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Swayam Central

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

By Prof. Aseem Sahu, Prof. Malay Mitra, Prof. Arun B.Ramteke   |   CDSCO,Ministry of Health & Family Welfare, Former DDC(I),CDSCO, Consultant Regulatory Affairs, CDSA, THSTI, DBT; Former Joint Drugs Controller, CDSCO
Medical devices and IVDs are an upcoming area and there are lots of new developments. It is important to know the right information as regulations can be misinterpreted. This knowledge when disseminated by the regulators themselves along with subject experts and experienced trainers, will have a profound impact. Being an online course will address a larger section of the public. Making it a ‘free course’ will allow many to acquire knowledge in the comfort of their home without paying any money. 

Demonstration of safety, efficacy, and performance of the medical device and in vitro diagnostic (IVD) kit 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 Rule 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 1.0) was attended by 657 participants (Jan - Mar 2019). 

A brainstorming series of discussions were steered by CDSA with CDSCO for incorporating the new updates. The feedback received from version 1.0 participants were 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 2.0. This now had 12 lectures spread over 4 weeks (online course). This will involve 4 weekly assignments and a final exit assessment. 4 new lectures have been added in version 2.0

INTENDED 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 : There is no pre-requisite to undertake this course.
INDUSTRY SUPPORT : Medical devices, IVD companies,Research/Academic Institutions, Biomedicalresearch organizations, Regulatory authorities, Medical colleges, Contract research organizations

Learners enrolled: 381

SUMMARY

Course Status : Upcoming
Course Type : Elective
Duration : 4 weeks
Start Date : 27 Jan 2020
End Date : 21 Feb 2020
Exam Date : 29 Mar 2020
Enrollment Ends : 03 Feb 2020
Category :
  • Multidisciplinary
  • Level : Undergraduate/Postgraduate
    This is an AICTE approved FDP course

    COURSE LAYOUT

    Week 1 :  Lecture 1: Introduction: Medical device and in vitro diagnostics Types of devices including combination devices and Drug Vs device Vs IVD
            Lecture 2: Medical Device Rules, 2017:  Implications on medical devices
              Lecture 3: Classification. Labeling of medical devices

    Week 2 :  Lecture 4:Standards of medical device, quality assurance, and testing
    Lecture 5: Biocompatibility studies on medical devices
    Lecture 6A: Clinical investigation of medical devices 

    Week 3 :  Lecture 7: Quality assurance and quality management system
    Lecture 8: Manufacture of medical devices and IVDs.How to obtain a license to manufacture a medical device?
    Lecture 9: Risk management system for medical devices (ISO 14971)

    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

    Drugs & Cosmetics Act and Rules, Medical Device Rules, 2017, Related Guidance documents available at CDSCO and ICMR websites.

    INSTRUCTOR BIO

    Prof. Aseem Sahu

    CDSCO,Ministry of Health & Family Welfare
    Shri. Aseem Sahu
    Deputy Drugs Controller (India), CDSCO 




    Prof. Malay Mitra

    Former DDC(I),CDSCO
    Shri. Mitra completed his Pharmaceutical education from Jadavpur University, Calcutta in 1974. He worked in the area of pharmaceutical manufacturing in various capacities up to 1982. He joined Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India in 1982. He has audited around 1500 institutions till date including China. He was an active member during the formation of Schedule M (GMP, Drugs and Cosmetic Rules, 1945). He was engaged in various workshops on Blood banking at Chandigarh, Lucknow, Delhi and was invited by the Government of Kerala to organize GMP seminars and training workshops in Cochin a number of times for their regulatory staff and manufacturers. More than 200 presentations on various technical topics have been delivered by him in various fora including the Indian Pharmaceutical Congress Association, Indian Pharmacy Graduates Association, Bureau of Indian Standards etc. He was a regulator visitor to NIPER, Mohali. He has been a member of the Indo-EU working group in Pharma & Biotech for 4 years. He was actively involved in the revision of the Cosmetics import regulations in India. He prepared the initial draft regulations for regulating Medical Devices under the Drugs & Cosmetic Rules. During his tenure heading the medical device division of CDSCO, he had made comprehensive strides in bringing about an understanding of medical device in his division and also had constant interaction with the stake holders to get a comprehensive idea of the issue of regulating medical devices. He represented the department (and the country) at the Asian Harmonisation Working Party (AHWP) meeting held at China to present the Indian point of view in medical device regulations. In 2008 he was instrumental in bringing the AHWP conference to India.He retired on superannuation as Deputy Drugs Controller (India) from the CDSCO Headquarters at New Delhi on the 31 st October 2011. His present area includes advising on Regulatory matters on manufacturing, import and research on pharmaceuticals, medical devices, cosmetics etc. He has assisted the Directorate General of Drugs Administration of Bangladesh in developing guidelines for Medical devices which has been published. He had also assisted PHARMEXCIL and Bureau of Indian Standards (as a working group member).


    Prof. Arun B.Ramteke

    Consultant Regulatory Affairs, CDSA, THSTI, DBT; Former Joint Drugs Controller, CDSCO
    Shri. Arunkumar B. Ramteke retired as a senior drugs regulatory officer (Joint Drugs Controller, India, CDSCO) with 31 years of experience in drug regulatory aspects in the office of the Drugs Controller General of India (DCGI). He has in-depth knowledge of Indian Drugs & Cosmetics Act, Rules and of regulations of Global Drug Regulatory norms. He started his career at Central Research Institute, Kasauli, as Deputy Assistant Director, BSQC Division and faculty for B.Sc. (Microbiology) H.P. University. As Drug Regulator he has extensive experience with new drugs, vaccines and biotech products/pharmaceuticals, medical devices regulatory approvals and development experience. He also has experience in review and evaluation of product dossier for pre-clinical, toxicological, pharmacological, CMC, and quality control, clinical trial data of new drugs, biological and medical devices (INDs, ANDAs). He has strong skills in quality assurance management, regulatory oversight of clinical trials, development of SOPs and guidelines and involvement in drug rules amendments. As an expert he has attended various national and international training workshops and meetings on drug regulations. He has contributed to preparation and implementation of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice. He works as an Expert to the Pharmacovigilance Program, GCP Training and Inspections of CROs in India. He has been working as Consultant and Faculty at Clinical Development Service Agency (CDSA), Department of Biotechnology, Govt. of India since April 2012. He is primarily involved in training workshops of GCP, Ethics Committee and other regulatory topics.

    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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