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
On February 6, 2018, China’s Food and Drug Administration (CFDA) and the Center for Medical Device Evaluation (CMDE) issued a new draft guidance for the approval of medical devices intended to treat rare diseases. The guidelines set out requirements for applicants to... Read More
Over the last few years, the number of clinical trials in India has dropped by 90%. In March 2018, India’s Health Ministry released a comprehensive set of rules for clinical trials that will apply to all new drugs. The rules, covering everything... Read More
In February 2018, Malaysia’s Medical Device Authority released the Second Edition of the Guidance Documents on Requirements for Medical Device Labeling. Major changes include: The labels must include the contact details of the manufacturer and authorized representative; The labels must indicate the... Read More
Taiwan’s parliament has passed a bill that establishes new protections for the intellectual property of pharmaceutical companies. The new “patent linkage” system, modeled on the U.S. “Orange Book” approach, is aimed at preventing licenses from being issued for drugs that infringe on... Read More
In April, Japan will adjust its prices for medical devices and drugs. The device price changes this year will be minor, as there will be no change to the Foreign Average Price (FAP) multiplier. The FAP multiplier is determined by the average... Read More