Earlier in March, the Chinese NMPA issued new regulations for API DMFs in China. Now, DMF manufacturers need to pay the NMPA about $50,000 to get their APIs activated in China whereas there used to be no government fee. Also, more documents are needed. The following documents and samples are required... Read More
Medical device manufacturers face new regulations on the sale and distribution of their products in Taiwan, under a law put into effect by the country’s president in January. The Medical Device Management Act is wide-ranging. It tightens the classification system of medical... Read More
Under draft classification guidance released by Malaysian health regulators, in vitro diagnostics tests on blood, tissue and other samples in Malaysia would be separated into four categories based on the risk they pose to consumers. The new draft regulations were released in... Read More
Medical institutions in Shanghai that provide online diagnosis and treatment during the COVID-19 outbreak will now be eligible for reimbursement by China’s national health insurance authority. Under a pilot program, services to be covered include online follow-up consultations for common and chronic... Read More
Pharmaceutical companies seeking to deepen penetration of Singapore’s market are coming up against barriers to ensuring their intellectual property is protected and to keeping down costs of conducting clinical trials. The pharma industry is rising in importance in the country’s manufacturing sector.... Read More
New packaging and labeling requirements on medical devices imported to South Korea that went into effect in January have been revised by the country’s Ministry of Food and Drug Safety (MFDS). The revised regulations clarify the type of medical devices subject to... Read More
With U.S. medical personnel and institutions facing key supply shortages in fighting the COVID-19 virus outbreak, trade officials in March removed tariffs on dozens of medical items imported from China. The tariff exemptions on face masks, exam gloves, surgical drapes, protective gowns,... Read More
Concerned India may lack sufficient supply of drugs to treat symptoms of the COVID-19 virus, the Indian government will restrict exports of certain pharmaceuticals produced within its borders, India’s Ministry of Commerce and Industry announced on March 3. Among the 26 active... Read More
Medical devices exported to South Korea are subject to new packaging and labeling requirements under guidance issued by the Ministry of Food and Drug Safety that went into effect in January. The new regulations, in the pipeline for a year, had been... Read More
Manufacturers of medical devices will be required to take specific actions to eliminate or mitigate potential risks associated with the use of their products already on the market in Singapore, under new regulations published by the country’s Health Sciences Authority (HSA). The... Read More