Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)

By Shri Aseem Sahu, Shri. Malay Mitra | CDSCO,Ministry of Health & Family Welfare Former DDC(I),CDSCO CDSA,THSTI,DBT

Learners enrolled: 2078

The course is developed by Clinical Development Services Agency (CDSA) in partnership with the Central Drugs Standard Control Organisation (CDSCO). The course is developed with NPTEL.

CDSA is an extramural unit of the Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India. CDSA has a national mandate to enhance the capacity and capability of clinical development in India.

CDSCO is the National Regulatory Authority (NRA) of India. It is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO along with the state regulators are jointly responsible for grant of licenses of certain specialized categories of critical drugs such as blood and blood products, intravenous fluids, vaccines, and sera.

Demonstration of safety, efficacy, and performance of the medical device and in vitro diagnostic (IVD) for use in humans is essential before the product can be approved for import or manufacture and marketing in the country. Medical devices are currently regulated under the definition of ‘drug’. Recent amendments made in the Rules by incorporating specific rules i.e. “Medical Devices Rules 2017’’ [G.S.R. 78 (E) dated the 31st January 2017] are published and are mandatory with effect from 1st January 2018. These Rules provided requirements for import, manufacture, clinical investigation, medical device and in vitro diagnostics. All these had been effectively addressed in this course launched in early 2019 with 10 lectures as a four-week course. This online course (version 1) was attended by 657 participants (Jan - Mar 2019).

A series of brainstorming sessions were conducted by CDSA with CDSCO for incorporating the new updates. The feedback received from the earlier version of this course was sought. Also, the deliberations from various face-to-face programs on medical devices and IVDs that were conducted by CDSA and CDSCO were incorporated to decide the content for version 2. This course consists of 12 lectures spread over 4 weeks with 4 weekly assignments and a final exit assessment. Only those wishing to undertake the certification exams (which requires payment of a fee) need to opt for the latter. This online course is free. The exam is optional for a fee.

COURSE OBJECTIVES AND EXPECTED LEARNING OUTCOME

Upon completion of this online course successfully, the participants will understand:

Medical device and in vitro diagnostic (IVD), classification and types of medical devices.
Medical device and testing, personnel involved, quality assurance, quality management
system.
Biocompatibility studies, clinical investigation, risk management, international practices.
Manufacturing license, inspection, fees, import, export, etc.

TARGET AUDIENCE :

Medical device industry
in vitro diagnostics (IVD) manufacturers
Innovators or start-ups involved in either medical device or IVDs
Regulatory affairs personnel
Human ethics committee members
Clinical trial/research team members
Any person interested to acquire knowledge in this area

PRE-REQUISITES :

Indian nationals working in this area of medical devices and IVDs are encouraged to undertake this online course. There is no pre-requisite to undertake this course.

INDUSTRY THAT WILL VALUE THE COURSE:

Medical devices, IVD companies, research/academic institutions, biomedical research organizations, regulatory authorities, medical colleges, contract research organizations

Summary

Course Status :	Completed
Course Type :	Elective
Language for course content :	English
Duration :	4 weeks
Category :	Multidisciplinary
Credit Points :	1
Level :	Undergraduate/Postgraduate
Start Date :	27 Jan 2020
End Date :	21 Feb 2020
Enrollment Ends :	03 Feb 2020
Exam Date :	29 Mar 2020 IST

Note: This exam date is subject to change based on seat availability. You can check final exam date on your hall ticket.

Page Visits

Course layout

Week 1: Lecture 0: Course overview
Lecture 1: Medical device and in vitro diagnostics: Introduction and types of devices including combination devices

Lecture 2: Medical Device Rules, 2017: Implications on medical device

Lecture 3A: Classification of medical devices

Lecture 3B: Labelling of medical devices and in vitro diagnostics

Week 2 : Lecture 4: Standards of medical device, quality assurance, and testing

Lecture 5: Regulatory requirements of biocompatibility of medical devices and ISO 10993

Lecture 6: Clinical investigation of medical devices: regulation of investigational medical devices

Week 3 : Lecture 7: Quality assurance and quality management system

Lecture 8: How to obtain a licence to manufacture a medical device?

Lecture 9: ISO 14971 (Medical devices: Application of risk management to medical devices)

Week 4 : Lecture 10: Inspection of medical device and IVD establishments

Lecture 11: Import and export of medical devices and IVDs

Lecture 12: Medical device regulation: International practices

Books and references

Medical Devices Rules, 2017, Related Guidance documents available at CDSCO websites.

Instructor bio

1. Shri Aseem Sahu, Deputy Drugs Controller (India), Central Drugs Standard Control Organisation (CDSCO)

2. Shri. Malay Mitra, Former Deputy Drugs Controller (India), Central Drugs Standard Control Organisation (CDSCO)

1) COURSE DEVELOPMENT TEAM :

1. Dr. Sucheta Banerjee Kurundkar, Director Training, CDSA, THSTI, DBT

2. Shri Arun Kumar B. Ramteke, Former Joint Drugs Controller (India), CDSCO; Consultant, Regulatory Affairs, CDSA, THSTI, DBT

3. Dr. Nitya Wadhwa, Assistant Professor, THSTI and Faculty In-Charge, CDSA, THSTI, DBT

4. Professor Usha Menon, Strategy Lead, Adjunct Professor CDSA, THSTI, DBT, Professor MRC CTU at University College London

2) TEACHING ASSISTANCE :

1. Ms. Vandana Chawla, Training Manager, CDSA, THSTI, DBT

2. Mr Jitender Ahuja, Training Coordinator, CDSA, THSTI, DBT

3) TECHNICAL ASSISTANCE :

1. Mr Taneja, IIT Delhi

Course certificate

• The course is free to enroll and learn from. But if you want a certificate, you have to register and write the proctored exam conducted by us in person at any of the designated exam centres.
• The exam is optional for a fee of Rs 1000/- (Rupees one thousand only).
• Date and Time of Exams: 29th March 2020, Morning session 9am to 12 noon; Afternoon Session 2pm to 5pm.
• Registration url: Announcements will be made when the registration form is open for registrations.
• The online registration form has to be filled and the certification exam fee needs to be paid. More details will be made available when the exam registration form is published. If there are any changes, it will be mentioned then.
• Please check the form for more details on the cities where the exams will be held, the conditions you agree to when you fill the form etc.

CRITERIA TO GET A CERTIFICATE:
• Average assignment score = 25% of average of best 3 assignments out of the total 4 assignments given in the course.
• Exam score = 75% of the proctored certification exam score out of 100
• Final score = Average assignment score + Exam score

YOU WILL BE ELIGIBLE FOR A CERTIFICATE ONLY IF AVERAGE ASSIGNMENT SCORE >=10/25 AND EXAM SCORE >= 30/75.
• If one of the 2 criteria is not met, you will not get the certificate even if the Final score >= 40/100.
• Certificate will have your name, photograph and the score in the final exam with the breakup.It will have the logos of NPTEL and IIT Madras. It will be e-verifiable at nptel.ac.in/noc.
• Only the e-certificate will be made available. Hard copies will not be dispatched.

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