The Malaysian government adopted two laws this year that will replace a voluntary registration scheme for medical devices with mandatory requirements once they are fully implemented. Among other matters, Act No. 737 sets forth registration requirements for manufacturers and conformity assessment bodies. Failure to register a medical device under its terms can be punished with three years of imprisonment or fines of up to 200,000 ringgit (US$66,000). Full implementation will occur by 2014. Act No. 738 establishes the Medical Device Authority, which will oversee the industry and enforce the new medical device laws, and details its powers and obligations including the development of regulations to carry out the law.