Malaysian Regulatory Requirements: Medical Devices

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 documentation accompany those products that are considered “experimental” in their country of origin when they are imported. The only other exception is for x-ray and other radiation emitting equipment. The import of such equipment requires a permit from the Ministry of Science, Technology, & Environment’s Atomic Energy Licensing Board.