DUBLIN, April 25, 2016 /PRNewswire/ --

Research and Markets has announced the addition of the "Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies - Market Analysis & Forecast to 2020" report to their offering.

The market for sterile medical packaging is estimated to grow from USD 26.55 Billion in 2015 to reach USD 35.07 Billion by 2020, at an estimated CAGR of 5.72%.

The sterile medical packaging market has been growing in accordance with the growth in the packaging industry. Factors such as increasing aging population, growing demand from the healthcare sector, and the popularity of using reliable packaging are driving the demand for sterile medical packaging.

The growing demand in the sterile packaging market highlights the need to implement an efficient regulatory framework. The European regulatory framework is stronger, effective, and organized. Countries such as France, Germany, Italy, and the U.K. have been considered for the study. The EU has implemented standards & regulations such as Medical Device Directive, which is applicable in the European Union and eliminates the trade barrier and significantly improves the processes involved in the sterile medical packaging industry.

On the basis of key regions, the market for sterile medical packaging is segmented into North America, Europe, Asia-Pacific, and Rest of the World (RoW). The Asia-Pacific region is projected to be the fastest growing region, by 2020. This is mainly due to emerging economies in China and India, coupled with rising consumer spending power and the growing middle-class population.

The regulatory framework in the sterile packaging market is complex and varies from region to region. However, in order to avoid confusion among manufacturers and ease the trade barrier, continuous efforts are made to harmonize the multiple standards and regulations to form global standards.

The report studies and covers sterile packaging regulations and legislations in North America, Europe, Asia-Pacific, and RoW. The regions have been further studied based on laws prevalent in the top countries. The countries studied in the report include the U.S., Canada, Mexico, Germany, France, the U.K., Italy, China, Japan, India, Australia, Brazil, Argentina, and South Africa.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Market Overview of Sterile Medical Packaging

5 International Governing Bodies

6 Regulatory Framework for Sterile Medical Packaging in North America

7 Regulatory Framework for Sterile Medical Packaging in Europe

8 Regulatory Framework for Sterile Medical Packaging in Asia-Pacific

9 Regulatory Framework for Sterile Medical Packaging in RoW

10 Appendix

Governing Bodies

International Governing Bodies

American Society for Testing and Materials (ASTM) ASTM Committee F02 International Organization of Standardization (ISO) U.S. Food and Drug Administration (FDA) International Medical Device Regulatory Forum (IMDRF)

Key Governing Bodies in the U.S.

FDA

Key Governing Bodies in Canada

Health Canada (HC)

Key Governing Bodies in Mexico Federal Commission for the Protection Against Sanitary Risk (COFEPRIS)

Key Governing Bodies in Germany

Federal Ministry of Health

German Institute for Standardization (DIN)

Key Governing Bodies in the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Department of Health (DH) Association of British Healthcare Industries (ABHI) The British Standards Institution (BSI)

Key Governing Bodies in France

National Agency for the Safety of Medicine and Health Products (ANMS)

Key Governing Bodies in Italy

Ministry of Health (MOH)

Italian Medicines Agency

Key Governing Bodies in China China Food and Drug Administration (CFDA)

Key Governing Bodies in Japan

Ministry of Health, Labor and Welfare (MHLW)

Key Governing Bodies in India CENtral Drugs Standard Control Organization (CDSCO)

Key Governing Bodies in Australia

Therapeutic Goods Administration (TGA)

Key Governing Bodies in Brazil

National Health Surveillance Agency (ANVISA)

Key Governing Bodies in Argentina

National Administration of Drugs, Foodstuffs, and Medical Technology (ANMAT)

Key Governing Bodies in South Africa

Medicines Control Council (MCC)

For more information visit http://www.researchandmarkets.com/research/jgpk7c/regulatory

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