Medical Device Regulations
A Complete Guide
- 1st Edition - January 20, 2022
- Latest edition
- Author: Aakash Deep
- Language: English
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers th… Read more
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety.
The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements.
- Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries
- Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan)
- Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Medical device industries, clinical research organizations (CROs), ethics committees, regulatory authorities, international regulatory agencies and organizations, notified bodies and students and graduates in healthcare, Biomedical Engineers, Clinical Engineers, Policy Makers
1. Introduction of medical devices
2. Ethics of clinical trials of medical devices
3. Regulations for medical devices in the United States
4. Regulations of medical devices in Europe
5. Regulations of medical devices in ASEAN countries
6. Regulations of medical devices in Japan and China
7. Regulations of medical devices in Canada
8. Regulations of medical devices in India
9. Regulations of medical devices in Australia
10. Regulations of medical devices in GCC countries
11. Regulations of medical devices in Sri Lanka
12. Regulations of medical devices in Russia
2. Ethics of clinical trials of medical devices
3. Regulations for medical devices in the United States
4. Regulations of medical devices in Europe
5. Regulations of medical devices in ASEAN countries
6. Regulations of medical devices in Japan and China
7. Regulations of medical devices in Canada
8. Regulations of medical devices in India
9. Regulations of medical devices in Australia
10. Regulations of medical devices in GCC countries
11. Regulations of medical devices in Sri Lanka
12. Regulations of medical devices in Russia
- Edition: 1
- Latest edition
- Published: January 20, 2022
- Language: English
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Aakash Deep
Dr. Aakash Deep is currently working as an Assistant Professor in the Department of Pharmaceutical Sciences at Chaudhary Bansi Lal University, Bhiwani. Dr. Deep was awarded B. Pharm. degree from Kurukshetra University, Kurukshetra (2006), and M. Pharm. in Pharmaceutical Chemistry from Guru Jambheshwar University of Science & Technology, Hisar (2008). He received his PhD degree in pharmaceutical sciences from Maharshi Dayanand University, Rohtak (2015). Dr. Deep was awarded Junior Research Fellowship and Senior Research Fellowship from University Grant Commission, New Delhi, and was awarded the Best Thesis Award for the good work in PhD. Dr. Deep is a recipient of the Young Pharmacy Teacher Award, 2016 by APTI, Haryana State Branch and Best Thesis Award (2015–16) by Maharshi Dayanand University, Rohtak.
Affiliations and expertise
Assistant Professor, Department of Pharmaceutical Sciences, Ch. Bansi Lal University, Bhiwani and Senior Scientist, CSIR- Central Scientific Instruments Organisation, Chandigarh, IndiaRead Medical Device Regulations on ScienceDirect