The China Food and Drug Administration (CFDA) recently adopted new regulations for medical device recall. The new rules expand the definition of defective products that require recall. Under the new regulations, devices that do not comply with compulsory standards or present an... Read More
In January, 2017 the China Food and Drug Administration (CFDA) released a new industry standards report on quality management for medical devices. The new and updated requirements are intended to emphasize the importance of adhering to CFDA regulations. The quality management system... Read More
In late January, 2017, India’s Central Drugs Standard Control Organization (CDSCO) finally released Medical Device Rules, which establish different regulatory norms for medical devices and drugs. For over 10 years, the Indian government has been trying to set up new medical device... Read More
Vietnam has new regulations that now require registration for all medical devices imported into Vietnam. Starting in 2017, all imported medical devices are required to be registered for marketing authorization licenses. Previously, only 24 items required registration, and the license was valid... Read More
This article was also published on MedTech Intelligence. Regenerative medicine focuses on harnessing the body’s ability to heal itself by restoring the functionality of damaged tissues and organs. Current medicine treats symptoms but oftentimes does not repair the underlying problems, which is... Read More
In late 2016, Korea’s Ministry of Food and Drug Safety (MFDS) announced a revision draft for medical device clinical trials. Key revisions to the regulations include: For pilot clinical trials, the MFDS has eliminated the need to calculate the number of subjects... Read More
The China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, which outlines the entire clinical trial process for drug developers. The guide provides a comprehensive overview of the drug development process, including fundamental ethical principles and more detailed... Read More
Under the Medical Device Act of 2008, companies with registered medical devices (business operators) must prepare and submit reports about malfunctions experienced by medical devices to the Thai Food and Drug Administration (FDA) concerning devices they manufacture, import, sell, or where the... Read More
In November 2016, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) reported that it has achieved the fastest median review time for new drug approvals in 2014 and 2015 among five other major regulators (US, Canada, Australia, Europe, Switzerland). In 2015, the median... Read More
The Medical Device Authority Ministry of Health in Malaysia recently released draft guidelines for “drug-medical” and “medical-drug” combination products. Previously, Malaysia lacked standards for combination product registration and regulatory requirement. Despite these draft guidelines, registering combination products in Malaysia will still take... Read More