China’s pharmaceutical regulatory agency has changed the way it categorizes chemical and biologic drugs, according to a series of notifications that went into effect July 1. The new drug registration categories released by the National Medical Products Administration (NMPA) better delineate the... Read More
Moving to further strengthen the safety management of medical devices that are implanted into the human body, the Ministry of Food and Drug Safety is instituting a new tracking system called – “Implanted Medical Device Safety Information Check System” – which will go into... Read More
Being a local agent for medical devices in China is going to get significantly more rigorous. Some of the new requirements now in draft form will be implemented soon. According to the new regulations, the NMPA organized the drafting of “Measures for... Read More
For this first time since 2018, holders of medical device licenses in Indonesia will be able to apply this year for inclusion in the government’s popular online catalogue, the Indonesia Ministry of Health has announced. The online purchasing system currently lists over... Read More
China is drafting plans to increase penalties on pharmaceutical companies that manipulate prices, sell counterfeit drugs or otherwise violate pharmaceutical laws. The plans include a credit rating system to incentivize drug firms to lower prices in exchange for access to China’s vast... Read More
With cyber technologies occupying growing prominence in Japan’s health marketplace, the government has released guidance on protecting medical devices from computer network threats. The guidance from the Pharmaceutical and Medical Devices Agency (PMDA) does not impose new strictures on the manufacture,... Read More
Medical device manufacturers marketing their products in Malaysia will be required to report to government authorities any events related to their use that could negatively impact patient’s health, under a Medical Device Authority regulation that went into effect on July 1. The... Read More
Moving to further streamline and modernize its process for reviewing therapeutic products, the Therapeutic Products Branch of Singapore’s Health Sciences Authority (HSA) is instituting a new online documentation process. The new form will allow applicants to file registrations for multiple products through... Read More
Facing widespread outcry from medical providers, government health authorities have scrapped a plan to limit how much hospitals and clinics could charge patients for certain medical devices. The policy set to go into effect August 1 would have capped maximum allowable consumer... Read More
New requirements issued in May mandate that pharmaceuticals produced in Indonesia contain at least 30% or more raw materials that are domestically produced. The requirements from the Indonesian Ministry of Industry have been in development for months and have yet to be... Read More