Regulatory aspects of medical devices in India

Targhotra, Monika; Aggarwal, Geeta; Popli, Harvinder; Gupta, Madhu

doi:10.5138/09750215.2147

Cited by 6 publications

(3 citation statements)

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“…Classification and regulation of surgical devices is controlled by the Health Ministry of India (part of the Indian Government) [36] , [37] . The manufacturer’s regulatory team identified that the RAIS system is considered as a Class-A device (Low-risk surgical instrument) and worked with the Design Team to compile the requisite documentation.…”

Section: Resultsmentioning

confidence: 99%

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Webb

Bridges²,

Aruparayil

et al. 2022

IEEE J. Transl. Eng. Health Med.

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Background: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. Objective: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. Methods: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for ‘surgical device design in low resource settings’ and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. Results: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. Conclusions: Using a context-specific development approach with close engagement of stakeholders was crucial to develop the RAIS system for low-resource regions. The outcome is translation from global health need into a fully realized commercial instrument which can be used by surgeons in low-resource regions across India.

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Section: Resultsmentioning

confidence: 99%

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Webb

Bridges²,

Aruparayil

et al. 2022

IEEE J. Transl. Eng. Health Med.

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“…In India nowadays, CDSCO is the sole regulatory body governing rules and regulations for medical devices. It from time to time frames and amends the law to guarantee safety to public health [16].…”

Section: Regulatory Aspectsmentioning

confidence: 99%

Global Outlook on Medical Device Industry

Lalwani

Suvarna

2021

Int J Pharm Pharm Sci

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Medical devices assume a significant job in providing various healthcare services. The purpose of this article is tantamount to bring about the highlight key insights of the medical device industry and current innovative developments taking place, unique insights, and expectations for coming years from medical device industry professionals around the world. Global markets expect from the sturdiest growth, biggest regulatory challenges. The rising occurrence of acute diseases, regulatory requirements, and consistency in innovation is central point driving the medical device business sector development, later it is significant for the medical device industry to regularize and enhance the method to take into account the requirements of patients.

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“…We will compare the medical device rules in India, Europe (MDR), and the USA, highlighting the need for harmonization and the steps involved in obtaining licenses to manufacture medical devices. 11,12 Numerous countries encounter difficulties in obtaining appropriate high-quality medical devices and equipment tailored to their unique epidemiological needs. This challenge is particularly notable in developing nations, where health technology assessments and minimal regulatory oversight are scarce to prevent the importation or use of inferior devices.…”

mentioning

confidence: 99%

ISO 13485:2016 – The Gateway of Global or Regional Harmonization for Medical Device Regulations

Jadhav,

Shendge

2024

IJPQA

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The present review article emphasizes the pivotal role of ISO 13485:2016 in facilitating the global harmonization of medical device regulations. Compliance with this standard is crucial for manufacturers aiming to access international markets, including India, Europe, and the USA. Harmonization of regulations simplifies the process of obtaining licenses and approvals, reducing burdens on manufacturers and enhancing patient safety. By implementing effective quality management systems, manufacturers can navigate the complex regulatory landscape and contribute to the global healthcare industry. The review article also underscores the diversity of medical devices available and acknowledges the substantial expansion of the Indian market. It discusses the stringent regulations outlined in the Indian Medical Device Rules (IMDR) 2017 and the challenges faced by nations in accessing high-quality medical devices. Furthermore, it touches upon the European Medical Device Regulations and the dynamic regulatory environment in the USA. In conclusion, the paper underscores the importance of ISO 13485:2016 in achieving global and regional harmonization of medical device regulations, thereby facilitating market access for manufacturers and confirming the assurance of safe and effective medical device products to patients worldwide.

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Regulatory aspects of medical devices in India

Cited by 6 publications

References 0 publications

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Global Outlook on Medical Device Industry

ISO 13485:2016 – The Gateway of Global or Regional Harmonization for Medical Device Regulations

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