32.Issue 07 july 26 - INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

Volume : 13, Issue : 07, July – 2026

Title:

MEDICAL DEVICE APPROVAL ISSUES IN ICH AND A FEW OTHER COUNTRIES FOR IMPROVED REGULATORY DELIVERY

Authors :

Dr. D Varun*, Gandhe Saicharan, Amarapalli Divya

Abstract :

To ensure the safety, effectiveness, and high quality of the goods, there are global monitoring systems that cover the medical device sector comprehensively. Gaining entry to every market is difficult due to the vast disparities in how regulatory systems in different countries work. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) processes, additional US, EU, Japanese, and Indian regulatory frameworks, and medical device approval procedures are all part of this study. The absence of post-market surveillance, criteria for clinical reviews, approval procedures, and various pharmaceutical classification systems are only a few of the important subjects covered in this article. Researchers have shown that manufacturers’ uneven policies are to blame for the longer wait periods for new technology. The International Conference on Harmonisation (ICH) is one of the organisations that has been trying to speed up the rule-making process by standardising technical documentation, implementing risk-based approaches, and establishing mutual recognition agreements. They are also a participant in the study. Access to medical devices may be enhanced and harmonised across all worldwide markets with a unified regulatory framework that prioritises innovation and safety.
Keywords: Harmonisation of Regulations, Medical Device Approval, International Conference on Harmonisation of Standards, and worldwide Regulatory Frameworks.

Cite This Article:

Please cite this article in press D Varun et al., Medical Device Approval Issues In ICH And A Few Other Countries For Improved Regulatory Delivery, Indo Am. J. P. Sci, 2026; 13(07).

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