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Registration Process
The Thailand Cosmetic Regulation or Cosmetic Act B.E. was officially finalized in the year 1992. Thailand’s Ministry of Public Health has updated its lists of prohibited and restricted substances for use in cosmetic products.
Many of the chan
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The Philippines’ Food and Drug Administration (FDA) recently had a consultation to examine the draft of Circular to prohibit the use, manufacture, importation/exportation, distribution, sale, and storage of medical products that contain mercury
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On the 17th of September 2021, India overturned its ban of recycled plastic in 2018, now allowing the use of recycled plastic in Food Contact Materials (FCMs). The exception to the new rule is that it doesn’t include chemical migration limits, that
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Health Canada has released a proposal for public comment to create a unified regulatory framework for disinfectants and sanitizers. In Canada, biocidal products are currently governed by distinct regulatory systems. Surface sanitizers are governed
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Thailand Existing Chemicals Inventory (TECI) is the national inventory that contains chemical substances imported and produced in Thailand. The development of TECI is part of a project listed under the 4th National Strategic Plan on Chemical Manageme
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It is The part of the States Department of Health and Human Services and is one of the United States federal execuve departments. New drugs, including biologics, Food addives for people and animals, Color addives in food, drugs, and cosmecs for peopl
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The FDA exercises authority for inspecons of facilies in foreign countries which supply pharma and food products to the US. So, pharma and food plants in countries that export to the USA must adhere to the CGMP (current good manufacturing pracces) as
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The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or pharmaceuticals, medical devices, food and dietary supplements, in United States.
U.S. agent and roles and responsibilities of the U
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Section415(a)(3) of the FD & C Act requires facilities that are required to register with FDA to renew their registrations every other year, during the period beginning on October 1 and ending Contains
(Nonbinding Recommendations 37) on
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Medical Devices Regulation in the United States
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this prog
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Legal Basis and the Authority
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this prog
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Overview
FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic Act (FD&C Act). The FD&C Act contains provisions, that is, regulatory requirements, that define FDA's leve
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Objectives of FDA
The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA.
FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices. Medi
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Device Registration
The FDA does not “certify" devices, and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue registration certificates to medical device facilities nor does the FDA certify info
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Labelling
Before a pesticide can be sold or disseminated in the United States, the FDA must approve all label text as part of the licensing/registration procedure. The label's overarching goal is to provide clear instructions for efficient product performa
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China- Medical devices regulation
The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in e
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Legal Basis and Authorities
The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in e
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New Regulations
In June 2021, the NMPA issued a new set of regulations that will make it easier for innovative medical devices for the treatment of urgent public health emergencies and rare diseases to obtain approval in China.
Certain products will be
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Registration Process
The chemical substances that are sold in the market must be registered in the Russian Federation. The requirement of the registration is mandatory for the main legal act in the field of environmental protection that is “On Protection of the E
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Legal Authorities
The cosmetic control in Thailand has been implemented by the Cosmetic Act B.E. 2558 (2015) which is under the regulation of Thailand FDA. The ASEAN Cosmetic Directive originated under the agreement of the ASEAN Harmonized Regulatory Scheme and the re
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Import & Manufacture of Cosmetic Product
Any company or a single individual who wants to import or manufacture cosmetics product for sale in the kingdom, must inform about the complete details of cosmetic product to be imported or manufactured to the authority of concern.
The s
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Registration of Specially controlled cosmetics
Permission for manufacturing or importing samples of products for registration is required before the registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review. The Requirements for Regi
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Regulatory Authorities
National Level
The Ministry of Health (MOH); is responsible for food hygiene, chemical contamination, food borne disease control, permission and inspection for new food, new food contact articles and food contacts additives notification approva
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Food Contact Materials Regulation
Mercosur i.e. the common market of the south, is the largest trading blocking South America.
It comprises Argentina, Brazil, Paraguay, Uruguay and Venezuela. Its associate countries include Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Surin
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Regulation Framework
The basic Framework in the Mercosur countries closely resembles the Food Contact Material and Articles regulations to that of the European Union and to some measures of the US-FDA. MERCOSUR's executive body is the Common Market Group. It is comp
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Authorties
In the USA, Food Contact Materials (FCM) is regulated under the Federal Food, Drug and Cosmetic Act (FFDCA), Title 21 of the Code of Federal Regulations (CFR), where a revised Title 21 is issued on approximately April 1st of each year and is usually
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Legal Bodies
NEPA:FDA urges the federal agencies to take the environmental considerations into account in the planning and making their decisions. NEPA is basically a declaration of the nation’s environmental policy and goals. It intensifies the FDA’s command
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Requirements of Food Contact Notification
Comprehensive Summary: The rationale for the notifier's conclusion that the usage of the FCS is safe should be summarised and discussed in detail in an FCN. While addressing all safety data given in the warning, the summary should describe cumul
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Food Additive Petition Process
Due to the introduction of the Food Contact Notification the number of Food Additive Petitions has reduced substantially. Nevertheless, the FDCA states that the FCN process will be used for food contact substances authorizations except where FDA decl
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Toxicological Information
The FDA's toxicological evaluation is based on a tiered approach and is consistent with the general principle that increased exposure results in increased potential health risks; however, the inherent toxicity of a structural/functional class of
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Nano Regulation in Food
The Food and Drug Administration (FDA) in the United States is in charge of ensuring the safety of food additives, food contact materials, and feed additives that are put on the market under the Federal Food, Drug, and Cosmetic Act (FFDCA) (US-FDA).
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Nanomaterial regulation in Cosmetics
The FDA's existing regulatory framework for nanotechnology-enabled cosmetics is in flux. In 2007, the FDA established a task force to explore the future of nanotechnology goods. The FDA has now issued advice on nano-enabled cosmetics safety (FDA,
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Nano Regulation in Device
For both the medical device sector and the regulatory agency, nanotechnology may be a new and growing subject (Such as the US FDA). Currently, the FDA has not defined nanotechnology-specific criteria to help manufacturers in deciding when a modificat
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International Conventions
International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parti
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International Regulation
International effort in addressing POPs starts in late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties t
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International Regulations
International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parti
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China Regulation
China signed the Stockholm Convention on its launch in 2001 and ratified the Convention in 2004. Since then, the initial list of 12 POPs listed in the Stockholm Convention entered the government agenda. For example, the Regulation for Pesticide Manag
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