Year: 2025
Type: article
Abstract: Knee implants are essential medical devices used in orthopedic surgeries to replace or support damaged knee joints. Regulatory frameworks are crucial to ensuring that these devices meet high safety, quality, and efficacy standards before they reach the market. This article compares the regulatory affairs in India and Japan, focusing on the approval processes, classification systems, post-market surveillance, and alignment with international standards. Through a thorough review of literature, a comparative analysis, and discussion of challenges and opportunities, this article aims to shed light on the strengths and weaknesses of the regulatory frameworks in both countries.
Authors: Y. Ratna Sindhu, B. Suresh, K. Madhu Sree, G. Manikanta, A. Manikanta
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4408955978