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26 Sep 2008
Overview to Clinical Study for Medical & Healthcare Project

Background ­I´º:
In medical & healthcare sector, a lot of the products need to go through some form of clinical study to confer its efficacy, benefits and safety before it can be marketed. These studies can be clinical trial or may be just literature support. Clinical trials can vary in size from a single centre in a single country to multi-centres in multiple countries, especially where there is regional difference. However, the actual requirement and the scale of the study has always been a ¡§mystery¡¨ and difficult to understand by most industry colleagues. The present seminar aims to give an overview on clinical study for the medical industry, in particularly medical device sector, for the project managers, executives, design professionals and company management, so that they can plan their project schedule and resources accordingly.

Objectives ¥Øªº:
To understand the rationale, requirement, design and conduct of Clinical Study
To understand the responsibilities of the study personnel and organisations
To get an overview of project management in multinational trials

If you are interested in join the seminar, please fill in the attached form and return by 24 September, 2008. Should you have enquires, please do not hesitate to contact Ms. Ruth Leung at 27885776 or Ms. Janice Ho at 27885625.

Download: 1086043815.pdf
 
 
 
 
24 Sep 2008
Seminar on Medical Materials Considerations & Applications

The profit margin and potential of medical and healthcare market have attracted many traditional manufacturing firms including those in the field of plastics / metals / electronics / machinery / molding, to consider diversification into this industry. However, there are challenges along the way to success, such as selection of raw materials to comply with stringent regulations, safety and cleanness assurance of the products, requirements for highly precise manufacturing process, etc. This seminar will give an overview on:

The basic differences between medical grade and non-medical grade materials, e.g. difference in price, performance
How to select medical grade materials for medical devices during design and development stage? Any restrictions on additives?
Any special requirements for manufacturing process? Any special requirements need to be met?
Biocompatibility and testing of materials in medical applications

If you are interested to join the seminar, please fill in the attached enrollment form and send back by fax to: Ms Janice Ho, HKMHDMA at Fax No. 2788 5522 on or before 19th September 2008 (Friday).

Download: 591709804.pdf
 
 
 
 
12 Sep 2008
Regulatory Workshop Series ¡V Listing of Medical Devices

Regulation of medical device is an essential method by which government bodies assure that medical devices marketed to the public are safe and efficacious. The Government of HKSAR established the Medical Device Control Office (MDCO) in 2004 with the goal of ensuring the public timely access to medical devices that are safe, efficacious, and perform as intended. In furthering such goals, MDCO is cognizant to avoid placing unnecessary burden on the trade by using a risk-based regulatory approach, which imposes higher regulatory requirement for medical devices of higher risks. The currently operating Medical Device Administrative Control System (MDACS) is a voluntary system under which importers, local manufacturers and certain medical devices are listed. In conjunction, the Government of HKSAR is also preparing to submit to the Legislative Council a statutory framework to regulate medical devices.

The Hong Kong Medical and Healthcare Device Manufacturers Association (HKMHDMA), being the only medical device sector specific association in Hong Kong, has taken up the role to understand, monitor and communicate to our members the regulatory approach of the Government of HKSAR. In addition, we have also responded to many of MDCO¡¦s consultations on various components of MDACS and its Regulatory Impact Assessment.

The purpose of the Regulatory Workshop Series is to create a platform by which HKMHDMA discusses Medical Device Regulatory and Compliance issues among our members, interested parties and MDCO.

Under the risk-based approach of regulating medical devices, each medical device is classified into one of four classes. The premarket and post-market control of each type of device is accordingly different. The purpose of this Workshop is to discuss among our industries with participation of Medical Device Control Office of Department of Health
The status of Listing of Medical Devices in Hong Kong
Industries¡¦ view of the regulatory framework and practice
Strategies or methods to maintain or improve efficiency in Listing applications.

If you are interested in join the seminar, please fill in the attached form and return by 10 September, 2008. Should you have enquires, please do not hesitate to contact Dr. Christopher Chan at 27885514 or Ms. Janice Ho at 27885625.

Download: 743674417.pdf
 
 
 
 
09 Sep 2008
MEDTEC China September 9-11, 2008 at INTEX Shanghai

MEDTEC China showcases a full range of sophisticated technologies and innovations for medical device design and manufacturing. Grasp the most-updated global market intelligence in enhancing the production standard, quality and efficiency to capitalize the enormous market potentials.
For more information: WWW.MEDTECCHINA.COM.

A high profile conference featuring the hottest topics in the market will be held concurrently. Notable speakers including USFDA, SFDA, and Shanghai FDA will give the latest update on regulatory issues, risk management, GMPs, innovative technologies during the 3 show days.
For the full conference program, please visit the following website, (http://www.devicelink.com/expo/shanghai08/conference_program.html).

HKMHDMA members can enjoy an exclusive discount rate to attend the conference.
(1 complimentary conference ticket of the same value to HKMHDMA for any 3 tickets sold to HKMHDMA members)

If you are interested to attend the conference, please fill in the attached conference registration form and return by August 18, 2008. Please do not hesitate to contact Dr Chris Chan by phone at 27885514 or Janice Ho at 27885625 or fax at 27885522.


Download: 1790948259.pdf
 
 
 
 
02 Jun 2008
Regulatory Workshop Series ¡V Overview of Hong Kong Government¡¦s Medical Device Regulatory Approach

Regulation of medical device is an essential method by which government bodies assure that medical devices marketed to the public are safe and efficacious. The Government of HKSAR established the Medical Device Control Office (MDCO) in 2004 with the goal of ensuring the public timely access to medical devices that are safe, efficacious, and perform as intended. In furthering such goals, MDCO is cognizant to avoid placing unnecessary burden on the trade by using a risk-based regulatory approach, which imposes higher regulatory requirement for medical devices of higher risks. The currently operating Medical Device Administrative Control System (MDACS) is a voluntary system under which importers, local manufacturers and certain medical devices are listed. In conjunction, the Government of HKSAR is also preparing to submit to the Legislative Council a statutory framework to regulate medical devices.

The Hong Kong Medical and Healthcare Device Manufacturers Association (HKMHDMA), being the only medical device sector specific association in Hong Kong, has taken up the role to understand, monitor and communicate to our members the regulatory approach of the Government of HKSAR. In addition, we have also responded to many of MDCO¡¦s consultations on various components of MDACS and its Regulatory Impact Assessment.

The purpose of the Regulatory Workshop Series is to create a platform by which HKMHDMA discusses Medical Device Regulatory and Compliance issues among our members, interested parties and MDCO.

If you are interested to join the seminar, please contact, Dr. Christopher Chan, secretariat of HKMHDMA at 2788 5514 or by email at info@medicaldevice.org.hk.

Download: 1568724113.pdf