SlideShare a Scribd company logo
PREPARED BY :
Charmi Shah
(2308212170009)
RULES, SCHEDULE, GUIDELINES AND STANDARDS
FOR REGULATORY FILING OF MEDICAL DEVICES IN
INDIA
GUIDED BY:
Mrs. Lima Patel
Assistant professor
Parul Institute of Pharmacy
Contents :
Introduction
Classification of medical devices
Function of medical devices
Regulatory body for medical devices
Registration of medical devices
Constitution Of Medical Devices Technical Advisory Board
Group (MDTAG):
Manufacturing, import and export of medical
devices
Approval process
Clinical investigation
2
INTRODUCTION
• Devices intended for internal or external use in the diagnosis, treatment,
mitigation or prevention of disease in human beings or animals.
• It is an article, apparatus, instrument or machine that is used in the prevention,
diagnosis or treatment of illness or disease OR For detecting, measuring,
restoring, or modifying the structure/ function of the body for some health
purpose.
• "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.
3
• 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
• 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
5
Schedules: Medical Devices
• First Schedule – Parameters for classification of medical devices and in vitro
diagnostic medical devices
• Second Schedule – Fee payable for license, permission and registration certificate
• Third Schedule – Documents required for registration of Notified Body, its duties and
functions.
• Fourth Schedule – Documents required for grant of license to manufacture for sale or
for distribution or import
• Fifth Schedule – (QMS) Quality Management System for medical devices and in vitro
diagnostic medical devices
• Sixth Schedule – Post approval change
• Seventh Schedule – Requirements for permission to import or manufacture
investigational medical device for conducting clinical investigation
• Eight Schedule – Exemptions
6
List of Devices
CLASSIFICATION OF MEDICAL
DEVICES
Classification of medical device is based on risk factor.
1. Class A : Low Risk
• Bandages • Tongue depressors • Surgical dressing
2. Class B : Low- Moderate Risk
• Hypodermic Needles • Suction Equipment's
3. Class C : Moderate- High Risk
• Lung Ventilator • Bone fixation plate
4. Class D : High Risk
• Heart valves • Implantable defibrillator • Copper T
7
Functions of Medical Device division :
1) Grant of Certificate of Registration for a Notified Body for audit of Class A and
Class B Medical Devices
2) Grant of Import License
3) Grant of license or loan license to manufacture for sale or for distribution
4) Grant of test license to manufacture for test, evaluation, clinical investigations,
etc.
5) Grant of test license to import for test, evaluation, clinical investigations, etc.
6) Permission to conduct clinical investigation of Investigational Medical Device
7) Permission to conduct clinical performance evaluation for new in vitro diagnostic
medical device
8) Permission to import or manufacture new in vitro diagnostic medical device
9) Registration of Medical Device Testing Laboratory
8
10) Preparation of Guidance and FAQ on key activities
11) Updating the list as per the Classification of Medical Devices from time to time.
12) Preparing and submitting replies of Parliament Questions/Clarifications/NOCs/ Port
office queries
13) Providing clarification to applicant on the regulatory status of products.
9
REGULATORY BODY FOR MEDICAL DEVICES :
REGISTRATION:
• It is compulsory to obtain manufacturing and import licenses for all devices. All
the applications for manufacturing and import licenses are processed through an
online portal, SUGAM – which is an online licensing system that belongs to the
Ministry of Health and Family Welfare.
• For class A and B medical devices: Application for license or loan license to
manufacture made to the State Licensing Authority and it is granted or rejected
within 45 days from the date on which application made.
• For class C and D medical devices: Application to the Central Licensing
Authority
• A Quality Assessment Report (QAR) must be submitted for Class B, Class C, and
Class D devices, along with an application for a manufacturing license and a QAR
for Class A medical device needs to be submitted within 120 days from the date of
grant of Manufacturing License. 11
• In case of an Import License, a license for manufacturing or distribution is
necessary. Foreign manufacturers should appoint an authorized Indian agent to
hold the license and carry out post marketing surveillance (PMS) activities.
• In order to retain the license, person is required to pay license retention fee every
five years. The Indian government has made special note of the inevitability of
timelines, and rationalized the time required to grant a license.
12
CONSTITUTION OF MEDICAL DEVICES TECHNICAL
ADVISORY BOARD GROUP (MDTAG):
• It is to advice CDSCO related requirements of medical devices.
• The meeting of the board is called by Directorate General For International
Cooperation (DGIC)every 4 months.
Regulatory Body For Medical Devices consist of the following members :
• 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 13
MANUFACTURING:
New rules and regulations have been promoted by the authorities for manufacturing
medical devices in India.
• The licensing authorities for filing applications varies with the classification of
medical devices.
• Manufacturing of Class A and Class B medical devices will be granted licenses by the
State Licensing Authority.
• Whereas applications to manufacture Class C and Class D medical devices will be
reviewed and granted permission by the Central Licensing Authority.
• The application is granted provided that, no audit of site is required, or if required will
be carried out within 120 days from the date of grant.
• For class B before grant audit is required and that is to be carried out within 90 days
from the date of application.
o 14
• For the grant of license the manufacturing site should comply with QMS
requirements; appoint competent technical staff with educational qualification of
i) Degree in engineering (appropriate branch) or pharmacy or science (appropriate
subject) and experience of 2-3 years in manufacturing and testing of devices.
ii) Diploma in engineering or pharmacy with experience NLT 4 years in manufacturing
and testing of medical devices. License holder shall maintain audit or inspection book.
• License holder shall maintain an audit book.
• License holder have to maintain the records of quantity of pharmaceutical product
manufactured.
• CDSCO has also predefined appropriate application fees for different medical
devices.
• The application has to be accomplished with an undertaking stating the compliance
with the QMS.
15
16
IMPORT :
• When free sale certificate is issued by any other country, from which medical devices
are to be imported there is no need to carry out clinical investigation in importing
country e.g. India.
• In importing class A and class B medical devices from other countries published safety
and efficacy data or data from clinical investigation in the origin country will be
sufficient.
• When importing class C and class D devices from other countries clinical investigation
is required in India.
• The license holder have to report to the licensing authority if any action are taken by
the regulatory authority of origin country relating the observed ADR within 15 days.
• The importer is required to maintain record of name of manufacturer, quantity
imported and the date of import.
17
EXPORT :
• The certificate of quality, safety and performance of medical device is requested by
the exporter to the state licensing authority incase of class A and class B medical
devices whereas for class C and class D it is requested to central licensing authority.
• A “Certificate to export of each category of medical device” needs to be submitted
before any export processes.
18
19
20
Documents required for Registration of medical devices by the
Manufactures: -
1. Name & address of the company or firm or any other entity manufacturing the
medical device along with name and address of manufacturing site of medical
device.
2. Details of medical devices.
3. Certificate of compliance with respect to ISO 13485 standard
accredited by National Accreditation Board for Certification Bodies or
International Accreditation Forum in respect of such medical device.
4. undertaking duly signed by the manufacturer stating that the
information furnished by the applicant is true and authentic.
21
22
Documents required for Registration of Medical Devices by the
Importers: -
1. Name of the company or firm or any other entity importing the
medical device.
2. Details of medical device
3. Specification and standards of that medical device
4. certificate of compliance with respect to ISO 13485 standard accredited by National
Accreditation Board for Certification Bodies or International Accreditation Forum in
respect of such medical device.
5. Free sale certificate from country of origin
6.Undertaking duly signed by the importer stating that the information
furnished by the applicant is true and authentic.
CLINICAL INVESTIGATION:
• Class A and class B medical devices do not require a clinical investigation so, the
application for their manufacturing or import can be filed directly.
• Class C and class D medical devices require a clinical investigation to be conducted
due they have not been granted a free sale certificate by any of the GHTF countries
i.e US, Canada, EU, Japan and Australia.
• To conduct the clinical investigation, they have to take permission from central
licensing authority.
• There are two types of investigation:
1) Pilot clinical investigation: in human and in less population
2) Pivotal clinical investigation: in large population.
• The manufacturer is required to adhere to the Meteriovigilance Program of India
(MvPI) to keep track of medical device Serious Adverse Effects (SAEs )permission
to conduct the study approved or rejected within 90 days to application.
• Before starting an investigation, it has to be registered in Clinical Trial Registry of
India.
23
FORMS AND FEES :
24
25
Reference:
◦ https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Medical-Devices-
Rules/
◦ https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_de
vice/Medical%20Devices%20Rules,%202017.pdf
◦ https://www.ipc.gov.in/images/mvpi/Guidance_Document.pdf
◦ https://www.researchgate.net/publication/336879842_GUIDELINES_F
OR_MEDICAL_DEVICES_IN_INDIA
◦ https://sahpra.org.za/wp-
content/uploads/2020/01/Classification_Medical_Devices_IVDs_Nov1
9_v2.pdf
26
THANK YOU

More Related Content

What's hot

Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
CIRS China
 
Post Marketing Requirements/Complaince: PMRs and PMCs
Post Marketing Requirements/Complaince: PMRs and PMCsPost Marketing Requirements/Complaince: PMRs and PMCs
Post Marketing Requirements/Complaince: PMRs and PMCs
Dr. Reena Malik
 
Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India
RichaTrivedi16
 
Medical device clinical evaluation
Medical device clinical evaluationMedical device clinical evaluation
Medical device clinical evaluation
Malesh M
 
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATESQUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
vasanthi chodavarapu
 
Medical devices CHINA
Medical devices CHINA Medical devices CHINA
Medical devices CHINA
Parul Institute of Pharmacy
 
Medical device regulations in india
Medical device regulations in indiaMedical device regulations in india
Medical device regulations in india
Suraj Pamadi
 
20210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr202120210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr2021
Annet Visscher
 
Clinical Investigation of Medical devices and Clinical Investigation plan fo...
Clinical Investigation of Medical devices and  Clinical Investigation plan fo...Clinical Investigation of Medical devices and  Clinical Investigation plan fo...
Clinical Investigation of Medical devices and Clinical Investigation plan fo...
Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences
 
How to report an SAE
How to report an SAEHow to report an SAE
How to report an SAE
Dr. Shweta Bhatia
 
Computerized system validation
Computerized system validationComputerized system validation
Computerized system validation
Devipriya Viswambharan
 
21 CFR Part 11 checklist software.pptx
21 CFR Part 11 checklist software.pptx21 CFR Part 11 checklist software.pptx
21 CFR Part 11 checklist software.pptx
AartiVats5
 
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANMEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
DeveshDRA
 
Ich
IchIch
Doc in pharma
Doc in pharmaDoc in pharma
Doc in pharma
maitreyi zaveri
 
Ghtf study group 4
Ghtf study group 4Ghtf study group 4
Ghtf study group 4
sangeethapriyas3
 
The basics of medical device labeling usa fda regulations-by-costas-chantzis
The basics of medical device labeling   usa fda regulations-by-costas-chantzisThe basics of medical device labeling   usa fda regulations-by-costas-chantzis
The basics of medical device labeling usa fda regulations-by-costas-chantzis
Costas Chantzis
 
ISO 13485.pptx
ISO 13485.pptxISO 13485.pptx
ISO 13485.pptx
PrachiSharma575050
 
GMP for Nutraceuticals .pdf
GMP for Nutraceuticals  .pdfGMP for Nutraceuticals  .pdf
GMP for Nutraceuticals .pdf
BhavikaAPatel
 
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Swapnil Fernandes
 

What's hot (20)

Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
 
Post Marketing Requirements/Complaince: PMRs and PMCs
Post Marketing Requirements/Complaince: PMRs and PMCsPost Marketing Requirements/Complaince: PMRs and PMCs
Post Marketing Requirements/Complaince: PMRs and PMCs
 
Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India
 
Medical device clinical evaluation
Medical device clinical evaluationMedical device clinical evaluation
Medical device clinical evaluation
 
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATESQUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
 
Medical devices CHINA
Medical devices CHINA Medical devices CHINA
Medical devices CHINA
 
Medical device regulations in india
Medical device regulations in indiaMedical device regulations in india
Medical device regulations in india
 
20210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr202120210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr2021
 
Clinical Investigation of Medical devices and Clinical Investigation plan fo...
Clinical Investigation of Medical devices and  Clinical Investigation plan fo...Clinical Investigation of Medical devices and  Clinical Investigation plan fo...
Clinical Investigation of Medical devices and Clinical Investigation plan fo...
 
How to report an SAE
How to report an SAEHow to report an SAE
How to report an SAE
 
Computerized system validation
Computerized system validationComputerized system validation
Computerized system validation
 
21 CFR Part 11 checklist software.pptx
21 CFR Part 11 checklist software.pptx21 CFR Part 11 checklist software.pptx
21 CFR Part 11 checklist software.pptx
 
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANMEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
 
Ich
IchIch
Ich
 
Doc in pharma
Doc in pharmaDoc in pharma
Doc in pharma
 
Ghtf study group 4
Ghtf study group 4Ghtf study group 4
Ghtf study group 4
 
The basics of medical device labeling usa fda regulations-by-costas-chantzis
The basics of medical device labeling   usa fda regulations-by-costas-chantzisThe basics of medical device labeling   usa fda regulations-by-costas-chantzis
The basics of medical device labeling usa fda regulations-by-costas-chantzis
 
ISO 13485.pptx
ISO 13485.pptxISO 13485.pptx
ISO 13485.pptx
 
GMP for Nutraceuticals .pdf
GMP for Nutraceuticals  .pdfGMP for Nutraceuticals  .pdf
GMP for Nutraceuticals .pdf
 
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
 

Similar to rules, regulation and guideline for medical devices

Shruthi seminar final ppt (1)
Shruthi seminar final ppt (1)Shruthi seminar final ppt (1)
Shruthi seminar final ppt (1)
ShrutiGangurde1
 
Medical device regulations
Medical device regulationsMedical device regulations
Medical device regulations
garimasaini33
 
summary of indian medical device rule 2017
summary of  indian medical device rule 2017summary of  indian medical device rule 2017
summary of indian medical device rule 2017
Arshadib
 
Medical Device Registration in India
Medical Device Registration in India Medical Device Registration in India
Medical Device Registration in India
Chetan Umale
 
208_Regulation_of_medical_devices_in_India.ppt
208_Regulation_of_medical_devices_in_India.ppt208_Regulation_of_medical_devices_in_India.ppt
208_Regulation_of_medical_devices_in_India.ppt
VikramS58
 
medical device regulatory approval in USA
medical device regulatory approval in USAmedical device regulatory approval in USA
medical device regulatory approval in USA
Suraj Pamadi
 
Medical devices rules 2015 (summary)
Medical devices rules 2015 (summary)Medical devices rules 2015 (summary)
Medical devices rules 2015 (summary)
MUHAMMAD SOHAIL
 
Regulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devicesRegulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devices
Atul Bhombe
 
Malaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMalaysia Medical Devices Regulations
Malaysia Medical Devices Regulations
Mourad Kholti
 
Pharmaceutical Industry Development
Pharmaceutical Industry DevelopmentPharmaceutical Industry Development
Pharmaceutical Industry Development
RohitKoli27
 
Regulation for medical devices
Regulation for medical devicesRegulation for medical devices
Regulation for medical devices
BhagyalaxmiRanawat
 
Indian regulatory requirements - industrial pharmacy 2
Indian regulatory requirements - industrial pharmacy 2Indian regulatory requirements - industrial pharmacy 2
Indian regulatory requirements - industrial pharmacy 2
Jafarali Masi
 
Cdsco- a regulatory overview
Cdsco- a regulatory overviewCdsco- a regulatory overview
Cdsco- a regulatory overview
Vivekanandan S
 
India medical device regulatory process
India medical device regulatory processIndia medical device regulatory process
India medical device regulatory process
EMERGO
 
FDA regulation for medical devices
FDA regulation for medical devicesFDA regulation for medical devices
FDA regulation for medical devices
Simrana Fathima
 
Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.  Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.
KapilKumar198
 
Mdr 17 with 2020 rules
Mdr 17 with 2020 rulesMdr 17 with 2020 rules
Mdr 17 with 2020 rules
Prasad Bhat
 
Medical device regulation US, European Union and India
Medical device regulation  US, European Union and IndiaMedical device regulation  US, European Union and India
Medical device regulation US, European Union and India
CSIR-URDIP, NCL Campus, Pune
 
Medical Device Administration In China
Medical Device Administration In ChinaMedical Device Administration In China
Medical Device Administration In China
Jacobe2008
 
Drug approval process
Drug approval processDrug approval process
Drug approval process
LitashaGandhi
 

Similar to rules, regulation and guideline for medical devices (20)

Shruthi seminar final ppt (1)
Shruthi seminar final ppt (1)Shruthi seminar final ppt (1)
Shruthi seminar final ppt (1)
 
Medical device regulations
Medical device regulationsMedical device regulations
Medical device regulations
 
summary of indian medical device rule 2017
summary of  indian medical device rule 2017summary of  indian medical device rule 2017
summary of indian medical device rule 2017
 
Medical Device Registration in India
Medical Device Registration in India Medical Device Registration in India
Medical Device Registration in India
 
208_Regulation_of_medical_devices_in_India.ppt
208_Regulation_of_medical_devices_in_India.ppt208_Regulation_of_medical_devices_in_India.ppt
208_Regulation_of_medical_devices_in_India.ppt
 
medical device regulatory approval in USA
medical device regulatory approval in USAmedical device regulatory approval in USA
medical device regulatory approval in USA
 
Medical devices rules 2015 (summary)
Medical devices rules 2015 (summary)Medical devices rules 2015 (summary)
Medical devices rules 2015 (summary)
 
Regulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devicesRegulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devices
 
Malaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMalaysia Medical Devices Regulations
Malaysia Medical Devices Regulations
 
Pharmaceutical Industry Development
Pharmaceutical Industry DevelopmentPharmaceutical Industry Development
Pharmaceutical Industry Development
 
Regulation for medical devices
Regulation for medical devicesRegulation for medical devices
Regulation for medical devices
 
Indian regulatory requirements - industrial pharmacy 2
Indian regulatory requirements - industrial pharmacy 2Indian regulatory requirements - industrial pharmacy 2
Indian regulatory requirements - industrial pharmacy 2
 
Cdsco- a regulatory overview
Cdsco- a regulatory overviewCdsco- a regulatory overview
Cdsco- a regulatory overview
 
India medical device regulatory process
India medical device regulatory processIndia medical device regulatory process
India medical device regulatory process
 
FDA regulation for medical devices
FDA regulation for medical devicesFDA regulation for medical devices
FDA regulation for medical devices
 
Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.  Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.
 
Mdr 17 with 2020 rules
Mdr 17 with 2020 rulesMdr 17 with 2020 rules
Mdr 17 with 2020 rules
 
Medical device regulation US, European Union and India
Medical device regulation  US, European Union and IndiaMedical device regulation  US, European Union and India
Medical device regulation US, European Union and India
 
Medical Device Administration In China
Medical Device Administration In ChinaMedical Device Administration In China
Medical Device Administration In China
 
Drug approval process
Drug approval processDrug approval process
Drug approval process
 

More from Charmi13

Legislation And Regulations For Import, Manufacture,.pptx
Legislation And Regulations For Import, Manufacture,.pptxLegislation And Regulations For Import, Manufacture,.pptx
Legislation And Regulations For Import, Manufacture,.pptx
Charmi13
 
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPEACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
Charmi13
 
different biological product and difference between biosimilllar and generic
different biological product and difference between biosimilllar and genericdifferent biological product and difference between biosimilllar and generic
different biological product and difference between biosimilllar and generic
Charmi13
 
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval  changes for RA 1st sempptxSUPAC(Scale Up and Post Approval  changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
Charmi13
 
E4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
E4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATIONE4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
E4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
Charmi13
 
Quality by design.. ppt for RA (1ST SEM
Quality by design.. ppt for  RA (1ST SEMQuality by design.. ppt for  RA (1ST SEM
Quality by design.. ppt for RA (1ST SEM
Charmi13
 

More from Charmi13 (6)

Legislation And Regulations For Import, Manufacture,.pptx
Legislation And Regulations For Import, Manufacture,.pptxLegislation And Regulations For Import, Manufacture,.pptx
Legislation And Regulations For Import, Manufacture,.pptx
 
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPEACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
 
different biological product and difference between biosimilllar and generic
different biological product and difference between biosimilllar and genericdifferent biological product and difference between biosimilllar and generic
different biological product and difference between biosimilllar and generic
 
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval  changes for RA 1st sempptxSUPAC(Scale Up and Post Approval  changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
 
E4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
E4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATIONE4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
E4 GUIDELINE DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
 
Quality by design.. ppt for RA (1ST SEM
Quality by design.. ppt for  RA (1ST SEMQuality by design.. ppt for  RA (1ST SEM
Quality by design.. ppt for RA (1ST SEM
 

Recently uploaded

Cardiac Assessment for B.sc Nursing Student.pdf
Cardiac Assessment for B.sc Nursing Student.pdfCardiac Assessment for B.sc Nursing Student.pdf
Cardiac Assessment for B.sc Nursing Student.pdf
shivalingatalekar1
 
share - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptxshare - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
Tina Purnat
 
CHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdfCHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdf
rishi2789
 
Histololgy of Female Reproductive System.pptx
Histololgy of Female Reproductive System.pptxHistololgy of Female Reproductive System.pptx
Histololgy of Female Reproductive System.pptx
AyeshaZaid1
 
Pharmacology of 5-hydroxytryptamine and Antagonist
Pharmacology of 5-hydroxytryptamine and AntagonistPharmacology of 5-hydroxytryptamine and Antagonist
Pharmacology of 5-hydroxytryptamine and Antagonist
Dr. Nikhilkumar Sakle
 
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptxREGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
LaniyaNasrink
 
NARCOTICS- POLICY AND PROCEDURES FOR ITS USE
NARCOTICS- POLICY AND PROCEDURES FOR ITS USENARCOTICS- POLICY AND PROCEDURES FOR ITS USE
NARCOTICS- POLICY AND PROCEDURES FOR ITS USE
Dr. Ahana Haroon
 
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptxPost-Menstrual Smell- When to Suspect Vaginitis.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
FFragrant
 
CHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdfCHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdf
rishi2789
 
Abortion PG Seminar Power point presentation
Abortion PG Seminar Power point presentationAbortion PG Seminar Power point presentation
Abortion PG Seminar Power point presentation
AksshayaRajanbabu
 
Complementary feeding in infant IAP PROTOCOLS
Complementary feeding in infant IAP PROTOCOLSComplementary feeding in infant IAP PROTOCOLS
Complementary feeding in infant IAP PROTOCOLS
chiranthgowda16
 
Travel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff: Health Advice for International TravelersTravel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff: Health Advice for International Travelers
NX Healthcare
 
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptxEar and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Dr. Rabia Inam Gandapore
 
Cervical Disc Arthroplasty ORSI 2024.pptx
Cervical Disc Arthroplasty ORSI 2024.pptxCervical Disc Arthroplasty ORSI 2024.pptx
Cervical Disc Arthroplasty ORSI 2024.pptx
LEFLOT Jean-Louis
 
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdfCHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
rishi2789
 
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune DiseaseCell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
Health Advances
 
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptxVestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Dr. Rabia Inam Gandapore
 
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
FFragrant
 
DECLARATION OF HELSINKI - History and principles
DECLARATION OF HELSINKI - History and principlesDECLARATION OF HELSINKI - History and principles
DECLARATION OF HELSINKI - History and principles
anaghabharat01
 
Physical demands in sports - WCSPT Oslo 2024
Physical demands in sports - WCSPT Oslo 2024Physical demands in sports - WCSPT Oslo 2024
Physical demands in sports - WCSPT Oslo 2024
Torstein Dalen-Lorentsen
 

Recently uploaded (20)

Cardiac Assessment for B.sc Nursing Student.pdf
Cardiac Assessment for B.sc Nursing Student.pdfCardiac Assessment for B.sc Nursing Student.pdf
Cardiac Assessment for B.sc Nursing Student.pdf
 
share - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptxshare - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
 
CHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdfCHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 1_ANTI TB DRUGS.pdf
 
Histololgy of Female Reproductive System.pptx
Histololgy of Female Reproductive System.pptxHistololgy of Female Reproductive System.pptx
Histololgy of Female Reproductive System.pptx
 
Pharmacology of 5-hydroxytryptamine and Antagonist
Pharmacology of 5-hydroxytryptamine and AntagonistPharmacology of 5-hydroxytryptamine and Antagonist
Pharmacology of 5-hydroxytryptamine and Antagonist
 
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptxREGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
 
NARCOTICS- POLICY AND PROCEDURES FOR ITS USE
NARCOTICS- POLICY AND PROCEDURES FOR ITS USENARCOTICS- POLICY AND PROCEDURES FOR ITS USE
NARCOTICS- POLICY AND PROCEDURES FOR ITS USE
 
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptxPost-Menstrual Smell- When to Suspect Vaginitis.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
 
CHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdfCHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdf
CHEMOTHERAPY_RDP_CHAPTER 4_ANTI VIRAL DRUGS.pdf
 
Abortion PG Seminar Power point presentation
Abortion PG Seminar Power point presentationAbortion PG Seminar Power point presentation
Abortion PG Seminar Power point presentation
 
Complementary feeding in infant IAP PROTOCOLS
Complementary feeding in infant IAP PROTOCOLSComplementary feeding in infant IAP PROTOCOLS
Complementary feeding in infant IAP PROTOCOLS
 
Travel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff: Health Advice for International TravelersTravel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff: Health Advice for International Travelers
 
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptxEar and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
 
Cervical Disc Arthroplasty ORSI 2024.pptx
Cervical Disc Arthroplasty ORSI 2024.pptxCervical Disc Arthroplasty ORSI 2024.pptx
Cervical Disc Arthroplasty ORSI 2024.pptx
 
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdfCHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
 
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune DiseaseCell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
 
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptxVestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
 
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
 
DECLARATION OF HELSINKI - History and principles
DECLARATION OF HELSINKI - History and principlesDECLARATION OF HELSINKI - History and principles
DECLARATION OF HELSINKI - History and principles
 
Physical demands in sports - WCSPT Oslo 2024
Physical demands in sports - WCSPT Oslo 2024Physical demands in sports - WCSPT Oslo 2024
Physical demands in sports - WCSPT Oslo 2024
 

rules, regulation and guideline for medical devices

  • 1. PREPARED BY : Charmi Shah (2308212170009) RULES, SCHEDULE, GUIDELINES AND STANDARDS FOR REGULATORY FILING OF MEDICAL DEVICES IN INDIA GUIDED BY: Mrs. Lima Patel Assistant professor Parul Institute of Pharmacy
  • 2. Contents : Introduction Classification of medical devices Function of medical devices Regulatory body for medical devices Registration of medical devices Constitution Of Medical Devices Technical Advisory Board Group (MDTAG): Manufacturing, import and export of medical devices Approval process Clinical investigation 2
  • 3. INTRODUCTION • Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease in human beings or animals. • It is an article, apparatus, instrument or machine that is used in the prevention, diagnosis or treatment of illness or disease OR For detecting, measuring, restoring, or modifying the structure/ function of the body for some health purpose. • "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. 3
  • 4. • 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 • 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
  • 5. 5 Schedules: Medical Devices • First Schedule – Parameters for classification of medical devices and in vitro diagnostic medical devices • Second Schedule – Fee payable for license, permission and registration certificate • Third Schedule – Documents required for registration of Notified Body, its duties and functions. • Fourth Schedule – Documents required for grant of license to manufacture for sale or for distribution or import • Fifth Schedule – (QMS) Quality Management System for medical devices and in vitro diagnostic medical devices • Sixth Schedule – Post approval change • Seventh Schedule – Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation • Eight Schedule – Exemptions
  • 7. CLASSIFICATION OF MEDICAL DEVICES Classification of medical device is based on risk factor. 1. Class A : Low Risk • Bandages • Tongue depressors • Surgical dressing 2. Class B : Low- Moderate Risk • Hypodermic Needles • Suction Equipment's 3. Class C : Moderate- High Risk • Lung Ventilator • Bone fixation plate 4. Class D : High Risk • Heart valves • Implantable defibrillator • Copper T 7
  • 8. Functions of Medical Device division : 1) Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices 2) Grant of Import License 3) Grant of license or loan license to manufacture for sale or for distribution 4) Grant of test license to manufacture for test, evaluation, clinical investigations, etc. 5) Grant of test license to import for test, evaluation, clinical investigations, etc. 6) Permission to conduct clinical investigation of Investigational Medical Device 7) Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device 8) Permission to import or manufacture new in vitro diagnostic medical device 9) Registration of Medical Device Testing Laboratory 8
  • 9. 10) Preparation of Guidance and FAQ on key activities 11) Updating the list as per the Classification of Medical Devices from time to time. 12) Preparing and submitting replies of Parliament Questions/Clarifications/NOCs/ Port office queries 13) Providing clarification to applicant on the regulatory status of products. 9
  • 10. REGULATORY BODY FOR MEDICAL DEVICES :
  • 11. REGISTRATION: • It is compulsory to obtain manufacturing and import licenses for all devices. All the applications for manufacturing and import licenses are processed through an online portal, SUGAM – which is an online licensing system that belongs to the Ministry of Health and Family Welfare. • For class A and B medical devices: Application for license or loan license to manufacture made to the State Licensing Authority and it is granted or rejected within 45 days from the date on which application made. • For class C and D medical devices: Application to the Central Licensing Authority • A Quality Assessment Report (QAR) must be submitted for Class B, Class C, and Class D devices, along with an application for a manufacturing license and a QAR for Class A medical device needs to be submitted within 120 days from the date of grant of Manufacturing License. 11
  • 12. • In case of an Import License, a license for manufacturing or distribution is necessary. Foreign manufacturers should appoint an authorized Indian agent to hold the license and carry out post marketing surveillance (PMS) activities. • In order to retain the license, person is required to pay license retention fee every five years. The Indian government has made special note of the inevitability of timelines, and rationalized the time required to grant a license. 12
  • 13. CONSTITUTION OF MEDICAL DEVICES TECHNICAL ADVISORY BOARD GROUP (MDTAG): • It is to advice CDSCO related requirements of medical devices. • The meeting of the board is called by Directorate General For International Cooperation (DGIC)every 4 months. Regulatory Body For Medical Devices consist of the following members : • 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 13
  • 14. MANUFACTURING: New rules and regulations have been promoted by the authorities for manufacturing medical devices in India. • The licensing authorities for filing applications varies with the classification of medical devices. • Manufacturing of Class A and Class B medical devices will be granted licenses by the State Licensing Authority. • Whereas applications to manufacture Class C and Class D medical devices will be reviewed and granted permission by the Central Licensing Authority. • The application is granted provided that, no audit of site is required, or if required will be carried out within 120 days from the date of grant. • For class B before grant audit is required and that is to be carried out within 90 days from the date of application. o 14
  • 15. • For the grant of license the manufacturing site should comply with QMS requirements; appoint competent technical staff with educational qualification of i) Degree in engineering (appropriate branch) or pharmacy or science (appropriate subject) and experience of 2-3 years in manufacturing and testing of devices. ii) Diploma in engineering or pharmacy with experience NLT 4 years in manufacturing and testing of medical devices. License holder shall maintain audit or inspection book. • License holder shall maintain an audit book. • License holder have to maintain the records of quantity of pharmaceutical product manufactured. • CDSCO has also predefined appropriate application fees for different medical devices. • The application has to be accomplished with an undertaking stating the compliance with the QMS. 15
  • 16. 16
  • 17. IMPORT : • When free sale certificate is issued by any other country, from which medical devices are to be imported there is no need to carry out clinical investigation in importing country e.g. India. • In importing class A and class B medical devices from other countries published safety and efficacy data or data from clinical investigation in the origin country will be sufficient. • When importing class C and class D devices from other countries clinical investigation is required in India. • The license holder have to report to the licensing authority if any action are taken by the regulatory authority of origin country relating the observed ADR within 15 days. • The importer is required to maintain record of name of manufacturer, quantity imported and the date of import. 17
  • 18. EXPORT : • The certificate of quality, safety and performance of medical device is requested by the exporter to the state licensing authority incase of class A and class B medical devices whereas for class C and class D it is requested to central licensing authority. • A “Certificate to export of each category of medical device” needs to be submitted before any export processes. 18
  • 19. 19
  • 20. 20
  • 21. Documents required for Registration of medical devices by the Manufactures: - 1. Name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device. 2. Details of medical devices. 3. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device. 4. undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic. 21
  • 22. 22 Documents required for Registration of Medical Devices by the Importers: - 1. Name of the company or firm or any other entity importing the medical device. 2. Details of medical device 3. Specification and standards of that medical device 4. certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device. 5. Free sale certificate from country of origin 6.Undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.
  • 23. CLINICAL INVESTIGATION: • Class A and class B medical devices do not require a clinical investigation so, the application for their manufacturing or import can be filed directly. • Class C and class D medical devices require a clinical investigation to be conducted due they have not been granted a free sale certificate by any of the GHTF countries i.e US, Canada, EU, Japan and Australia. • To conduct the clinical investigation, they have to take permission from central licensing authority. • There are two types of investigation: 1) Pilot clinical investigation: in human and in less population 2) Pivotal clinical investigation: in large population. • The manufacturer is required to adhere to the Meteriovigilance Program of India (MvPI) to keep track of medical device Serious Adverse Effects (SAEs )permission to conduct the study approved or rejected within 90 days to application. • Before starting an investigation, it has to be registered in Clinical Trial Registry of India. 23
  • 25. 25
  • 26. Reference: ◦ https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Medical-Devices- Rules/ ◦ https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_de vice/Medical%20Devices%20Rules,%202017.pdf ◦ https://www.ipc.gov.in/images/mvpi/Guidance_Document.pdf ◦ https://www.researchgate.net/publication/336879842_GUIDELINES_F OR_MEDICAL_DEVICES_IN_INDIA ◦ https://sahpra.org.za/wp- content/uploads/2020/01/Classification_Medical_Devices_IVDs_Nov1 9_v2.pdf 26