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
Singapore’s Health Sciences Authority (HSA) is tasked with regulating drugs, innovative therapeutics, medical devices, and other health products to meet appropriate safety, quality, and efficacy standards, as well as contributing to the development of national drug policies. The HSA evaluates product registration... Read More
Taiwan’s Ministry of Health and Welfare (MOHW) is the government ministry responsible for the country’s healthcare regulations. The MOHW has a broad mandate to improve the quality of healthcare, prevent and control infectious diseases, ensure food and drug safety, and facilitate technological... Read More
Although Hong Kong is a Special Administrative Region of China, it does not follow the same medical device or pharmaceutical regulations as the mainland. The Medical Device Control Office (MDCO) and the Drug Office under Hong Kong’s Department of Health (DH) are responsible... Read More
The Association of Southeast Asian Nations (ASEAN), which is comprised of the countries Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar, and Cambodia, was established in 1967 to promote peace and stability in the region, facilitate collaboration and mutual assistance among the... Read More
Earlier this year, India’s in vitro diagnostics (IVDs) rules of 2017 went into effect. IVDs are now classified in four classes: A, B, C, and D. The 2017 rules have a list of IVDs with their risk classification. More IVDs now require... Read More
In early September 2017, the China Food and Drug Administration (CFDA) released plans to implement a new Catalog of Medical Devices starting on August 1, 2018. The current classification directory was established in 2002 but has been under revision since July 2015... Read More
The Taiwan Food and Drug Administration (TFDA) has completed a draft of the new Medical Devices Act. The new act will effectively separate the management of medical devices from the existing Pharmaceutical Affairs Act. The draft proposal of the Medical Devices Act... Read More
Singapore’s Health Sciences Authority (HSA), which is administered by the Ministry of Health, plans to establish guidelines for telehealth devices. A telehealth device is any instrument, machine, or software that helps provide healthcare services through telecommunications. Under the proposed regulations, telehealth devices... Read More
Malaysia Medical Device Authority product classification steps (click to download full size image). Read more about why it is important to classify your product before registering your product as a device in Malaysia. For more information about our medical device or pharmaceutical registration... Read More