ABSTRACT
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process dem
TABLE OF CONTENTS
part |2 pages
Part 1 Introduction
part |2 pages
Part 2: Medical Device Safety and Related ISO Standars
part |2 pages
Part 3 Harmonization of Medical Devices in Asia
part |2 pages
Part 4: Medical Device Regulatory System in the United States and the European Union
part |2 pages
Part 5: Medical Device Regulatory System in Asia-Pacific Region