The Singapore Health Sciences Authority (HSA) released an announcement that QMS requirements for Class A medical devices have been reduced. Essentially, all that is required now is a signed Declaration of Conformity. Foreign device companies have complained about the difficulty of fulfilling... Read More
On November 12, 2011, the United States and eight other countries jointly announced the outline for a new Trans-Pacific Partnership (TPP) on trade and investment. This landmark partnership aims to coordinate economic activity, regulatory standards, and tariffs in all trade areas. In... Read More
Singapore passed the Health Products Act in February 2007. This Act has been implemented in stages throughout the past few years. Under this Act, all Class A-D products require Singapore medical device registration with the Singapore HSA. Also, manufacturers, dealers, importers and... Read More
The Health Products Act (HPA) regulates the manufacture, import, supply, and advertisement of health products in Singapore. Originally passed in November 2007, the HPA is being implemented in phases to minimize the impact on the medical device industry in Singapore. On May... Read More
Following its recent medical device regulation overhaul, Singapore’s Health Sciences Authority (HSA) is planning to carry out further adjustments to the nation’s medical regulations. At present, there are a number of different notifications that collectively operate to control the importation, sales and... Read More
Before Singapore's Health Products Act 2007, most medical devices did not fall under governmental regulations. From August 1, 2010 onwards, all of these medical devices need to be re-registered under the Health Products Act 2007 guidelines using the online Medical Device Information... Read More
Singapore’s Health Sciences Authority (HSA) included secondary assembly activity guidelines in its medical device Technical Specification 01 (TS-01) in early July 2010. Manufacturers that make use of secondary assembly must meet new regulations by August 2011. HSA defines secondary assembly activity as... Read More
Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
During a bilateral India-Singapore Comprehensive Economic Cooperation Agreement (CECA) review meeting on May 11, 2010, representatives of both parties signed an agreement to allow easier access for Indian generic (off-patent) drugs in Singapore. The Indian commerce and industry minister Anand Sharma and... Read More
The Health Sciences Authority (HSA) of Singapore and the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labor and Welfare (MHLW) together with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan met in Singapore to sign an agreement that... Read More