Post Graduate Diploma/Executive Diploma in Regulatory Affairs (Medical Device as Major) (PGDRAMDM/EDRAMDM)

Before a drug or a medical device can enter any market, it needs to fulfill all the applicable regulatory requirements and gain approval from the concerned regulatory bodies. Regulatory and demographic environment is a part of challenge to the pharmaceutical and the medical device industry. The real struggle is to define the strategy, development of appropriate business plan and efficient execution of the same. For that technical expertise is required. All employees should be aware of the expectations and procedures within the company. Assessment of employees is done on the basis of their knowledge and skill.

IGMPI offers Post Graduate Diploma/Executive Diploma in Regulatory Affairs with the major area of thrust being the regulatory scenario for Medical Devices. The curriculum is designed and developed by experts from the medical device regulatory industry and is focused on both theoretical and practical aspects. The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates willing to enter this exciting field of liaison between the technical aspects of a medical device as well as the legal role of submissions and approvals.

IGMPI offers an opportunity for everyone to come and learn with us the intricacies of this exciting career choice and be a very good professional at it through the learning acquired here.

Module 1: Introduction to Global Regulatory Authorities for Medical Device Industry

Module 2: Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module

Module 3: FDA Regulations and Guidelines on Medical Devices

Module 4: European Union Regulatory Guidelines on Medical Devices (Part 1 and Part 2)

Module 5: Medical Device Regulations from Indian perspective

Module 6: Management of the risks associated with Medical devices

Module 7: Biocompatibility Studies and Medical Devices

Module 8: Clinical Trials: Medical Devices

Module 9: Materiovigilance across the Globe

Module 10: Overview of In – Vitro Device Regulation

Module 11: Overview of Combination Products Regulation

Module 12: Medical Device Registration, e-Submissions and Approvals in US, Europe and India

Module 13: Capstone Project

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certifications Programmes. 10+2 pass-outs are eligible for our Under Graduate Diploma and Diploma holders of two to three years course duration are also eligible for the PG Diploma.

Programme Duration

The minimum duration to complete the PG diploma programme is 12 months and maximum is 24 months. The minimum duration to complete the executive diploma programme is 6 months and maximum is 12 months.

Programme Mode

Registrations are currently open for regular and Part-time (Online Live Classes) both modes.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online Live Classes/Part-time for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Regulatory Affairs Medical Device as Major by IGMPI. For all the above-mentioned modules, Online Live Classes/Part-time or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Discipline in Classes and Examination

Every student is required to observe a disciplined behaviour during her/his classes, assessments & examinations and to follow instructions from the Professors. Any act of indiscipline may result into discredit & it will be mentioned in her/his academic report.

Placement Assistance & Corporate Relations

For the Post Graduate Diploma and Undergraduate Diploma Programmes, we will provide placement assistance after the completion of the programme. The Institute has partnered with many organizations for providing placement assistance to its students. The robust placement cell comprises senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like , Jhpiego, SELCO Foundation, TATA Foundation, Samarthan NGO, PSI, UNICEF, WHO, HCL Foundation, IPE Global, Optum, PATH, AIIMS, Action against Hunger, Ekta Shakti Foundation, Seva Foundation, India HIV-AIDS Alliance, HLFPPT, Deepak Foundation, Novartis, LalPath Labs Ltd., Fortis Healthcare Ltd., HealthCare Global Enterprises Ltd., Indraprastha Medical Corporation Ltd., Narayana Hrudayalaya Ltd., Piramal Enterprises Ltd., Wockhardt Ltd., Cactus Communications, Public Health Foundations of India, Cytel, Religare Health Insurance Company Ltd., Deloitte, DuPont Sustainable Solutions, Bain & Company, Alvarez & Marsal, McKinsey & Company, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future and career prospects

Medical Devices Industry is highly alluring sector now a days. Hence, there is fierce competition in this sector. Proper training and knowledge in this field is required so as to reach the pinnacle of success in this particular sector.

Professional and industry oriented training programmes such as Medical Device Management by IGMPI, open doors for entry into the industry. Post Graduate Diploma/Executive Diploma in Regulatory Affairs (Medical Device as Major) is a broad spectrum programme which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry. After the completion of this programme the candidate gets selected in industry/sector of his/her interest. This programme is also beneficial for working professionals to gain hike in their sector by getting updated knowledge of the field.

View Prospectus

Apply Online

Last date for submitting completed Application Form: 10^th Aug 2026.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in