South Korean MFDS reduces submission requirements for high-risk medical devices

South Korea – South Korean MFDS reduces submission requirements for high-risk medical devices

The South Korean Ministry of Food and Drug Safety (MFDS) has moved to reduce registration submission requirements for Class IV high-risk medical devices. According to...
Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export

Malaysia – Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export

Malaysia’s Medical Device Authority (MDA) has published draft guidance on importing products for re-export. The draft guidance follows the publication of the Medical Device...
Singapore HSA issues new guidance on special authorization routes for medical devices

USA – Singapore HSA issues new guidance on special authorization routes for medical devices

The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for medical devices not yet registered in the country. SARs...
Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export

Malaysia – Malaysian MDA medical device regulatory changes underway

Malaysia’s medical device market regulator, the Medical Device Authority (MDA), recently held a conference in Kuala Lumpur to discuss updates to the country’s device...
India Plans to Bring All Medical Devices Under CDSCO Oversight in December

India – India Plans to Bring All Medical Devices Under CDSCO Oversight in December

The Indian government is planning to give the Central Drugs Standard Control Organization (CDSCO) oversight of the import, manufacture and sale of all medical...
Medical device, IVD regulatory updates announced by Indian CDSCO

India – Medical device, IVD regulatory updates announced by Indian CDSCO

India’s Central Drugs Standard Control Organization (CDSCO) has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic products. First,...
Nouvelle définition des dispositifs médicaux pour inclure les nébuliseurs et les seringues

Inde – Nouvelle définition des dispositifs médicaux pour inclure les nébuliseurs et les seringues

Le ministère de la Santé devrait notifier une nouvelle définition des dispositifs médicaux qui étendra la portée de la réglementation à tous les produits,...
Australian regulatory action on breast implants and breast tissue expanders

Australia – Australian regulatory action on breast implants and breast tissue expanders

The Therapeutic Goods Administration (TGA) has today released the findings of its review into breast implants and breast tissue expanders following reports of around...
India Plans to Bring All Medical Devices Under CDSCO Oversight in December

India – India To Enhance Oversight Of Medical Devices

India's Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices (i.e., India's equivalent of the United States’ FDA)...
Dialogue with Chinese authorities on medicine regulation

China – China Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme

China has joined the International Medical Device Regulators Forum’s (IMDRF) national competent authority report (NCAR) exchange program. NCAR supports the global distribution of post-market...

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