Industry Links
Looking for regulatory US requirements for medical gloves? Or how about the testing requirements within the EU? Find these answers and more in Industry Links – your go-to-resource for the most popular regulatory, government, industry, testing and health and safety websites.
REGULATORY
US Food and Drug Administration (FDA)
Regulates the sale and marketing of medical devices in the US.
REGULATORY
European Commission
Regulates the sale and marketing of medical devices within the European Union.
REGULATORY
Ministry of Health, Labour and Welfare (厚生労働省) - Japan
Provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.
REGULATORY
Agência Nacional de Vigilância Sanitária (ANVISA) - Brazil
ANVISA is a regulatory body of the Brazilian government responsible for the regulation and approval of pharmaceutical drugs, sanitary standards and regulation of the food industry.
REGULATORY
National Medical Products Administration (国家药品监督管理局) - China
The NMPA is responsible for registration of medical devices for the Chinese market. All medical devices have to be classified by the CFDA according to its risks.
REGULATORY
Ministry of Food and Drug Safety (MFDS) - Republic of Korea
Ensures the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics.
REGULATORY
Medical Device Authority (MDA) - Malaysia
The government agency entrusted to serve the Malaysia medical device’s industry.
STANDARDS
ASTM International
Establishes internationally recognized testing method standards and specifications for medical gloves.
STANDARDS
International Organization for Standardization (ISO)
ISO is a network of the national standards institutes of 163 countries coordinated by a Central Secretariat in Geneva, Switzerland.
STANDARDS
European Standards (EN)
The European Committee for Standardization or Comité Européen de Normalisation (CEN) provides an efficient infrastructure for the development of coherent sets of standards and specifications.
STANDARDS
Establishes standards for medical gloves used by emergency medical personnel under NFP 1999: Standard on Protective Clothing for Emergency Medical Operations (US).
HEALTH & SAFETY
US Centers for Disease Control and Prevention (CDC)
Establishes global infection control and prevention guidelines for hospitals, physicians, dentists and other healthcare organizations.
HEALTH & SAFETY
US Occupational Safety and Health Administration (OSHA)
Regulates US worker and workplace safety by setting and enforcing standards and by providing training, outreach, education and assistance.
HEALTH & SAFETY
World Health Organization (WHO)
Sets global health benchmarks and standards as the coordinating authority within the United Nations system.
INDUSTRY LINK
Malaysian Rubber Export Promotion Council
Tasked with undertaking market promotion of quality Malaysian rubber products in world markets.
INDUSTRY LINK
Malaysian Rubber Board (Lembaga Getah Malaysia)
Track industry news and rubber prices.