Singapore is expected to institute new requirements for medical device registration within the next few years. Currently, very few medical devices are subject to mandatory product registration in Singapore. Among those products that do require registration are radiation-emitting equipment, contact lenses and... Read More
There are several issues that foreign manufacturers will want to keep in mind in navigating the regulatory process in Thailand. First, in order to import medical devices into Thailand, an importer must first apply for and receive an import authorization and registration... Read More
While obtaining approval for pharmaceuticals is a cumbersome process in almost any country, the procedure can seem exceptionally complex and sometimes unfathomable in China. Registration of a new imported drug can take anywhere from 8 months to 2 years or more. Furthermore,... Read More
Last summer, the Korean government put into service a new law, the “National Health Insurance Act,” which, among other things, significantly changed Korean government policy regarding reimbursement of medical devices. Government approval of the listed coverage and price is required before a... Read More
The Bureau of Pharmaceutical Affairs, Under the Department of Health (DOH), regulates medical devices in Taiwan. Devices are classified into three classes. Class I consists of devices that are not life supporting or life sustaining and which do not present unreasonable risk... Read More
Medical devices were not required to be formally registered for sale in China until late 1994. Since then, however, several regulations with regard to the import and sale of medical devices have been implemented. The State Drug Administration (SDA) is the central... Read More
Despite Hong Kong’s reversion to China in 1997, under the terms of its return, Hong Kong is exempt from the rules and regulations outlined above for Chinese medical devices. Hong Kong does require general registration of imported medical devices, but there are... Read More
In India, the major sources for pharmaceutical regulation are the Drugs and Cosmetics Act of 1940 (DCA) and the Drugs and Cosmetics Rules (DCR). This legislation applies to the whole of India and all products, whether imported or made in India. The... Read More
Though the government has indicated in the past that it plans to establish a medical device certification system, at present there are no requirements for registration of medical devices in Malaysia. Malaysia does require that FDA, CE mark, or other international approval... Read More
The importation of medical devices that have not yet been approved by the Japanese government falls into two broad categories, based on the purpose of the importation. The first category is for products being imported for personal use by individuals, while the... Read More