Institute of Good Manufacturing Practices India®

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IGMPI Approvals & Accreditation : Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India, Approved Training Institute of Food Safety and Standards Authority of India (FSSAI), Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh, Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC)
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Certified Medical Device Regulatory Affairs Professional

Medical device industry is one of the rapidly growing industries in healthcare, driven by innovation and new technologies. The last few years have seen an unprecedented growth in innovative and improved technologies, which has led to the development of state-of-the-art medical devices and catalyzed growth and advancement in the healthcare industry.

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. IGMPI offers this certified course to understand 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. This course gives maximum coverage of the foundations of the medical devices regulations and their application in the medical device market today and near future.

This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration.


1. Introduction to Global Regulatory Authorities for Pharma and healthcare industries.
2. Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module.
3. Medical Device Regulatory Affairs (International perspective, USA) Part 1.
4. Medical Device Regulatory Affairs (International perspective, USA) Part 2.
5. Medical Device Regulatory Affairs (International perspective, EU) Part 1.
6. Medical Device Regulatory Affairs (International perspective, EU) Part 2.
7. Medical Device Regulatory Affairs (Indian perspective).
8. Medical Device Registration, e-Submissions and Approvals in US, Europe and India.

Eligibility

Any Life sciences graduate/B Pharm/ M. pharm, M.Sc in science disciplines/ any diploma /degree holders. Working professionals of any of the following industry types Drugs or Food manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the certification.

Registration

The registration dates for this certification run by the institute are updated timely on the webpage. Effective E- learning tools incorporated into the design of the webpage make the certification lectures, videos and study resources easily accessible. This gives huge window of self-regulated and self-paced performance to the participants. After registration confirmation by the institute, required study resources, assessment test papers will be dispatched to the participants. This study resource is considered sufficient for the preparation of the certification exam. However, the participants should feel free to go through other study resources and resources as well. The certification examination will be notified after 2 months of the registration.

Certification and Membership Fees

Rs.20,000/- for Indian nationals and 600 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs. 4500/-(USD 125 for overseas) is optional to pay in order to avail the services of Certified Study Resources and training for the preparation of the certification exam.

Assessment & Certification

All the participants are expected to appear for online assessment. After successful completion the participants will be Certified Medical Device Regulatory Affairs Professional by IGMPI. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process

Re- Examination

In case the participant is not able to pass the certification exam in first attempt/exam notification, he/she will have to re- register for the next scheduled examination by submitting re- registration form along with the re- registration fee of Rs. 1500/-(50 USD). However, the participants will be given sufficient flexibility in scheduling their “First” certification exam.

Placement Assistance & Corporate Relations

IGMPI offers placement assistance to its students. The Institute has partnered with many organizations for providing placement assistance to its participants. Besides, it has a robust placement cell comprising senior level Human Resources professionals and Talent Acquisition experts which maintain close links with business industry. This cell is continuously engaged in promoting employability of our participants. The efforts of our placement cell also include helping with professional resume writing while also assisting them to polish their interview & soft skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare , Medical Devices and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon , Hindustan Syringes & Medical Devices, Wipro GE Healthcare, Medtronic, Bausch & Lomb, Baxter, Sushrut Surgicals, Wipro Technologies, HCL Technologies etc.


Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280

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