Medical Device Rules - 2017, India: An Insight

Sharma, Damini; Chandra, Amrish

doi:10.2174/2666255813666190912114043

Cited by 2 publications

(2 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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“…Class II & III devices, as well as Class I devices having a measuring or sterility function, that must provide evidence of compliance with the relevant EU Directives & the particular mentioned throughout the conformity review process. Other Class I medical devices are not subject to pre-market compliances, but must adhere to mandatory safety & effectiveness principles in their design, manufacture, & labeling requirements [16].…”

Section: Overview Of European Medicines Agency (Ema)mentioning

confidence: 99%

global prospective of medical devices and their regulations

Tevetia¹,

Bhatt²,

Pathak³

et al. 2022

ijhs

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Health of the public is one of the important factors which influence the wellbeing state of a human being. The diagnosis of any chronic disease or disorder & to develop treatment for that particular diseased condition is only possible after the involvement of medical devices & combination products which wasn’t possible in previous years. The detailed differentiation of medical devices is based majorly on the risk factor involved from low risk to that of high one. To get the better understanding regarding all the medical devices the regulations prevailing to particular device can be studied. The goal of developing medical device regulation systems is to protect public’s health while also ensuring their safety & performance. These regulations of medical devices products are governed by FDA which also monitors the safety & efficacy of all medical products. Innovation further leads to manufacture of new medical device. As the pharmaceutical sector & engineering department work hand in hand which has played a vital role in the physiology of organs, better performance, & better life span & in complete replacement of that particular organ system.

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Medical Device Rules - 2017, India: An Insight

Cited by 2 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 prospective of medical devices and their regulations

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