIV, HbsAg and HCV and blood grouping sera 27-08-2002
5 Cardiac Stents 06-10-2005
6 Drug Eluting Stents 06-10-2005
7 Catheters 06-10-2005
8 Intra Ocular Lenses 06-10-2005
9 I.V. Cannulae. 06-10-2005
 Page No. 7

S. No Name of the device Date of notification

10 Bone Cements 06-10-2005
11 Heart Valves 06-10-2005
12 Scalp Vein Set 06-10-2005
13 Orthopaedic Implants 06-10-2005
14 Internal Prosthetic Replacements 06-10-2005

15 Ablation Devices 25-01-2016

16 Sutures and Ligatures 01.01.2018
17 Disinfectants 01.01.2018

18 Blood Grouping Sera 01.01.2018

19 Surgical Dressing 01.01.2018

20 Umbilical Tapes 01.01.2018

21 Condoms 01.01.2018

22 Intra Uterine Devices 01.01.2018

23 Vaginal Tubal Rings 01.01.2018

24 Blood Bags 01.01.2018

25 All Implantable Devices Effective from 01.04.2021

26 MRI Effective from 01.04.2021

27 PET Effective from 01.04.2021

28 CT Scan Effective from 01.04.2021

29 X-Ray Effective from 01.04.2021
30 Ultrasound 01.11.2020
31 Dialyser Effective from 01.04.2021
32 Cell Separator Effective from 01.04.2021
33 Organ Preservative Solution 02.04.2019 (As Drugs)
34 Glucometer Effective from 01.01.2021
35 Nebulizer Effective from 01.01.2021
36 Blood Monitoring System Effective from 01.01.2021
37 Thermometer Effective from 01.01.2021
 Page No. 8

Regulation of Medical devices in India

The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services in Ministry of
Health and Family Welfare (MoHFW), Government of India (GoI) is the National Regulatory Authority (NRA) responsible
for approval of manufacturing, import, conduct of clinical trials, laying down standards, sale and distribution of medical
devices through enforcement and implementation of the Medical Devices Rules, 2017 released through Gazette of India
notification G.S.R. 78(E), dated 31st January 2017 by the MoHFW, GoI.
The Medical Devices Rules, 2017 contains rules on the following:
Chapter- I Title, Application, Commencement, Definition

Chapter - II Classification of MD, Grouping of MD, Essentials Principles

Chapter - III Authorities, delegation of powers, Notified bodies, Medical Devices Testing Centres,
Chapter - IV Manufacture of MD-Application, Inspection, grant of lic, conditions of lic, Suspension, Cancellation,
Appeal, Test License
Chapter - V Import of MD-Application, Overseas Inspection, grant of lic, Test lic, Hospital use, Personal use
Chapter - VI Labelling requirement
Chapter - VII Clinical Investigation- Permission, Medical management, Compensation, Inspection
Chapter - VIII Permission to import or manufacture medical device which does not have predicate medical device
Chapter -IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer and Notified Body
Chapter -X Regulation of Laboratories for carrying test or evaluation
Chapter - XI Sale of Medical Devices
Chapter - XII Miscellaneous – Rejection of application, Debarment of applicant, Exemptions

Medical Device Rules, 2017-Schedules

First Classification of MD and IVD

Second Fee
Third Registration and functions of Notified Bodies
Fourth Documents required for grant of mfg and Import licence
Fifth Quality Management System
Sixth Post Approval - Major and Minor Changes
Seventh Requirements to conduct Clinical Investigation
Eight Exemptions
 Page No.9

Roles and Responsibilities

Central Licensing Authority

The Drugs Controller General of India (DCGI) shall be the Central Licensing Authority, competent for the enforcement
of these rules in matters relating to,-
 import of all Classes of medical devices;
 manufacture of Class C and Class D medical devices;
 clinical investigation and approval of investigational medical devices;
 clinical performance evaluation and approval of new in vitro diagnostic medical devices and;
 Co-ordination with the State Licensing Authorities.
State Licensing Authority
The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent
authority for enforcement of these rules in matters relating to,-
 manufacture for sale or distribution of Class A or Class B medical devices;
 Sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
Delegation of powers of Licensing Authorities
(1) The Central Licensing Authority, may with the prior approval of the Central Government, by an order in writing,
delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organisation not below the
rank of Assistant Drugs Controller. (2) The officer to whom the powers have been delegated under sub-rule (1) shall
exercise the powers of the Central Licensing Authority under its name and seal.
(3) The State Licensing Authority, may, with the prior approval of the State Government, by an order in writing,
delegate all or any of its powers to any officer under its control.
(4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of the State
Licensing Authority under its name and seal.

Notified body.— (1) Any institute, organization or body corporate may seek accreditation, after notification of these
rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner
as may be determined by the National Accreditation Body from time to time.
(2) The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of
Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable
standards as specified under these rules in respect of such medical devices as and when so advised by the State
Licensing Authority.
(3) Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class
A or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority.
(4) Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing
Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it
has personnel with requisite qualification and experience.
 Page No.10

(5) With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make
an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with
a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule.
(6) The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate
in Form MD-2.
(7) The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or cancelled, provided the
registration certificate holder deposits a registration retention fee as specified in the Second Schedule every five years
from the date of its issue. (8) If the registration certificate holder fails to pay the required registration certificate retention
fee on or before due
date as referred to in sub-rule (7), the registration certificate holder shall, in addition to the retention fee, be liable to pay
a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part
thereof within ninety days, and in the event of non-payment of such fee during that period, the registration certificate
shall be deemed to have been cancelled.
(9) The Notified Body shall perform the functions as specified in Part II of the Third Schedule.
(10) The Central Licensing Authority, may, in cases where the requirement specified for registration of Notified Body have
not been complied with, reject the application and shall inform the applicant of the reasons for such rejection.
(11) An applicant who is aggrieved by the decision of the Central Licensing Authority under sub-rule (10), may file an
appeal within forty five days from the date of receipt of such rejection before the Central Government, which may after
such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of
sixty days.
Duties of Notified Body.— A registered Notified Body, referred to in rule 13, shall carry out its duties and functions, in
respect of Class A or Class B medical devices as specified in Part II of the Third Schedule.
Fees to be charged by Notified Body.— A registered Notified Body may charge fee from the applicant for the services
rendered by it as may be determined by the Central Government.
The notified bodies registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out audit of
manufacturing site under the provisions of said rules. In this connection, following Notified Bodies have been registered
with CDSCO vide letter no. 29/Misc/3/2017-DC (288) dated 30.12.2019:
1. M/s Intertek India Pvt. Ltd.
E-20, Block B1, Mohan Cooperative, Industrial Area New Delhi (India) - 110044 Telephone No.: 011-41595475,
9310412823 Fax: 011-41595460 E-Mail: kamal.gupta@intertek.com
2. M/s TUV Rheinland India Pvt. Ltd.
82/A West Wing, 3rd Main Road 82/A West Wing, 3rd Main Road Electronic City (India) - 560100 Telephone No.:
080- 46498030 Fax: 08046498042 E-Mail: guruprasad.hc@ind.tuv.com
3. M/s TUV Sud South Asia Pvt. Ltd.
TUV SUD House, Off Saki Vihar Road, Saki Naka Andheri (East), Mumbai-400072. Telephone No.: 022-49035508
Fax: 022-49035508 E-mail: info@tuv-sud.in
4. M/s, Dnv GI Business Assurance India Private Limited
Equinox Business Park, Tower 3, 6th Floor, BKC, LBS Road, Kurla West, Mumbai-400070 (India), Telephone No.:
022-61768909 Fax: 022-61768950 E-Mail: JOHER.JERWALLA@DNVGL.COM RC No. RC/NB-000004
 Page No.11

M/s, BSI Group India Pvt. Ltd.

5. The Mira Corporate Suites, Plot No. 1&2, lshwar Nagar, Delhi -110065 (India) Telephone No: 11-
26929000. Fax: 11-26929000 RC No. RC/NB-000005
6. M/s, BSCIC CERTIFICATIONS PVT. LTD.
Flat No. 6, Shiv Shakti, GH-15, Sec-21C, Part-3, Faridabad-121001 (India), Telephone No: 01294175513,
Fax: 01294175513 RC No. RC1NB-000006
7. M/s, TUV INTERCERT SAAR INDIA PRIVATE LIMITED
No 122/1, 3rd Main Road, Margosa Road, Malleswaram, Bangalore-560003 (India), Telephone No:
918041285610, Fax: 918041285610 RC No. RCIN B-000007
8. M/s, Zenith Quality Assessors Pvt. Ltd.
No. 306, 4’ Floor, Sai Apex, Viman Nagar, Pune-411014 (India), Telephone No: 20-41322042, 41322043,
Fax: 20-41322042, 41322043 RC No. RCINB-000008
Classification of medical devices & in vitro diagnostic medical devices
Medical devices and in-vitro diagnostic medical devices shall be classified on the basis of parameters specified in
section A below, in the following classes, namely:
(i) Low risk - Class A; (ii) Low moderate risk- Class B; (iii) Moderate high risk- Class C; (iv) High risk- Class D.
CDSCO has classified the many products as specified in letter 29/Misc/3/2017-DC (292) Date: 15.05.2019, if products
is not falls in classified list manufacturer / applicant will submit the application in CDSCO (HQ) w.r.t product
classification. Mainly form used in manufacturing of medical device and In-vitro diagnostic with mentioning the Fees
as specified in Schedule –II of MDR 2017
S.no Manufacturing Activity Form MD Fees (Rupees) Authority
1. Application for grant of license to Form One site -5000 Apply on
manufacture for sale or for distribution MD-3 Each distinct medical device - 500 CDSCO Sugam
for Class A or Class B medical device Portal

2. Application for grant of loan license to Form One site -5000 Apply on
manufacture for sale or for distribution MD-4 Each distinct medical device - 500 CDSCO Sugam
of Class A or Class B medical device Portal
3. Application for grant of license to Form One site -50000 Apply on
manufacture for sale or for MD7 Each distinct medical device - 1000 CDSCO Sugam
distribution of Class C or Class D Portal
medical devices
4. Application for grant of loan license to Form One site -50000 Apply on
manufacture for sale or for distribution MD8 Each distinct medical device - CDSCO Sugam
of Class C or Class D medical device 1000 Portal
5. Application for license to manufacture Form Each distinct medical device - 1000 Apply on
medical device for purpose of clinical MD12 CDSCO Sugam
investigations, test, evaluation, Portal
examination, demonstration, or training
 Page No.12

S.no Manufacturing Activity Form Fees (Rupees) Authority

MD
6. Application for grant of permission to Form 50000/- Apply on CDSCO
import/manufacture for sale or for distribution MD26 Sugam Portal
of medical device which does not have a
predicate medical device
7. Application for grant of permission to import or Form 25000/- Apply on CDSCO
manufacture for sale or for distribution of a MD28 Sugam Portal
New In-Vitro Diagnostic Medical Device
8. Licence to manufacture for sale or for Form As specified in applied Issued by SLA after
distribution of Class A or Class B Medical MD5 form MD audit by Notified
Device bodies

9. Loan Licence to manufacture for sale or for Form As specified in applied Issued by SLA
distribution of Class A or Class B Medical Device MD6 form MD
10. Licence to manufacture for sale or for Form As specified in applied Issued by CDSCO
distribution of Class C or Class D Medical MD9 form MD after inspection by
Device MDO

11. Loan Licence to manufacture for sale or for Form As specified in applied Issued by CDSCO
distribution of Class C or Class D Medical Device MD10 form MD
12 Licence to manufacture Medical Device for the Form As specified in applied Issued by CDSCO
purpose of clinical investigations or test or MD13 form MD
evaluation or demonstration or training

13. Permission to import/manufacture for sale or Form As specified in applied Issued by CDSCO
for distribution of medical device which does MD27 form MD
not have a predicate medical device

14. Permission to import or manufacture New In- Form As specified in applied Issued by CDSCO
Vitro Diagnostic Medical Device MD29 form MD

Manufacture of Medical Device for Sale or Distribution (Class A and B)

 Manufacturer shall apply through an identified online portal of Ministry with requisite documents as per Fourth
schedule and fees specified in Second schedule.
 No audit for class A device prior to grant of license.
 The audit may be carried out within 120 days from the date of issue of license.
 The audit for Class B device is necessary prior to the grant of manufacturing license and the audit shall be carried
out within 90 days from the date of application.
 The notified body shall furnish its report to SLA within 30 days.
 Page No.13

Manufacture of medical Device for Sale or Distribution (Class C and D)

 The application shall be made with requisite documents and fees through online portal of the Central
Government to CLA.
 CLA may use the services of any expert and of a notified body and may carry out an inspection within a period
of 60 days from the date of application.
 No inspection of a medical device manufacturing site for grant of loan license to be carried out if the site is
already licensed to manufacture such devices.
 After completion of inspection, the inspection team shall forward the report to CLA through online portal.

Standards of medical Devices

The medical device shall conform to the standards laid down by BIS or may be notified by Central Government from
time to time. If, such standards are not available then ISO, IEC or any other pharmacopoeial standard. If all are not
available then device shall conform to the validated manufacturer’s standard
Certification issuing Authority:-
1. (QMS) :- As per Medical Devices Rules, 2017, there is no mention of requirement for compliance to GMP, but
there is need for compliance to QMS and other rules. Therefore, now, there is no requirement of GMP
certificates for Medical Devices & IVDs, and the same certificate will issued by Concerned Licensing Authority
2. WHO GMP Certificate (Only request on behalf of Importing Country ) : Licensing Authority who has issued
the valid license to manufacture for sale will continue to issue WHO GMP certificate
3. Non-Conviction Certificate, Validity Certificate, Market Standing certificate:- Licensing Authority who has
issued license shall issue such certificates.
4. Free Sale Certificate: - Licensing Authority who has issued license shall issue such certificates.
 Page No. 14

Medical Device Testing Laboratories:-

Recently CDSCO has issued the Medical Device Testing Laboratories list
As Medical Devices Rules 2017 has already been published vide G.S.R. 78(E) dated 31.01.2017 under Drugs and
Cosmetics Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are
effective from 01.01.2018. The updated list of medical devices testing laboratories registered with CDSCO up till under
rule 81 in the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a medical device on behalf
of manufacturer is given below & there are more applicants which are under evaluation.
SL. NAME & ADDRESS REGISTRATION SCOPE OF TESTING
NO. OF MEDICAL DEVICE TESTING NO.
LABORATORY
1. M/s SIPRA LABS TL/MD/2019/0 1.Copper-T
LIMITED 00001 2. Condoms
Address: 7-2-181 3/5/A, Adj. To Post 3. Sterile Hypodermic Needles
Office, Industrial 4. TubaI Rings
Estate, Sanathnagar, Telangana, 5. Hypodermic Syringes
Hyderabad- 500018 6. Blood Bags
2. M/s Star Imaging & TL/MD/2019/0 1. Bilirubin (Total and Direct) Test
Path Lab Pvt. Ltd. 00002 Reagents / Kits
Address: 4B/4, Tilak Nagar , West Delhi, 2. Creatinine test reagent / kit
Delhi (India) - 110018 3. Aspartate Amino Transferase
(AST / SGOT) test
4. Alanine Amino Transferase
(ALT/SG PT) test
5. Uric Acid Test reagents / kits
6. Total Protein test reagents I kits
7. Activated partial thromboplastin time (APTT)
test,
8. PT (Prothromin Time) test Regeant kit
3. 3 M/s Alcatec Research TL/MD12019/0 1. Sterilized surgical ligatures
Laboratories India 00003 2. Sterilized Disposable Device
Pvt. Ltd. Address: 3.Sterilized Surgical Sutures
Part B, Haryana 1652 MIE
Bahadurgarh,- 124507
4. M/s Sree ChitraTirunal Institute For TL/MD/201 1.Cardio Vascular Devices(Biological Evaluation
Medical Sciences & 9/0 00004 as per ISO 10993) 2.NeuroprostheSiS (Biological
Technology Address: Medical Evaluation as per ISO 10993) 3. Orthopedic
College, Thiruvananthapuram, Implants (Biological Evaluation as per ISO 10993)
Kerala -695011 4. All medical devices and Materials (Biological
Evaluation as per ISO 10993)
5. Dental Implants (Biological Evaluation as per
ISO lO993)
 Page No.15

Global Regulatory at a glance

 USFDA: By Pranita Dhage
Novel coronavirus (COVID-19)
FDA is working with U.S. Government partners, including the U.S. Centers for Disease Control and Prevention (CDC),
and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in
Wuhan City, Hubei Province, China.While the U.S. Government considers this a serious public health concern, based
on current information, the immediate health risk from COVID-19 to the general American public is considered low
at this time.
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/novel-coronavirus-covid-19

Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA
The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy for novel coronavirus
(COVID-19) molecular diagnostics tests developed and used in laboratories certified to perform high-complexity
testing under the Clinical Laboratory Improvement Amendments (CLIA) prior to issuance of emergency use
authorizations (EUA) for such tests.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-
laboratories-certified-perform-high-complexity-testing-under-clia-prior

FDA approved Cannabis derived drug products

FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. The agency
has, however, approved one cannabis-derived drug product: Epidiolex (cannabidiol), and three synthetic cannabis-
related drug products: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). These approved drug
products are only available with a prescription from a licensed healthcare provider. Importantly, the FDA has not
approved any other cannabis, cannabis-derived, or cannabidiol (CBD) products currently available on the market.
https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process

 TGA
Application to reduce the deferral period for some blood donors under consideration

The TGA is evaluating an application submitted by Australian Red Cross Lifeblood, which proposes to reduce the
deferral period for donors with a sexual activity-based risk factor from 12 to three months since the last sexual
contact. This application follows a review initiated by Australian Red Cross Lifeblood in 2017.

The application is being evaluated by specialist scientific and medical evaluators within the TGA. As part of this
process, we may consider any advice and recommendations from the Advisory Committee on Biologicals to inform
the final TGA decision.

https://www.tga.gov.au/application-reduce-deferral-period-some-blood-donors-under-consideration
 Page No.16

 EMEA
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
 Two new medicines recommended for approval
The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) for the treatment of
infections due to aerobic Gram-negative organisms in adults with limited treatment options and the generic
medicine Tigecycline Accord (tigecycline) received a positive opinion for the treatment of complicated skin and soft
tissue (i.e. tissues just below the skin) infections and complicated intra-abdominal infections.

 Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of of indication for Alunbrig, Ofev and Otezla.The CHMP also
recommended the addition of a new pharmaceutical form for Entyvio: a 108 mg solution for injection to be given
subcutaneously.
 Negative opinion on extension of therapeutic indication-
The CHMP adopted a negative opinion for an extension of indication for Emgality (galcanezumab) to add
prevention of attacks in adults who suffer from episodic cluster headache.
 Start of referrals-
The CHMP started a review of medicines for which studies have been conducted by Panexcell Clinical
Laboratories Priv. Ltd at its site in Mumbai, India.

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-
chmp-24-27-february-2020
 ANVISA
CALL NOTICE NO. 2, OF JANUARY 29, 2020
ANVISA has defined a specific code for petitions related to call Notice 2/2020
On Thursday (1/30) Anvisa published call notice 2/2020, aimed at requesting information on similar drugs registered
in the country, but which have not yet been adapted to the rules of the collegiate board’s resolution (DRC) 134/2003.
RDC 134/2003 establishes standards for the suitability of similar drugs, requiring companies to send proof of safety
and efficacy or interchangeability with the reference drugs.

 NAFDAC
Public Alert No. 002/2020- Warning About ‘Life Threatening’ Side Effects Of ‘Miracle Mineral Solution
NAFDAC issued notice regarding Miracle Mineral Solution. It is described as a liquid that is 28 percent sodium chlorite
in distilled water. Product directions instruct people to mix the sodium chlorite solution with a citric acid, such as
lemon or lime juice, or another acid before drinking. The mixture becomes chlorine dioxide, a powerful bleaching
agent. Both sodium chlorite and chlorine dioxide are the active ingredients in disinfectants and have additional
industrial uses. They are not meant to be swallowed by people.
NAFDAC implores importers, distributors, retailers and consumers to immediately stop the importation, distribution,
sale and consumption of ‘Miracle Mineral Solution’
https://www.nafdac.gov.ng/public-alert-no-002-2020-warning-about-life-threatening-side-effects-of-miracle-
mineral-solution/

S.No. Drug Name
1 PIZENSY for oral
solution
2 NEXLETOL tablets, for
oral use
3 VYEPTI injection, for
Intravenous use
4 BARHEMSYS
5 NURTEC ODT
Reference – www.fda.org
Page No.17
US FDA New Drugs Approved in
February 2020
By Tausif Ahmad, RPh
Active ingredient Approved use Date of approval
Lactitol To treat chronic idiopathic 12-02-2020
constipation (CIC) in adults
Bempedoic acid To treat adults with heterozygous 21-02-2020
familial hypercholesterolemia or
established atherosclerotic
cardiovascular disease who
require additional lowering of
LDL-C
Eptinezumab-jjmr For the preventive treatment of 21-02-2020
migraine in adults
Amisulpride To help prevent nausea and 26-02-2020
vomiting after surgery
Rimegepant To treat migraine 27-02-2020
 Page No.18

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