https://www.jyoungpharm.org/sites/default/files/10.5530jyp.2016.1.3.pdf

Medical Device Regulations: A Current Perspective

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

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The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

ABSTRACT Introduction Although similar in many aspects of manufacturing and regulatory provisions to medicines, medical devices have their provisions and attract considerable investments in manufacturing and innovation. While the U.S. holds the leading global position in the devices market, Asia Pacific (APAC) countries like China, Japan, Singapore, and South Korea have proved tremendous market potential holding top ten positions. Still, many APAC countries are import-reliant due to hurdles in technological innovation and regulatory provisions. Areas covered The review aimed to explore those predictors or hurdles and analyzed these to enhance the region’s export capacity gradually. Expert opinion Policymakers in APAC countries with no device manufacturing and health technology assessment capacities would be benefited from the review. The findings showed the presence of a gap in manufacturing, innovation, and marketing of devices within the APAC region and between APAC and western countries. Stringent regulatory measures and quality indicators are still lacking in many APAC nations, and there is an urgent need to harmonize regulatory standards. Being a region constituting over one-third of the global population, a considerable investment in innovation, manufacturing, and establishing quality standards is urgently needed among APAC countries to ensure an adequate supply of quality medical devices.

Gap analysis in manufacturing, innovation and marketing of medical devices in the Asia-Pacific region

Abstract Due to globalization and the quick development of technology, each government aims to ensure the safety and performance of products brought to their markets to protect its population. The peoples’ health state is of great significance and influenced easily by the quality of medical products. Therefore governments enact laws, directives and regulations to assure that quality. Nevertheless, these regulations can impede innovation and create trade barriers which result in an adverse effect on national economies. Where in some states no regulatory system is installed, others have highly sophisticated registration requirements that must be met. These diversities result in a challenge especially for small and medium sized companies, whose resources are often limited. [1] Manufacturers must control these diverse regulatory requirements by analyzing each market. Therefore an efficient procedure of registration should be defined that streamlines different registration requirements and ensures regulatory compliance. Next to regulatory authorities describing these requirements also harmonization groups play an important role in the design of the global regulatory landscape. Therefore also the most important harmonization groups and their current activities were investigated. The analysis showed that the impact of harmonization groups can be identified easily since new defined or updated regulatory requirements are oriented on their guideline. Still the harmonization of regulatory requirements in the medical device sector is not sufficiently enhanced. Thus the confrontation with each national regulatory system is inevitable.

Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products

The privatization of health services is an emerging trend in Asia. China and Vietnam are no exceptions, with their reforms to promote private hospitals gradually developed in early 1990s. As newcomers to the health-care system, private hospitals must achieve legitimacy in a state-dominated system in order to survive and develop. This paper describes the strategies of the quest to gain legitimacy from the state through “public-lization” and from the public through a campaign to associate private hospitals with professionalism, a caring environment, and customer orientation. It argues that, in a transitional economy, when the state is allocating power to other sectors but maintaining a central position, private hospitals must be careful to seek legitimacy from the state and, equally importantly, their customers. Improvements to the institutional environment to ensure better regulation are recommended, as well as professional self-scrutiny and consumer participation.

Rambabu S

Papers

Harmonized Medical Device Regulation: Need, Challenges, and Risks of not Harmonizing the Regulation in Asia