A Malaysian law requiring companies that manufacture or market medical devices in the country to register with the government goes into full effect this month, six years after it was first passed. The 2012 law was designed to bring Malaysia, which imports... Read More
Beginning November 1, 2018, high-risk medicines sold in India will be required to carry warnings on the packaging, part of a series of moves by the country’s Ministry of Health and Family Welfare to toughen labelling norms on pharmaceuticals. Under the new... Read More
Starting June 1, Singapore no longer requires certain low risk medical devices, such as sterile medical examination gloves and intravenous sets, to be registered with the government before they are offered for sale. The change announced by Singapore’s Health Sciences Authority, the... Read More
China’s Center for Medical Device Evaluation (CMDE) has issued a new draft guidance for obtaining approval of 3D-printed medical devices, as the nation’s regulatory authorities focus new attention on the fast-developing field of 3D printing technology. The guidance, proposed by the agency... Read More
A new law implemented by Korea in January requires pharmaceutical and medical device companies to track in minute detail money spent and benefits provided to a broad spectrum of medical professionals. Called the Sunshine Act, the law is part of an aggressive... Read More
New bills aimed at promoting the use of medical devices have been introduced in Korea’s National Assembly. The government is aiming to boost the devices industry as it pursues broader reforms to expand national healthcare coverage to include all previously non-reimbursed services... Read More
The China Food and Drug Administration (CFDA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. The CFDA is separated into various departments that are individually responsible for the registration, tracking, and monitoring of medical... Read More
Japan’s Ministry of Health, Labor and Welfare (MHLW) is the regulatory body that oversees food and drugs in Japan, which includes creating and implementing safety standards for medical devices and drugs. In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA)... Read More
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the chief governmental body responsible for overseeing medical device registration, manufacturing, and distribution in South Korea. The MFDS is tasked with establishing standards... Read More
India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India. The CDSCO exercises regulatory control over the import of drugs and... Read More