MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Pacific Bridge Medical

Asian regulatory update: Asia-Pacific medical device market gets healthier

By Leave a Comment

Asia-Pacific medical device market gets healthier

The Asia Pacific (APAC) medical devices market will grow more than 10 percent over the next three years. This is higher than the projected global sector growth of 6 percent. APAC’s growth in medical devices will be driven by healthcare service providers’ demand for safe, reliable and cost-effective medical treatments, as well as consumers demanding better medical products.

The APAC medical devices market is estimated at $55 billion. This is about a quarter of the global medical devices market, valued at more than $230 billion. Medical devices manufacturers are expected to increase revenues in APAC from diseases related to diabetes, cardiovascular, orthopedic and infectious diseases.

Asian regulatory update: India’s regulated medical devices to further face price regulation

By Leave a Comment

India’s regulated medical devices to further face price regulation

The Indian government collaborated with the National Pharmaceutical Pricing Authority (NPPA) to evaluate the pricing of medical devices that are regulated under the Drugs and Cosmetics Act. The most noticeable finding was that these regulated medical devices can vary drastically in terms of selling price.

Asian regulatory update: New industry standards for medical devices in China

By Leave a Comment

New industry standards for medical devices in China

On Dec. 27, 2010, China’s State Food & Drug Administration (SFDA) website was updated with an announcement on 96 new industry standards that will affect medical devices in China. 34 of these new industry standards are mandatory (labeled YY) while the remaining 62 are recommended (labeled YY/T). The mandatory standards will be regulated beginning June 1, 2012.

Several of the mandatory industry standards are replacing other standards. For example, YY 0054-2010 for hemodialysis equipment will be replacing YY 0054-2003, and YY 0333-2010covering soft tissue dilation devices will replace YY 0333-2002. However, many others are new, such as YY 0804-2010 for medical fluid metastatis.

Asian regulatory update: India’s medical device market to grow 17% by 2015

By Leave a Comment

India’s medical device market will experience a compound annual growth rate of 17 percent over the next five years. The market will expand by 150 percent in 2015, reaching a value of $2 billion.

The homecare and handheld devices sector will more than triple. Meanwhile, therapeutics, imaging devices and patient monitoring will account for the remainder of the estimated growth.

Currently, imaging is the largest sector followed by therapeutics, patient monitoring, and then homecare and handheld products. By 2015, homecare and handheld products will likely outstrip the patient monitoring sector.

Asian regulatory update

By Leave a Comment

Hong Kong’s government currently does not strictly regulate most medical devices. However, in late August 2010, Hong Kong’s Medical Device Control Office proposed a framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. The new framework draws significantly from the Global Harmonization Task Force (GHTF) and the World Health Organization (WHO). Companies dealing with medical devices in Hong Kong should begin preparations for these upcoming regulations.

Asian regulatory update: Singapore’s HSA updates medical device Technical Specification

By Leave a Comment

Singapore’s HSA updates medical device Technical Specification

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 "the process of repackaging a medical device from its original packaging into another packaging, without breach of the primary package, before the medical device is supplied." The guidelines are to maintain the quality, safety and integrity of medical devices.

Asian regulatory update: China’s SFDA chief dismissed

By Leave a Comment

China’s SFDA chief dismissed

The deputy chief of China’s State Food and Drug Administration (SFDA), Zhang Jingli, has been removed from his post and is being investigated by an anti-corruption body, the Party of China Central Commission for Discipline Inspection. Zhang, who had held the position since 2003, is under suspicion of “serious disciplinary violations” — a standard allusion by the Party Commission to bribery and corruption. There are no further details on the nature of Zhang’s offense.

Asian regulatory update: Japan, Singapore to exchange regulatory information

By Leave a Comment

Medical regulatory information to be exchanged between Japan and Singapore

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 states that parties involved will exchange information on regulations with regards to drugs, medical devices, and cosmetics (quasi-drug included).

Asian regulatory update

By Leave a Comment

New Medical Device Management Center in China

China’s State Food & Drug Administration (SFDA) officially inaugurated its Management Center for Medical Device Standards March 30. The inauguration was held in the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). SFDA’s Deputy Commissioner, Zhang Jingli, attended the opening ceremony and delivered speeches.