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

On 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 registration in China: “Regulations on the Administration of Medical Device Registration and Self-inspection” To encourage the development and speed up the registration process of innovative medical devices in China, the China’s

Actived: 7 days ago

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

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

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’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

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

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

Brazil's ANVISA Approves new Normative for the Registration of …

WEBBrazil’s Anvisa published in October 2022 a new regulatory framework for new and innovative medicines that will simplify and relax the information to be submitted …

Category: Medicine 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 CDE releases Guidelines for Acceptance and Review of …

WEBChina's NMPA. China's NMPA regulates the registration of drugs, medical devices and cosmetics; as well as conduct strict review and approval for marketing of …

Category: Medical Go Health

Japan's Health Authority (PMDA)

WEBJapan’s Health Authority (PMDA) About Japan’s PMDA In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing …

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

Taiwan's Food and Drug Administration (TFDA)

WEBIn Taiwan Medical Devices are regulated by the Taiwan Food and Drug Administration (TFDA), Taiwan’s equivalent of the United States FDA. The TFDA rests under the …

Category: Food, Medical 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

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 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

Korea’s Ministry of Food and Drug Safety (MFDS)

WEBRegistering medical devices and IVD in South Korea is a complex and challenging process. Most of MFDS regulations are not that clear, are in Korean language and are changing …

Category: Medical Go Health