The medical device market in Singapore reached $535 million last year, despite its small land area and a population of only 4.7 million. Singaporeans' strong demand for better healthcare creates an excellent market for foreign medical device companies, who supply more than... Read More
Beginning January of 2013, the Taiwanese Food and Drug Administration (TFDA) will begin trial of the Essential Principles (EP) and Summary of Technical Documentation (STED) format for class III devices, with mandatory EP/STED required for all 2014 submissions. The move is part... Read More
In line with recommendations from the Global Harmonization Task Force, the Singapore Health Sciences Authority (HSA) has implemented two new evaluation routes for Class C and Class D medical devices in Singapore as of January 1, 2013. Previous Routes: Full Evaluation Route:... Read More
The India Pharmaceutical Regulatory Report comprehensively covers all aspects of India pharmaceutical regulations. It includes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. It also includes an overview of the... Read More
The Taiwanese Food and Drug Administration (TFDA) announced that its registration and market approval documentation requirements will align with the Common Technical Document (CTD) format for e-submission. Use of the CTD format should reduce costs, labor, and time required for new drug... Read More
Japan’s Ministry of Health, Labor and Welfare (MHLW) is aiming to revise the Pharmaceutical Affairs Act (PAA) to expedite approval of for tissue-engineered medical products (TEPs). The MHLW is considering a new system that would create an exception for TEPs in terms... Read More
Beginning August 31, 2012, the Korean Food and Drug Administration (KFDA) will require medical device manufacturers in Korea to disclose more product information to the public. The KFDA has prepared a guideline on information that needs to be disclosed for medical devices.... Read More
Foreign medical companies must assign a Market Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) in Japan in order to sell their products. A DMAH is a company registered by the MHLW that performs market authorization holder services. A DMAH... Read More
In April 2012, the Korean FDA (KFDA) made significant changes in its Medical Device Act, which stipulates regulations for medical devices. The revised Medical Device Act improves transparency and predictability for medical device approval. Within the Medical Device Act, the KFDA released... Read More
Like many other Asian countries, Hong Kong is developing a more regulated, harmonized system for medical device manufacturers and importers. Though registration is currently voluntary, manufacturers will soon be required to register their products. Get a head start by viewing our webcast... Read More