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
Tightening government control over the sale of medical devices, Korea is now setting up an authorized period of time that devices can be offered for sale before their registration needs to be renewed. Under the new rule published by Korea’s Ministry of... Read More
Changes to pharmaceutical registration regulations in China that go into effect on July 1 are designed to bolster safety requirements for clinical trials, encourage the development of generic drugs, limit fraud in clinical data and expedite the pharmaceutical approval process. For example,... Read More
If a foreign medical device company does not have its own office in China and does not want to let their distributor register their product there, registration can be done by an independent third-party company (agent) located in China. In all three cases,... Read More
Driven by the urgent need to develop more and better ventilators and other devices to treat Covid-19 patients, South Korea plans to bolster private-sector medical device research in the country with an infusion of government cash and expertise. The research and development... Read More
As part of its continuing effort to align its regulatory approach to drug registration and regulation with international practices, China is proposing modifications to the way it categorizes pharmaceuticals. The draft plans would be the first restructuring of registration classifications of chemical... Read More
Medical devices marketed and distributed in Singapore have long been subject to strict requirements that mandate any safety hazards associated with their use be reported to government authorities. Now a new online system makes reporting of what is known in Singapore as... Read More