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China New Requirements for Local Testing of Foreign Class II and …

WEBOn October 21, 2021, the Chinese health authority (NMPA) has published a new regulation related to the requirements of Local testing as part of medical devices …

Actived: 7 days ago

URL: https://globalregulatorypartners.com/china-new-requirements-for-local-testing-of-foreign-class-ii-and-class-iii-medical-device/

An Introduction to Registration of Food Supplements in China

WEBPlease Note: The steps outlined are a simplified process flow, it excludes the preparations steps prior to registration. Step 1. Testing agency: Currently, the …

Category: Health Go Health

China Health Authority (NMPA)

WEBChina’s NMPA Regulations China’s Health Authority previously known as the China State Food and Drug Administration (CFDA) was renamed in 2018 to National Medical …

Category: Food, Medical Go Health

China (NMPA) Regulatory Intelligence

WEBIn China, the regulating Health Authority is The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The …

Category: Food, Medical Go Health

China’s National Medical Products Administration (NMPA)

WEBChina’s Health Authority: In China, Medical Devices are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical …

Category: Medical Go Health

Mexico Health Authority (COFEPRIS)

WEBMexico’s Health Authority ( COFEPRIS) COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos …

Category: Health Go Health

Japan Dietary Supplements Regulations

WEBJapan Food supplement Regulations In Japan, Nutraceuticals or food supplements, known as “health foods”, include two categories; Foods with Nutrients Function claims and …

Category: Supplements, Food Go Health

Presentation: Registration of New Drugs in Mexico

WEBReviewed Topics: Mexico’s Health Authority; Definitions; Classification of Drugs in Mexico; Steps of the Drug registration process; Content of registration dossier

Category: Health Go Health

How to Register a Hand-Sanitizer with the US FDA

WEBGlobal Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical …

Category: Medical Go Health

Mexico's COFEPRIS

WEBRegistering your medical device for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of …

Category: Medical Go Health

Mexico's Cofepris has Issued New Guidelines for Changes to …

WEBCOFEPRIS issued a revised guideline on August 9 (Gua De Criterios Para Clasificación de Modificaciones de Registros Sanitarios de Dispositivos Médicos) in …

Category: Health Go Health

Canada's Health Canada

WEBGRP Medical Device Services: Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in Canada who can develop the appropriate …

Category: Medical Go Health

Brazil's Anvisa approves Rules for travelers entering Brazil

WEB2) Traveler’s Health Declaration: Proof, printed or in electronic media, of completion of the declaration no later than 24 hours prior to departure for Brazil. 3) Proof …

Category: Health Go Health

China’s NMPA Announces Electronic versions of Drug & API Export

WEBFrom Dec 1, 2022, the electronic certificates of the Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product will be put into use. The electronic certificate …

Category: Health Go Health

Registration Process of Medical Devices and IVDs in Brazil

WEBBrazilian Registration Holder (BRH) is necessary for Registration. Manufacturers must prepare a Technical File that includes clinical data, clinical studies, …

Category: Health Go Health

United States' FDA issues guidance on Pre-IND meetings during …

WEBSubmission of Pre-IND Request: Sponsors will have three options for submitting their pre-IND meeting requests: Option 1 (preferred): Electronic Submission …

Category: Health Go Health

Drugs Registration in Mexico

WEBCOFEPRIS through the Sanitary Authorization Commission (CAS) is the one who in charge of decide the sanitary registration of drugs in Mexico. New Molecule Committee of …

Category: Health Go Health