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13 Sep 2013, 15:00


13 Sep 2013, 17:00

In the past decade the regulatory requirements and customer needs of medical device have become tighter when it comes to quality & safety considerations. Understanding the medical device regulations and requirement is essential especially when companies try to bring new innovative medical products to the market. Such understanding could facilitate the regulatory processes as well as avoid unnecessary lost.

In this seminar, SGS & our guest speakers from the medical field will share the medical devices regulations in major jurisdictions such as United States, Europe and China, products registration and their industry experience.

Seminar Content 

  • Definitions of Medical Device and Product Classification Systems
  • Types of pre-marketing regulatory assessment: product listing, the US 510(k), EU CE-marking, PRC product registration
  • Role of quality systems in medical device regulation/ standards
  • Summary: Roadmap of product approval process
  • Guest sharing on product registration and post market surveillance follow up

Who should attend?
This seminar is designed for medical device manufacturer, distributor, importers, as well as any other SMEs who are interested in the medical device industry

Speaker: Billy Wong, Project Manager (Medical Device) of SGS Hong Kong
Guest Speakers: Representatives from a local registered medical device manufacturer and a multinational medical device company.

Date: 13th Sep 2013 (Friday)
Time: 3:00pm – 5:00 pm
Venue: Room 202, 2/F, First Commercial Bldg, 33-35 Leighton Road, Causeway Bay