A*STAR, DxD Hub and HSA

Jointly present

Regulatory Framework on Medical Device Development: 2014

Compliance to regulatory guidelines is paramount to the successful commercialization and clinical adoption of developed medical devices. This jointly-organized seminar by A*STAR, DxD Hub and HSA aims to address the questions and concerns from the scientific, clinical and start-up/ SME community regarding the medical device regulatory framework and requirements, especially in the Singapore context. It will also cover common regulatory challenges faced in the industry and possible ways to address them. The session will round off with a segment focusing on awareness training for diagnostic product-specific categories.

This forum brings clinicians, engineers, regulators and industry together to network and engage one another on regulatory concerns. It also aims to provide awareness and a better understanding of the regulatory guidelines and will be especially relevant to researchers and clinicians involved in developing innovative solutions for clinical needs.

Date: 28 November 2014 (Friday)
Time: 9:00 am – 4:30 pm (Registration starts at 8:30am)
Venue: Biopolis, Breakthrough and Discovery Theatrette, Level 4 , Matrix Building

Address: 30 Biopolis Street, Singapore 138671

To register, please click here

ABOUT THE AGENCY FOR SCIENCE, TECHNOLOGY & RESEARCH (A*STAR)

The Agency for Science, Technology and Research (A*STAR) is Singapore’s leading public sector agency that fosters world-class scientific research and talent to drive economic growth and transform Singapore into a vibrant knowledge-based and innovation driven economy.

In line with its mission-oriented mandate, A*STAR spearheads research and development in fields that are essential to growing Singapore’s manufacturing sector and catalyzing new growth industries. A*STAR supports these economic clusters by providing intellectual, human and industrial capital to its partners in industry.

A*STAR oversees 18 biomedical sciences and physical sciences and engineering research entities, located in Biopolis and Fusionopolis, as well as their vicinity. These two R&D hubs house a bustling and diverse community of local and international research scientists and engineers from A*STAR’s research entities as well as a growing number of corporate laboratories.

For more information on A*STAR, please visit http://www.a-star.edu.sg

ABOUT EXPLOIT TECHNOLOGIES PRIVATE LIMITED (ETPL)

ETPL is the technology transfer arm of the Agency for Science, Technology and Research (A*STAR), Singapore’s lead agency for fostering world-class scientific research and talent. As a one-stop resource, ETPL supports A*STAR in transforming the economy through driving innovation and commercializing its research outcomes.

Also known as Exploit Technologies Pte Ltd, ETPL enhances the research output of A*STAR scientists by translating their inventions into marketable products or processes. Through shaping and facilitating licensing deals and spin-offs, ETPL actively engages industry leaders and players to commercialize A*STAR’s technologies and apply them to building ecosystems that benefit business, industry and economy.

For more information, please visit http://www.etpl.sg

ABOUT THE DIAGNOSTICS DEVELOPMENT HUB (DxD HUB)

The Diagnostics Development Hub (DxD Hub) is a national innovation cluster initiative led by A*STAR’s ETPL with the aim of developing and catalysing the growth of Singapore’s diagnostics sector. DxD Hub leverages Singapore’s clinical strengths and existing medical device ecosystem to accelerate the translation of novel diagnostic technologies into market-ready products that address urgent unmet clinical needs in Asia and beyond.

For more information, please visit http://www.etpl.sg/innovation-offerings/diagnostics-development-hub

ABOUT THE HEALTH SCIENCES AUTHORITY (HSA)

The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. As the national blood service, it is responsible for providing a safe and adequate blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice.

For more information about HSA, visit http://www.hsa.gov.sg

For more updates on public health and safety matters, follow us on Twitter at www.twitter.com/HSAsg.
Contact Info : Ms Aileen Yap
Senior Officer, H&L, A*STAR
aileen_yap@a-star.edu.sg

Dr Denise Teoh
Senior Manager, ETPL, A*STAR
denise_teoh@etpl.sg

Date : 28 Nov 2014 8:30 am – 4:30 pm
Venue : Biopolis, Breakthrough and Discovery Theatrette
Level 4 , Matrix Building
30 Biopolis Street, Singapore 138671