Registrations

FSC

The Forest Stewardship Council (FSC) is an international non-profit, multistakeholder organization established in 1993 that promotes responsible management of the world's forests. It is an example of a market-based certification program used as a transnational environmental policy.

CFDA

The China Food and Drug Administration (CFDA) (Chinese: 国家食品药品监督管理总局) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency. The CFDA replaced a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States, streamlining regulation processes for food and drug safety. The China Food and Drug Administration is directly under the State Council of the People’s Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

GMP

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

MSDS

A material safety data sheet is a technical document which provides detailed and comprehensive information on a controlled product related to:  health effects of exposure to the product  hazard evaluation related to the product’s handling, storage or use  measure to protect workers at risk of exposure  emergency procedures.

amfori BSCI

BSCI is an initiative of the Foreign Trade Association (FTA), the leading business association of European and international commerce that brings together over 1,500 retailers, importers, brands and national associations to improve the political and legal framework for trade in a sustainable way. BSCI support more than 1,500 FTA member companies to integrate social compliance at the heart of their global supply chains.

EPA

The Environmental Protection Agency (EPA) was established in December 1970 by the executive order of President Richard Nixon. It is an agency of the United States federal government whose mission is to protect human and environmental health. Headquartered in Washington, D.C., the EPA is responsible for creating standards and laws promoting the health of individuals and the environment.

China GMP

The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.

FDA Registered

All medical devices must be registered with the FDA. Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared” or “Approved,” and they cannot use the FDA logo in marketing or labeling the device.

TGA

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health(link is external), and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

Japan PMDA

The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.

U.S FDA 510(k) Cleared

The US Food and Drug Administration (FDA) requires manufacturers of certain classes of products to submit a technical dossier to demonstrate that the device is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA reviews the 510(k) submission and "clears" the specific device. Certain classes of medical devices require such clearance before they can be legally distributed in the United States.

China Whitelist

GACC will inspect and release the exports according to the list of manufacturers with foreign standard certification or registration provided by MOFCOM, which is known as the “China Medical Device Exportation Whitelist”.

ANVISA GMP

The GMP Certificate is a document issued by Anvisa attesting that a particular establishment complies with Good Manufacturing Practices.

KFDA

KFDA means Korean Food and Drug Administration. The competent regulatory authority in Korea that is responsible for granting Marketing Authorization for a regulated pharmaceutical in Korea.

NIOSH

The US Center for Disease Control (CDC) National Institute for Occupational Safety and Health (NIOSH) regulates respirators (N95 masks) for occupational health. NIOSH maintains an extensive list of approved N95 respirators. These NIOSH rated respirators are intended for industrial use, but are appropriate for healthcare use under the emergency circumstances brought on by the COVID-19 pandemic, hence these respirators will not be found on the FDA Establishment Registration & Device Listing database.

U.S FDA EUA

During the COVID-19 crisis, the FDA issued Emergency Use Authorizations (EUAs) that waived certain regulatory requirements and specifically authorized the importation and distribution of specific items listed in the EUA for the uses described in the EUA, so long as the importation, distribution or use of such items fell within the scope of authorization in the EUA. On June 30, 2021 the FDA removed a number of products from the EUA list, including KN95 masks as well as decontamination and bioburden reduction systems to disinfect disposable respirators. This action was taken in response to an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. While the FDA has revoked its EUA for KN95 masks, it does not mean that these respirators are not adequate for consumer use, only that they are no longer appropriate for healthcare workers given the abundant supply of N95 respirators.

CE

The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.