Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country’s health regulatory authority has released draft guidance on how the system will work. According to the guidance, when the system is... Read More
In the latest move by India to ensure the quality and safety of medical devices produced in the country, government regulators are joining forces with leading medical device manufacturers associations to integrate industry quality management systems with regulatory requirements. The new framework... Read More
Seeking to bolster the safety of pharmaceuticals sold in Thailand, the country’s Food and Drug Administration (FDA) is imposing minimum standards established by the World Health Organization to ensure the quality and integrity of medicines throughout the supply chain. Under the Good... Read More
In a further tightening of its regulations on the sale of medical devices, India’s regulatory authority has announced a new list of devices that must obtain import and manufacturing licenses in order to be sold in the country. In accordance with the... Read More
Addressing the rising concern that some medical devices designed for use by medical professionals are being advertised and distributed on the open market, Malaysian health authorities are tightening regulations on the unauthorized sale of such devices. In a public notice published in... Read More
The majority of medical and in-vitro devices sold in Japan will be required to post package insert information to a website maintained by the country’s Pharmaceuticals and Medical Devices Agency, in accordance with a new regulation going into effect on August 1.... Read More
In an across-the-board effort announced by the Chinese government in May, the country’s health regulators are making plans to strengthen oversight of the manufacture, import and distribution of pharmaceuticals. The announcement from the General Office of the State Council outlined a range... Read More
Continuing to refine its nascent laws regulating the sale of medical devices and IVDs, Vietnam’s Ministry of Health in March drafted new legal parameters that tighten controls on classifying, testing, and conducting clinical trials of medical devices. As drafted, the new regulations... Read More
By December 1, 2021, according to the NMPA’s recent release on new Pharmacological Vigilance Quality Management Standards, Marketing Authorization Holders (MAHs) in China will have new pharmacological vigilance responsibilities. MAHs will need to have a dedicated pharmacovigilance team to deal with risk... Read More
Pushing to bolster the safety and efficacy of medical devices sold in Thailand, the country’s regulatory authority has set out new guidelines on when and under what circumstances a recall is appropriate for devices whose continued presence in the market could affect... Read More