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

WebIntroduction. COFEPRIS, Mexico’s medical device market regulator, has issued updated instructions on changes to device registrations to improve review …

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URL: https://globalregulatorypartners.com/mexicos-cofepris-has-issued-new-guidelines-for-changes-to-medical-device-registrations/

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

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

WebOverview: Brazil’s Anvisa published in October 2022 a new regulatory framework for new and innovative medicines that will simplify and relax the information to …

Category: Medicine 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 Modifies Pharmacovigilance Regulation: NOM …

WebOn October 30 2020, Mexico’s Health Authority, COFEPRIS, modifies the pharmacovigilance regulation, NOM-220-SSA1-2016, Installation and operation of the …

Category: Health Go Health

Canada's Health Canada

Web‘Natural Health Product’ Regulations of Canada: In Canada, nutraceuticals are known as Natural health products and are regulated under the Natural Health Products …

Category: Health Go Health

Mexico's Cofepris medical Device and IVD Registration and …

WebCOFEPRIS, Mexico’s the second largest medical device market in Latin America after Brazil and can be a lucrative target for medical device and IVD …

Category: Medical Go Health

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 …

Category: Medical Go Health

Brazil Health Authority (Anvisa)

WebBrazil’s Anvisa Regulations Brazil’s Health Authority known as, Agência Nacional de Vigilância Sanitária, or Anvisa, is the regulatory agency that is responsible for 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

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

WebIn South Korea, Nutraceuticals are known as “ Health Functional Food ”. They are regulated by the Minister of Food and Drug Safety (MFDS). Health functional foods are products …

Category: Food Go Health

Brazil's ANVISA Introduces New Rules on Drug labeling with RDC …

WebAs of July, the new regulatory framework for drug labeling, the RDC 768/22, from the National Health Surveillance Agency (Anvisa), comes into effect. The new …

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

Medical Device Registration in Brazil

Webfor health surveillance Decree 8077/2013, which regulates the registration, control, and monitoring of the products addressed by Law 6360/1976. Decree 8077/20136 outlines …

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

Anvisa publishes new Technovigilance Manual 2021

WebTechnovigilance is the system for surveillance of adverse events and technical complaints of health products in the post-marketing stage, in order to …

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

South korea's MFDS announces revision of Standards and …

WebThe expression “Consult a health care practitioner and stop intake if you are having adverse event” was added to warning notice;; For people with sensitive condition, …

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

Mexico Cosmetics

WebMExico's Cosmetic Regulations. Cosmetics are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). In Mexico, cosmetics are defined as …

Category: Health Go Health