In the beginning of the forum, Mr. Jack Wong (VP – Regulatory Affairs, BSI) gave an opening speech and introduced this Regulatory Forum. The forum is a regular meeting open to all companies or individuals with the following terms of reference since 2006.
- Providing Asian Harmonization Working Party (AHWP) updates by AHWP non-government and government representatives
- Maintaining a regular gathering of regulatory and non-regulatory staff in medical device fields, and
- Creating a platform for different trade associations, industries and DOH to discuss and updates the medical device regulatory development in Hong Kong.
The first speaker was Ms. Danielle Giroud (Founder, World Medical Device Organization) and her topic was “ISO 14155 update”.
The standards were shown as follows:
ISO 14155–1:2003 – Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155–2:2003 – Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
Ms. Giroud said ISO 14155 would be updated and the objectives of the revision would clarify outstanding points after 2003 revision and try to reach some harmonization with ICH to improve overall compliance. Moreover, the structure of this revision would merge current part 2 into part 1 as a normative annex A; and it would be more focused on the workflow.
The scope of ISO 14155 is to address good clinical practices (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The revision of the standard added many new definitions such as blinding/masking, comparator, contract research organization, device deficiency … etc. Moreover, safety definitions had significantly changed except for serious adverse event.
In clinical investigation planning, risk assessment is referred to ISO 14971 as the basis for identification of anticipated adverse device effects. The timeline of new vision ISO 14155 was expected to be issued at the end of 2010.
In clinical investigation planning, risk assessment is referred to ISO 14971 as the basis for identification of anticipated adverse device effects. The timeline of new vision ISO 14155 was expected to be issued at the end of 2010.
I (Quality Manager, HKSTP) was the second speaker and my presentation title was “Report from Hong Kong Council for Testing and Certification”.
After the Testing and Certification Industry was identified by the Task Force on Economic Challenges (TFEC) as one of six economic areas, the Hong Kong Council for Testing and Certification (HKCTC) was established on 17 September 2009. The vision of HKCTC is for Hong Kong to develop into a testing and certification hub in the region by reinforcing the branding of “Tested in Hong Kong, Certified in Hong Kong”.
Selected Four Trades were considered good opportunities and they were Chinese Medicine, Construction Materials, Food and Jewellery. Moreover, two Emerging Trades were selected as Environmental Protection and Information & Communications Technologies (ICT).
The most important achievement of HKCTC was to pursue wider recognition by Mainland authorities through CEPA discussion (e.g. China Compulsory Certification (CCC) system). It was just announce to be included in CEPA supplementary document 7 today.
Then I briefed the role of HKSTP laboratories on the testing and certification industry which was recommended by HKCTC. They were:
- Science Park to step up promotion of their facilities available for shared use
- Science Park to facilitate the setting up of testing laboratories with special accommodation needs in IEs where necessary
After that the role of Hong Kong Society for Quality (HKSQ) was also introduced and HKSQ submitted the view summary to HKCTC and participated to Hong Kong Qualifications Framework (HKQF) for testing and certification industry.
The third speaker was Mr. Lewis Huen (Business Development Director – Healthcare, DKSH HK Ltd.) and his presentation entitled “Overview of Global – Consignment Inventory Management System used in the Healthcare Industry”.
Firstly, Mr. Huen briefed some service on echoplus for the healthcare industry included Customer Relationship Management (CRM), Sales Order Management (SOM), Merchandising Management (MM) and Consignment Inventory Management (CIM).
CIM was able to enhance the speed of stock count to reduce the time spent of field force in hospitals and it could directly integrate with SAP ERP to reduce admin workload and enhance accuracy and generate timely reports.
Mr. Huen shared Taiwan experience on CIM and their business solution would be customized for Pharma, OTC/Consumer Healthcare, Medical Devices, Diagnostics, Dental and Optical teams.
The fourth speaker was Mr. Matthew Kopecky (Director of Sales Support, Asia Pacific of Sparta Systems, Inc.) and his topic was “Technology Approaches to Quality Management”
Mr. Kopecky briefed the evolution of quality and some problems of point solutions. And then he introduced an electronic quality management solution (EQMS) included selection criteria, deployment, integration, validation and training.
EQMS was briefed and it helped to validating configurable enterprise architecture. Therefore, initial installation had performed Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). After that any incremental processes needed to execute PQ only.
The next session was HKAPI update, Local Responsible Person (LRP) Panel and MDCO/HA update.
Ms. Sabrina Chan (Executive Director, HKAPI) represented the Hong Kong Association of The Pharmaceutical Industry (HKAPI) for industry update. HKAPI had established since 1968. She said that the mission of HKAPI is to ensure patients have expedient access to innovative and effective drugs to enhance better health and quality of life.
There were 68 members and distributed as follows:
- Full membership: 38 R&D based multinational companies;
- Affiliate membership: 2 R&D based multinational companies with no pharmaceutical product launched in Hong Kong; and
- Associate membership: 28 companies providing services to full members.
One of important update was the implementation of the Pharmaceutical Review recommendation that Department of Health (DOH) would hire more than 70 pharmacists at the stage.
Other updates included:
- The industry supported the first annual symposium on Pharmacovigilance which was organized by CUHK on 18 March 2010.
- Cooperation agreement on the Control of Pharmaceutical Product and Medical Device between SFDA and DH on 24 May 2010.
- HKAPI encouraged clinical trial in Hong Kong. A paper submitted to the Innovation and Technology Commission (ITC) regarding develop Hong Kong as clinical trial centre.
For pharmaceutical industry, there were 4 years transition period to PIC/S (GMP standard) in Hong Kong and 3 years transition period to EMEA standard in China.
Mr. Camon Sin (Director – Greater China in Medtronic and Chair of HK LRP Panel) and his topic was “LRP Panel – An Update on 28th May 2010 at the HKMDRF”.
Mr. Sin updated the last panel meeting on 13th Apr 2010 that Mr. Billy Wong (Vice-chair, LRP Panel) shared his experience on ISO 9001 and ISO 13485. Moreover, LRP Panel Website was established and parked at the Hong Kong Medical Device Regulatory Forum website within BSI Group.
Moreover, two documents were released by MDCO on 23 April 2010 and they were:
- TR-004: Essential Principles of Safety & Performance of Medical Devices
- TR-005: Additional Medical Device Labeling Requirements
Finally, Mr. S.Y. Lam (Sr. Electronics Engineer, MDCO of DOH) updated recently situation and also shared some HR changed in MDCO. He recognized that the regulation forum was good communication channel between industry and regulatory body.
For more information:
Hong Kong Regulatory Forum: http://www.bsigroup.cn/HongKongRegForum
Local Responsible Person (LRP) Panel: http://www.bsigroup.cn/zh-cn/Training/Training-course-areas/Medical-devices/About_LRP_Panel/
World Medical Device Organization: www.wmdo.org
Hong Kong Science and Technology Parks (HKSTP) – Laboratories: www.lab.hkstp.org
Hong Kong Society for Quality (HKSQ): www.hksq.org
HKSQ's suggestions to the testing & certification industry at http://www.hksq.org/news.htm
DKSH Hong Kong Limited: www.dksh.com
Sparta Systems, Inc.: www.spartasystems.com
The Hong Kong Association of The Pharmaceutical Industry (HKAPI): www.hkapi.hk
Medtronic Medical Appliance Technology & Service (Shanghai) Ltd.: www.medtronic.com
Medical Device Control Office of DOH: www.mdco.gov.hk
After the Testing and Certification Industry was identified by the Task Force on Economic Challenges (TFEC) as one of six economic areas, the Hong Kong Council for Testing and Certification (HKCTC) was established on 17 September 2009. The vision of HKCTC is for Hong Kong to develop into a testing and certification hub in the region by reinforcing the branding of “Tested in Hong Kong, Certified in Hong Kong”.
Selected Four Trades were considered good opportunities and they were Chinese Medicine, Construction Materials, Food and Jewellery. Moreover, two Emerging Trades were selected as Environmental Protection and Information & Communications Technologies (ICT).
The most important achievement of HKCTC was to pursue wider recognition by Mainland authorities through CEPA discussion (e.g. China Compulsory Certification (CCC) system). It was just announce to be included in CEPA supplementary document 7 today.
Then I briefed the role of HKSTP laboratories on the testing and certification industry which was recommended by HKCTC. They were:
- Science Park to step up promotion of their facilities available for shared use
- Science Park to facilitate the setting up of testing laboratories with special accommodation needs in IEs where necessary
After that the role of Hong Kong Society for Quality (HKSQ) was also introduced and HKSQ submitted the view summary to HKCTC and participated to Hong Kong Qualifications Framework (HKQF) for testing and certification industry.
The third speaker was Mr. Lewis Huen (Business Development Director – Healthcare, DKSH HK Ltd.) and his presentation entitled “Overview of Global – Consignment Inventory Management System used in the Healthcare Industry”.
Firstly, Mr. Huen briefed some service on echoplus for the healthcare industry included Customer Relationship Management (CRM), Sales Order Management (SOM), Merchandising Management (MM) and Consignment Inventory Management (CIM).
CIM was able to enhance the speed of stock count to reduce the time spent of field force in hospitals and it could directly integrate with SAP ERP to reduce admin workload and enhance accuracy and generate timely reports.
Mr. Huen shared Taiwan experience on CIM and their business solution would be customized for Pharma, OTC/Consumer Healthcare, Medical Devices, Diagnostics, Dental and Optical teams.
The fourth speaker was Mr. Matthew Kopecky (Director of Sales Support, Asia Pacific of Sparta Systems, Inc.) and his topic was “Technology Approaches to Quality Management”
Mr. Kopecky briefed the evolution of quality and some problems of point solutions. And then he introduced an electronic quality management solution (EQMS) included selection criteria, deployment, integration, validation and training.
EQMS was briefed and it helped to validating configurable enterprise architecture. Therefore, initial installation had performed Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). After that any incremental processes needed to execute PQ only.
The next session was HKAPI update, Local Responsible Person (LRP) Panel and MDCO/HA update.
Ms. Sabrina Chan (Executive Director, HKAPI) represented the Hong Kong Association of The Pharmaceutical Industry (HKAPI) for industry update. HKAPI had established since 1968. She said that the mission of HKAPI is to ensure patients have expedient access to innovative and effective drugs to enhance better health and quality of life.
There were 68 members and distributed as follows:
- Full membership: 38 R&D based multinational companies;
- Affiliate membership: 2 R&D based multinational companies with no pharmaceutical product launched in Hong Kong; and
- Associate membership: 28 companies providing services to full members.
One of important update was the implementation of the Pharmaceutical Review recommendation that Department of Health (DOH) would hire more than 70 pharmacists at the stage.
Other updates included:
- The industry supported the first annual symposium on Pharmacovigilance which was organized by CUHK on 18 March 2010.
- Cooperation agreement on the Control of Pharmaceutical Product and Medical Device between SFDA and DH on 24 May 2010.
- HKAPI encouraged clinical trial in Hong Kong. A paper submitted to the Innovation and Technology Commission (ITC) regarding develop Hong Kong as clinical trial centre.
For pharmaceutical industry, there were 4 years transition period to PIC/S (GMP standard) in Hong Kong and 3 years transition period to EMEA standard in China.
Mr. Camon Sin (Director – Greater China in Medtronic and Chair of HK LRP Panel) and his topic was “LRP Panel – An Update on 28th May 2010 at the HKMDRF”.
Mr. Sin updated the last panel meeting on 13th Apr 2010 that Mr. Billy Wong (Vice-chair, LRP Panel) shared his experience on ISO 9001 and ISO 13485. Moreover, LRP Panel Website was established and parked at the Hong Kong Medical Device Regulatory Forum website within BSI Group.
Moreover, two documents were released by MDCO on 23 April 2010 and they were:
- TR-004: Essential Principles of Safety & Performance of Medical Devices
- TR-005: Additional Medical Device Labeling Requirements
Finally, Mr. S.Y. Lam (Sr. Electronics Engineer, MDCO of DOH) updated recently situation and also shared some HR changed in MDCO. He recognized that the regulation forum was good communication channel between industry and regulatory body.
For more information:
Hong Kong Regulatory Forum: http://www.bsigroup.cn/HongKongRegForum
Local Responsible Person (LRP) Panel: http://www.bsigroup.cn/zh-cn/Training/Training-course-areas/Medical-devices/About_LRP_Panel/
World Medical Device Organization: www.wmdo.org
Hong Kong Science and Technology Parks (HKSTP) – Laboratories: www.lab.hkstp.org
Hong Kong Society for Quality (HKSQ): www.hksq.org
HKSQ's suggestions to the testing & certification industry at http://www.hksq.org/news.htm
DKSH Hong Kong Limited: www.dksh.com
Sparta Systems, Inc.: www.spartasystems.com
The Hong Kong Association of The Pharmaceutical Industry (HKAPI): www.hkapi.hk
Medtronic Medical Appliance Technology & Service (Shanghai) Ltd.: www.medtronic.com
Medical Device Control Office of DOH: www.mdco.gov.hk
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