A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

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To Recognize the Use of International Standards for Making Harmonized Regulation of Medical Devices in Asia-Pacific

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Purpose: Health care equipment international trade could serve a new strategic revenue for Indonesia. Since its implementation in 2015, AFTA has been a very strategic issue in creating export opportunities for its member countries. One of the sectors that becomes a priority for ASEAN integration is in the field of medical devices which is regulated in the ASEAN Medical Device Directive (AMDD) policy. Indonesia itself has officially ratified AMDD policy since 2018, but Indonesia will have been facing the problem of quality, innovation and diversification of medical devices. This study examines the competitiveness opportunities for domestic medical devices in ASEAN Free Trade Area. Method: This study used a qualitative method where information was obtained from in-depth interviews and document review. The informants came from policy makers, implementing officers, and stakeholders. Results: Indonesia has harmonized 26 out of 31 standards mandated by AMDD. Conformity assessment bodies in Indonesia that have been certified by the National Accreditation Committee have received international recognition. Indonesia has many potential exporting innovative medical devices to ASEAN countries. Fulfillment of medical devices is carried out through compulsory licensing and parallel import mechanism.

background

https://www.jurnal.ugm.ac.id/bkm/article/download/60819/30569

To Recognize the Use of International Standards for Making Harmonized Regulation of Medical Devices in Asia-Pacific

Citations

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Global trade and health: an Indonesian perspective on the asean medical device directive policy

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