Newsletter – HK and Asia Regulatory

Newsletter – HK and Asia Regulatory
Aug, 09
In This Issue
Number 8
The Regulatory Forum’s roles and successes
Regulatory
Forum’s roles
and successes
The Regulatory Forum, is a regular meeting opens to all companies or
AHWP update
individuals, with the following terms of reference:
Singapore
- To hold regular meetings where medical device experts from different
Forum
regions in Asia can share: good regulatory practice in relation to medical
Hong Kong
devices (and pharmaceuticals); discuss harmonization; and inform
Regulatory
participants of regional regulatory developments; and
Forum
- To provide updates on AHWP matters from both industry and government
Communication
AHWP
representatives via the Regulatory Forum newsletter, which is
skill sharing
distributed to more than 5,000 readers globally. Its content is published in a
China
Regulatory
number of leading industry magazines, including Clinica World Medical
Forum
Technology News, The Regulatory Affairs Journal, The Journal of Medical
Regulatory
Device Regulation, The China Medical Journal, Clinivation and The
Training
Medical Device Manual.
Special Offers to
Forum
Previous Forum newsletters can be downloaded from the following link:
participants
www.bsiamerica.com/HongKongRegForum
Convener Contact
Meetings
The Regulatory Forum holds a number of meetings throughout Asia each
year. The participation of forum is free of charge.
Jack Wong
2008 Forum Schedule
18 Jan HK, 28 Mar HK, 4 Sept Taiwan, 1 Oct Vietnam, 7 Oct Thailand, 16-17
Oct London, 28 Nov HK, 3 Dec China (SZ)
AHWP Hong Kong
representative
Email:
2009 Forum Schedule
22 Jan HK, 20 Feb Thailand, 24 Apr HK, 29 Apr India, 18 May Saudi Arabia,
28-29 May Singapore, 10 Jul China (Beijing), 24 Jul HK, 17 or 18 Sept China
(SZ), 21 Oct UK, 27 Nov HK, 2 Dec UK
jack.wong@bsigroup.com
* Please contact Jack Wong if you would like to participate in any of these
forums
AHWP Annual meeting update
(Please reserve 4-7 Nov 09)
The Forum serves as the platform for AHWP representatives to update Asian
regulatory issues. AHWP is the key regional regulatory group among
regulators and industries to harmonize and share good regulatory practices in
Asia
Our coming annual AHWP meeting will be held on 4-7 November in Hong
Kong with the following tentative schedule:
Dates: 4-7 November 2009
4 November – AHWP TC meeting
5 November – AHWP Workshop
6-7 November – AHWP meeting
Convener Contact
Venue: Hong Kong Convention Centre
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
Registration details will be announced in Jun 09 in AHWP website
(www.ahwp.info) – please note the website address was changed
The meeting will coincide with the HKTDC [Hong Kong Trade Development
Council] Hong Kong International Medical Devices and Supplies Fair, which
is scheduled for 4-6 November 2009.
Speakers confirmed
Dr. Ginette Michaud Center for Devices and Radiological Health, Food and
Drug Administration, USA (Chair of GHTF SG1)
SG1 Update
Ms Isabelle Demade
(Chair of GHTF SG2)
Mr Gunter Frey
Principal Administrator, European Commission
SG2 Update
Senior Auditor, Philips Healthcare SG3 Update
Ms. Jan Welch
Food and Drug Administration, Center for Devices and
Radiological Health, USA (Chair of GHTF SG4)
SG4 Update
Mr Greg LeBlanc Manager, Regulatory Affairs and Quality Systems, Cook
( Canada) Inc., Canada (Vice-Chair of SG5)
SG5 Update
Mr Jeffrey Gren
APEC Project Overseer and Director, Office of Health
and Consumer Goods, U.S. Department of Commerce
AHWP-APEC
Collaboration
Regulatory Forum in Singapore
A Regulatory training on GDP and forum was conducted in
Singapore on 28-29 May 2009
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
GDPMDS (Good Distribution Practices for Medical Devices) aims
to ensure product quality is maintained during storage and
distribution. It acts as a standard to meet the above requirement
and applies to storage practices such as Pest control, adequate
storage areas, appropriate storage conditions, good storage
practices (eg, EEFO – Earliest Expiry First Out) and proper
documentation and records.
BSI Singapore is amongst one of the Certification Body that has
been awarded by Singapore Accredited Council (SAC) to provide
certification for Good Distribution Practices for Medical Devices
(GDPMDS).
BSI Singapore office had successfully conducted “GDPMDS
Sharing Seminar” with many companies that are interested in the
application for certification to join and share their feedback and
experience.
Any company that has activities of importing or does wholesale of
medical devices and wishes to apply for the Import or Wholesale
license is required by law (under the Health Products Act – in
2007) needs to be certified to GDPMDS standard.
The intent of standard is to ensure quality of medical devices is
maintained throughout distribution chain.
Stakeholders involved include: Your company (and any
outsourced activities, eg 3rd party logistic), Health Science
Authorities, Singapore Accreditation Council (SAC), and
Certification bodies (e.g. BSI)
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
GDPMDS auditable standard is known as:
TS-01 Good Distribution Practice of Medical Devices
Requirements (Rev 1)
Simplicity of the documentations – depend greatly on:
- Size and structure of organisation
- Processes
- Type of medical devices
Have to justify any exclusion clause of TS-01 in the Site
Master File.
What is Site Master File?
Site Master File is a summary of requirements by the standard
that includes information such as: scope of activities implemented,
summary of procedures, and information about the premises.
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
Summary of Procedures
•
Site Master File (clause 2.2.2)
–
Introduction to GDPMDS
–
Quality Management system
–
Resource management
–
Storage and stock handling
–
Traceability
–
Product Complaint
–
Field Safety Corrective Action
–
Returns
–
Disposal
–
Counterfeit Devices
–
Internal Audits
–
Management Review
–
Outsourced Activities
Please also note there are 12 product categories for GDPMDS
application:
1.
Active implantable devices
2.
Anesthetic and respiratory devices
3.
Dental devices
4.
Electro mechanical medical devices
5.
Hospital Hardware
6.
In vitro diagnostic Devices
7.
Non-active implantable devices
8.
Ophthalmic and optical devices
9.
Reusable instruments
10. Single-use devices
11. Technical aids for disabled persons
12. Diagnostic and therapeutic radiation devices
For further clarification or assistance required for GDPMDS, you may like to contact
Carol Sim, at carol.sim@bsigroup.com or +65 9749 2832.
Hong Kong Regulatory Forum Update
1. The LRP Panel update (Free LRP membership)
A priority discussion of the forum was Hong Kong’s new Local Responsible
Person (LRP) regulation. The Regulatory Forum’s dedicated LRP Panel
(established in June 2008 to facilitate communication among LRPs, CABs
and the Medcial Device Control Office and to share LRP best practice)
discussed this issue with attendees.
Details about the new LRP requirements can be found at the following link:
http://www.mdco.gov.hk/english/mdacs/mdacs_gn/files/cop_01_1sep2005.pdf
We were also very honoured to have Mr Camon Sin of Medtronic (Hong
Kong) as Chairman. Ms Carman Lai (Hospira) was appointed as Vice-Chair.
Ms Tammy Wong was appointed as Secretary, Ms Monita Lau was
appointed as Legal Advisor, Jack Wong was appointed as Convener
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
Mr Camon Sin (Chair of HK LRP Panel)
The several key discussions in the last LRP Panel meeting on 19th June
2009 were presented:
1) Role of LRP Panel
2) Appointment of Ms. Tammy Wong as the Panel Secretary
3) Key industry issues * indemnification clause in the GN-1 & COP-01
* SME compliance capacity
* LRP QMS
* Fee for product listing
* Class I listing
* Product renewal
* Change of Particulars
* "Accessories" in product listing certificate
* Grace period upon mandatory MDACS
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
The Panel decided to identify the key priorities to focus on in the coming year.
This will be discussed in the next meeting tentatively on 29th September
2009 based on the principle of Panel meeting on a quarterly basis. After the
urge for more industry members to join the Panel, a number of applications
were collected at the end of the Forum and several queries were received
from industry members who are interested in serving as Vice-chairs of the
Panel.
Next LRP meeting
Date:
Oct 8, 2009 (Thurs)
Time:
10:30 am to 1pm
Venue: Conference Room of Medtronic Hong Kong, 16/F Manulife Plaza,
33 Hysan Road, Causeway Bay
Guest of honor: Mr. Mark Lau, MDCO
LRP membership form and Regulatory Forum registration will be jointed
together and emailed to participants
2. HKAPI update
Sabrina Chan (from Hong Kong Association of Pharmaceutical Industry)
provided updates on pharmaceutical regulatory issues
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
Potential new requirement of microbial testing in Hospital
Authority
1. Proof of compliance to microbiological test requirements
a.
Sterile Product: Proof of sterility through evidence shown on product
b.
Non-sterile Product: Proof of compliance to microbiological test requirements
of BP, USP, or EP
2.
a.
b.
More routine sample testing:
Testing method: ID and Assay, microbiological testing
Frequency: increased and routine with schedule
3.
Supply of batch release reports
4.
a.
Additional Information on delivery note
Registration particulars: eg. registration numbers, expiry date…
5.
Multi-sourcing
6.
A valid Check and Chase system – supply chain logistics
Product Classification service
Please note Hong Kong Department of Health has stopped classification
service for pharmaceuticals.
* Message from BSI
Please contact BSI if you need Classification service from third parties
3. Macau Regulatory
HKMRS (Hong Kong and Macao Regulatory Service Limited) is a HK
consultancy company providing regulatory services to clients in HK and
Macao.
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
In additional to regulatory services for pharmaceutical products and
medical devices, HKMRS also provide other services including
Intellectual Property Rights protection and registration.
Regulatory Forum invited Mr. Luciano Baptista to share his experience
on IP protection in conjunction with regulatory registration. There is a
possibility even though registration with local health authority had
been completed, the license holder may not be able to sell his products
because of possible trademarks or patents restrictions. Mr. Baptista
also mentioned 3 points of interest:
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
1. As IP protections are territorial, registration has to be done in
different countries in order to secure the clients' interest.
2. Registration of trademarks has a duration, renewal is required in
order to have continuous protection.
3. There are also different requirements in different countries,
research maybe needed to ensure registration process to be smooth
and expediously.
Mr. Baptista could be reach via the following address:
luciano@hkmrs.com
4. Working with the Media
Veronica Sze (APCO Worldwide) was invited to share their experience
on “ Working with the Media”
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
Understanding the current media eco-system and trends is essential to
furthering your company’s reputation. The internet, including social
media, has replaced print as the driver of media deadlines, agendas and
content. As a result, competition among all other media categories has
intensified, and media outlets and reporters from all types of media
have been forced to further define their scope, depth and agenda.
As the structure of media has changed, so has the nature of reporters
and the way they relate to corporations. Expect for your stories, good
and bad, to be covered by the media. How you interact with reporters
and respond to their inquiries will determine the tone, length and
duration of the coverage.
“No comment” is no longer an acceptable response and timely, direct
responses are expected. Personalize your messages to the type of media
and reporter and communicate proactively when appropriate. Longterm relationships with reporters are critical to building your
reputation with your key audiences.
5. Hong Kong Regulatory update
Convener Contact
Jack Wong
AHWP Hong Kong
representative
Email:
jack.wong@bsigroup.com
Raymond Poon and Jennifer Mak from Medical Device Control Office (Department
of Health) and Jack Wong (BSI) provided the following updates
-
AMDN (Asia Medical Device Nomenclature) was developed in HK and will be
used to replace GMDN or UMDN for registration in HK. There is a plan to
promote the use of AMDN in Asia through AHWP
-
New application form for medical device listing was announced and company
are recommended to use the new form
-
For major product changes, companies are required to inform MDCO about
the changes. BSI would suggest companies to inform MDCO on all the
changes on the documentation submitted to MDCO before
-
MDCO is working on the proposal on how to do Class I listing and LRP
Quality System requirement and plan to roll out around end 09 for comment
Melissa Monson, one of our previous speakers, is sharing tips with a regular column
“Communicating Effectively.” Hope you find it helpful. - Jack Wong
C o m m u n i c a t i n g E ff e c t i v e l y :
A n I P O In Yo u r Fu t u re ?
b y Me l i s s a Mo n s o n
The Initial Public Offering (IPO)* market while still in the doldrums in the US
is doing quite well in China. Both private equity and venture backed firms
went public in the second quarter of this year and were listed on either the
Hong Kong or New York Stock Exchange. Likewise in India where after a nine
month slump companies and their investment bankers are lining up a series of
IPOs to take advantage of increasing international interest to tap into the
Indian market.
If there is a possible IPO in your company’s future, and you are waiting for the
IPO market to turn around, take advantage of this time to learn about the
process for taking your company public.
Start by assembling an experienced team of investment bankers, attorneys and
accountants. Then you’ll write a prospectus; and finally you’ll take your roadshow
to brokers and institutional investors in designated cities around the world.
Preparation Is Critical
Going public entails making one of the most important series of presentations
in your company’s history - one that involves selling your company to a wary
public for the first time. You must ensure that your key people are prepared to
give a well thought-out, clearly focused, enthusiastic presentation from start to
finish every time.
But most management teams are unprepared to tell and sell their company
story. They are inexperienced at developing and delivering a succinct presentation outlining the company’s investment potential complete with a winning
presentation which must be delivered in 20 to 30 minutes.
(continued on pg. 2)
www.monsoncommunications.com
|
melissa@monsoncommunications.com
|
cell: 415.297.8100
copyright © Melissa Monson, 2009
C o m m u n i c a t i n g E ff e c t i v e l y : A n IP O In Yo ur Futu re?
b y Me l i s s a Mo n s o n
(continued from pg. 1)
Drafting the Roadshow
Creating text and visuals for a roadshow begins with a drafting session and then
the story is refined over the course of three to four weeks. The final story must
be compelling and easily understood.
Using Effective Visuals
You must support your company story with a visually clean, simple, easy-tounderstand and a professionally produced presentation that can explain a
complicated technology or multi-product company.
Delivering the Presentation
- Can you synthesize and articulate the most important elements of
your company’s investment story?
- Can you speak energetically and use eye contact?
- Are you comfortable in a stand up presentation?
- Does anyone on your team have an accent that could create
communication problems?
- Do you have carefully crafted answers for that
all-important Q&A session?
Go for it!
With coaching your team should deliver a relaxed, informative, crisp and persuasive
presentation that will motivate potential investors to invest with you.
And, remember, a sharp presentation can boost the offering price!
* A company’s first sale of stock to the public. Securities offered in an IPO are often but not always
those of young small companies seeking outside equity capital and a public market for their stock.
capitalizing your message in global markets.
ROADSHOW PRESENTATIONS. MARKETING. PUBLIC RELATIONS. Melissa Monson is based in
San Francisco, California. She develops roadshows, and coaches management teams who are raising equity in
the private and public markets. She writes the column “Communicating Effectively” for the Hong Kong
Regulatory Forum and was a guest speaker in November 2008.
www.monsoncommunications.com
| melissa@monsoncommunications.com
| cell: 415.297.8100
copyright © Melissa Monson, 2009
China Regulatory Forum
(18 Sept 2009 open for registration)
Further to the success of China Regulatory Forum last year, we would like to
arrange a regular communication platform among government and industry.
Next China Forum detail is as follow:
Date and time:
18 Sept 2009
2:30-5:00pm
Venue:
It will be in Shenzhen China (exact venue to be confirmed by SZ FDA)
Tentative agenda:
AHWP and Asia Regulatory update - by BSI (Secretariat of AHWP)
HK Medical Device Regulatory update - by HK Medical Device Control Office
SZ/China Medical Device Regulatory update - by SZ FDA
Report of last China Forum can be found in the following link
http://www.bsiamerica.com/upload/MS-Assessment+Certification/SubjectAreas+Sectors/Healthcare+Medical-Devices/Documents/HK_CAB/HKRFNewsletter-Nov08.pdf
Pictures of last China Forum
Registration and Query
Email name, title, company name and email address to
jack.wong@bsigroup.com
Regulatory Trainings
BSI is the leader in providing regulatory trainings. Please find
below the courses for your information:
Hong Kong Medical Device and LRP Certificate
Hong Kong Pharmaceutical Regulatory Certificate
China and Global Regulatory Certificate
* These are the first certification course in HK and China
Hong Kong Medical Device Regulatory and LRP
Certificate
(next one is 2-3 Nov)
Hong Kong Department of Health (MDCO) shared experience on LRP requirements. MDCO
may check their legal entities, distribution records, technical documentations, promotional
materials compliant with the UMAO (Undesirable Medical Advertisement Ordinance), labeling
compliance, special listing information, the process and implementation of all the required
SOP submitted to MDCO. MDCO may also collect products from market to conduct
inspections or testings.
LRP training syllabus
A LRP training was developed based on a syllabus agreed by MDCO and CABs as follow:
MDACS and MDCO introduction
Basic medical device regulatory
- definition of medical device
- medical device classification
- tracking of specific medical devices
- special listing information
- Obligation of LRP
- UMAO
- Pharmaceutical product definition and regulatory requirement in HK
Product knowledge on intended uses and contra-indication
Preparation for application submissions
Practical session
- Distribution record SOP implementation
- Complaint handling SOP implementation
- Maintenance and services arrangements SOP implementation
- Product alert, modifications and recall SOP implementation
- Adverse event reporting SOP implementation
- Prepare for MDCO audit
Others
- AHWP, GHTF introduction
- Basic ISO 9000 and 13485 understanding
st
Base on the above syllabus, the 1 LRP training was organized on 25-26 Nov 08 and we
have training every 3-4 months. The next one is 2-3 Nov 09 in Hong Kong
A list of students who passed the exam was published in the newsletter (please refer to later
part of the newsletter)
Pharmaceutical Regulatory Certificate
(next one is 14 Oct)
After discussion with the HK PDA (Hong Kong Pharmaceutical Distributors
Association) and Department of Health (Pharmaceutical Section) a
Regulatory certificate training was developed. The coming training is 3 Jun,
Tina Yap (chair of HKPDA) and Anthony Chan (Chief Pharmacist of DOH) will
attend and give opening speech
Details of the training course can be found below
Regulatory Certificate Program
Date: 3 June (10:30am-4pm)
Why attend?
Regulatory is critical to your business (Quicker and Quality registration
approval means significant competitive advantage) and fatal to your business
(Regulatory requirement is legal requirement, non-compliance means penalty
and imprisonment)
Topics to be covered:
10:30am - 12:30am
Roles/Values of industry/Distributor (to be presented by HKPDA)
What are pharmaceutical products
What product needs to be registered and how to do classify them
Whom to deal with and how to work with government
What materials need to be submitted and why they are required
How to review the material before submission
1:30pm - 3:30pm
What to do if DOH raised questions
How to manage regulatory projects
How to do handle product recalls and re-labelling
UMAO understanding
3:30pm - 4:00pm
A 30mins examination will be arranged at the end
* Certificates will be issued to participants who passed the exam
Next training
Next one is on 14Oct. Please contact Jack Wong if more detail is required
China and Global Medical Device Regulatory
Certificate
(Coming one is 16-17 Sept)
Date: Sep 16-17th, 2009
Venue: Number 7001. Beihuan Avenue.Futian District .Shenzhen
Why attend?
Regulatory function is vital to business. Late registration or late renewal could create
significant business impact. Regulatory regulation is also keep on changing. In the
past, there is no formal regulatory training certificate in Asia.
We work with different regulatory experts globally and proudly create the FIRST
Regulatory Affairs Certificate in China. This certificate program is designed for
regulatory, commercial and quality staff
Medical Device business is getting global and hence this training will not only cover
China regulatory but also key countries globally.
Not only acquiring knowledge, BSI would like to create a platform for regulatory
staff to gather regularly to build stronger regulatory network
BSI will also share some key regulatory processes experiences e.g. how to manage
regulatory projects, how to handle product recalls etc
Topics to be covered:
Introduction of GHTF and AHWP
What is medical device
How to classify medical device
Basic 9000 and 13485 introduction
US and Europe medical device regulatory
Asia medical device regulatory and trend (Japan, Korea, India, Hong Kong,
Taiwan, Singapore, Malaysia, Thailand, Philippines etc)
Fee
RMB 4,800 per person
Language
English and Mandarin
Certification
Certificate will be issued to participants who passed the exam
Training registration or query
Jack.wong@bsigroup.com
vivian.lim@bsigroup.com
* 2 SZ FDA staff confirmed attendance of the above Certificate course on 16-17
Sept
全球医疗器械法规证书课程
亚洲地区首个医疗器械法规资质证书课程
一把打开全球各个国家医疗器械市场的金钥匙
时间:
时间 2009年9月16-17日
地点:
地点 深圳市北环大道7001号开元大厦(景田北), 实华酒店
课程背景：
课程背景：
符合法规的要求对于医疗器械行业是商业成功的核心关键。注册的拖延和更新的拖延
会对业务产生重大的影响，各个国家的法规又处于持续的变化之中，而亚洲地区至今未有任何
机构可以提供全面的法规培训及颁发正式的法规培训资质证书。
BSI和全球各个国家的法规制定机构、法规执行机构及法规专家合作，很荣幸地在中国
设立了首个法规资质证书课程。该证书课程专为法规人员，商务人员和质量人员量身定制。
医疗器械是全球化产业，该培训课程将不仅覆盖中国的法规还囊括全球主要国家法规
内容。除获取知识外，BSI还将搭建一个平台，供法规人员定期交流以提供强有力的法规数据
库及信息分享网络。BSI还将和您分享大量的实践案例，从中帮助您学习一些关键的合规经
验，例如：如何管理法规项目，如何处理产品召回等。
主要议题
GHTF和AHWP简介
什么是医疗器械
医疗器械如何分类
ISO9001和ISO13485简介
美国和欧洲医疗器械法规
亚洲医疗器械法规和趋势（日本，韩国，印度，香港，台湾，新加坡，马来西亚，泰国，菲利
宾等）
费用
RMB 4,800元/人
语言
英语和普通话
证书
通过考试的学员将颁发法规培训证书
如需查询
Jack.wong@bsigroup.com
vivian.lim@bsigroup.com
* 2 SZ FDA staff confirmed attendance of the above Certificate course on 16-17
Sept
Others and Special Offers to Forum participants
1. JMDR special offer to Regulatory Forum participants
Journal of Medical Device Regulation offers special pricing to forum
participants. Please use the code “HK0808” code when making an order
Details can be found at the later part of newsletter
2. Special offer to Regulatory Forum participants from Medical Device
Manual
The Medical Devices Manual is a practical, comprehensive guide for all those
working with medical devices. Euromed Communication is offering a Special
Offer £200 (original price £290) for Regulatory Forum participants. An order
form can be found at the later part of newsletter
3. Clinivation WorldView special offer to Regulatory Forum participants
Clinivation WorldView is the medical device and diagnostic industry's most
comprehensive, authoritative, and up-to-date enterprise solution for OnDemand Global Regulatory Intelligence. Providing clear, step-by-step market
clearance regulations, processes, and guidance for >99% of the world
markets, only Clinivation WorldView delivers tried-and-true intelligence from
certified, practicing professionals with real-world experience
BSI is also a subscriber of Clinivation WorldView and partner for Asia
promotion. Please contact Jack Wong (jack.wong@bsigroup.com) for special
Forum pricing. Detail of the WorldView can be found at the later part of
newsletter
4. Hong Kong Medical Fair’s special offer to Regulatory Forum
participants
All new exhibitors can enjoy a 5% first-time exhibitor discount while overseas
exhibitors (excl. Taiwan, mainland China and Macau) can enjoy 3-night
accommodation (1 room) at a designated hotel.
Details can be found at the later part of newsletter
5. London Regulatory Conference’s special offer to Regulatory Forum
participants
10% discount will be offered to Forum participants
Details can be found at the later part of newsletter
* Email Jack (jack.wong@bsigroup.com) if you do not want to receive this newsletter
Students completed the
Medical Device Regulatory training
Name
Organization
Ricky Ho
Susan Leung
William Ku
Deborah Kwong
Carol Chen
Ivy Kwok
Petty Fan
Gloria Poon
Mr. Cheney Lu
Flora Lee
Jo Choi
Manson Chung
Catherine Cheng
Maggie Leung
Christine Tsai
James Fan
Mandy Yau
Cecilia Chan
Leung, Man Cho
Fong, Yui Kau
Mok, Siu Man Shirley
Chan, Ka Yan
Chan, Yat Hei
Leung, Man Cho
Winki Ip
Audrey Shum
Dr Francis Kua
Mr K K Chow
Fatima Lai
Olivia Chan
Vissica Wong
Martha Lee
Lawrence Yiu
Kayley Wong
Sabrina Chan
Jenny Wan
Mr CHIU Chi-Sang (LUCIANO BAPTISTA)
K C Lee
Carmen Lai
Pandora Cheung
Maggie Ho
Jenny Ho
Frederic Campana
Doris Cheng
Janice Wei
Alcon
Asia Cardiovascular Products Ltd
Asia Cardiovascular Products Ltd
BD
BD
BD
BD
Baker & McKenzie
Baker & McKenzie
Bayer HealthCare Ltd
Bayer HealthCare Ltd
Bayer HealthCare Ltd
Bayer HealthCare Ltd
Boston Scientific
Boston Scientific
Boston Scientific
Baxter Healthcare Ltd
British Consulate General
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Clifford Chance
Constraint Management Center
Constraint Management Center
Consulate General of Canada
Dentsply
Dentsply
DKSH
DKSH
Ferring Pharmaceuticals
HKAPI (HK Association of Pharmaceutical Industry)
HKAPI (HK Association of Pharmaceutical Industry)
HKMRS (Hong Kong and Macau Regulatory Service) Ltd
Hong Kong Standards and Testing Centre Limited
Hospira Ltd
InvestHK
Janssen Pharmaceutical
Johnson & Johnson Medical
LNE Shanghai
Medtronic
Medtronic
Emily Chiang
Jessie Wong
Erica Poon
Sun Qin
Monita Lau
Edgar Leung
Iva Ng
Carin Ribbesjö-Lundqvist
Fanny Wong
Ulf Lundqvist
Ronald Lo
Abdulielah. K . Al-Mutairi
KHALIL .H . AL GHAMDI
AMJAD . S .ALGHAMDI
Faisal . A . Alshehri
Ziad. F. Alsabelah
ALI . M .ALHAWAS
Sultan . A . ALkanhal
HUSSAM . M . ALAEQ
Fahad . H . Al-Mujalli
Abdulrahman . A .Al-Swayed
Majed .A . Al-Qhtani
Felicia Chau
Grace Au
Kamswee Koo
Natalie Yan
Ronan Chan
Cat Hui Yuen Ting
Eddie Ngan
Karen Lee
Tammy Wong
Medtronic
Medtronic
Merck Pharmaceutical
Molnlycke Healthcare
Or & Lau, Solicitors
Orbit Medical Device Company Ltd
OrbusNeich Medical Co Ltd
Q-Med
Q-Med
Q-Med
Roche Diagnostics (HK) Ltd
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Saudi FDA, Saudi Arabia
Siemens Medcial Solutions Diagnostics Ltd
SSL Healthcare
SSL Healthcare
SSL Healthcare
St Jude Medical
St Jude Medical
The MacKay Group
Wyeth
(Freelance Marketing Expert)
Next Medical Device Regulatory training in 2009 is as follow:
2-3 Nov 09
Contact Jack Wong (BSI) for detail of the training:
jack.wong@bsigroup.com
Students completed the
Pharmaceutical Regulatory training
Name
Organization
Vam Cheng
Geoffrey Kok
Rose Mak
Yolanda Yan
Susie Chan
Susanna Leung
Yemmie Tsang
Stanley Yu
Susanna Yim
Mr Cheney Lu
Stephanie Poon
Gloria Poon
Jingyan Wei
Catherine Cheng
Flora Lee
Vivien Lee
Cecilia Chan
Winki Ip
Timothy Chan
Leung Man Cho
Fong Yui Kau
Mok Siu Man
Chan Ka Yan
Chan Yat Hei
Sidney Ng
Keith Kei
Audrey Shum
Fatima Lai
Winnie Chung
Dr Francis Kua
Mr K K Chow
Michael Li
Dominic Chan
Ho Ping Him
Lawrence Yiu
Louisa Ip
Katherine Lai
Agnes Sin
Wendy Cheng
Pang Chuen Yee
Wilson Lun
Sabrina Chan
Jenny Wan
Allergan
Allergan
American Consulate General
Amgen
AMO Asia Ltd
Asia Cardiovascular Products Ltd
AstraZeneca
AstraZeneca
Bausch & Lomb (HK) Ltd
Baker & McKenzie
Baker & McKenzie
Baker & McKenzie
Baker & McKenzie
Bayer HealthCare Ltd
Bayer HealthCare Ltd
B Braun Medical
British Consulate General
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
Chinese University of HK, School of Pharmacy
CK Life Sciences Int'l., Inc.
CK Life Sciences Int'l., Inc.
Clifford Chance
Consulate General of Canada
Consulate General of Canada
Constraint Management Center
Constraint Management Center
CSL Biotherapies Asia Pacific Ltd
Daiichi Sankyo Hong Kong Limited
Daiichi Sankyo Hong Kong Limited
DKSH
Dorsey & Whitney
Ferring
Fresenius Kabi Asia Pacific Ltd
Gakderna Hong Kong Ltd
Hing Wing Co Ltd
Hing Wing Co Ltd
HKAPI (HK Association of Pharmaceutical Industry)
HKAPI (HK Association of Pharmaceutical Industry)
Mr CHIU Chi-Sang (LUCIANO BAPTISTA)
Pandora Cheung
Maggie Ho
Florence Law
Jenny Ho
Kanes Hau
Janet Lai Mei Ho
Chris Kai Cheong Chow
Edgar Shiu Lam Liu
Vincent Wong Ka-Chun
Michael Chan
Doris Cheng
Comte Chan
Vincent Tsui
Emily Lee
Erica Poon
Kane Leung
Daniel Cheung
Suk Chan
Monita Lau
Sophie Li
Corinna Li
Jenny Leung
Anthy Ng
Britta Snackers
Tony Ko
Maria Kong
Tess Yeung
Sean Morley
Raymond Lee
Peggy Yau
Jennifer Lee
Jesscia Chan
Timothy Chan
Quincy Leung
Raccoon Chung
May Yip
Danny Chan
Derek Chow Chun-Pong
Accacia Ku
Karen Lee
Vincci Yip
Calvin Chan
Tammy Wong
Sung Kai-Yi
Eddie Ngan Chiu-Kwong
HKMRS (Hong Kong and Macau Regulatory Service) Ltd
InvestHK
Janssen Pharmaceutical
Janssen Pharmaceutical
Johnson & Johnson Medical
Johnson & Johnson Medical
Lundbeck Hong Kong
Lundbeck Hong Kong
Lundbeck Hong Kong
Mannings
Mannings
Medtronic
Mentholatum Asia Pacific Ltd
Mentholatum Asia Pacific Ltd
Merck Sharp & Dohme
Merck Pharmaceutical
Novo Nordisk Hong Kong Ltd
Novo Nordisk Hong Kong Ltd
Novo Nordisk Hong Kong Ltd
Or & Lau, Solicitors
OrbusNeich Medical (Shenzhen) Co., Ltd.
Reckitt Benckiser Hong Kong Ltd.
Reckitt Benckiser Hong Kong Ltd.
Reckitt Benckiser Hong Kong Ltd.
Sandoz
Servier
Servier
Servier
Starcon Corporation
Stiefel Laboratories (HK) Ltd
Synovate Healthcare
Synovate Healthcare
Takeda
TCM Healthcare (London) Ltd
UCB Pharma Ltd
Watsons
Watsons
Watsons
Watsons
Wyeth
Wyeth
Wyeth
Wyeth
(Freelance Marketing Expert)
(Personal)
(Personal)
Next Pharmaceutical Regulatory Training in 2009 is as follow:
14 Oct, 11 Dec 20 09
Contact Jack Wong (BSI) for detail of the training: jack.wong@bsigroup.com
** SPECIAL OFFER to HK Medical Device
Regulatory Forum Participants **
3 BOOKS FOR THE PRICE OF 2
FAX TO: +44 (0) 1305 770836
Choose any 3 publications from the list below and get the
one with the lowest price for FREE
1.
I would like to order (please tick as appropriate):
Medical Device Regulations in the Americas March 2009 - £165
The US FDA PMA Filing and Approval Experience November 2008 - £49.99
Guidance on the Essential Requirements of the European Medical Devices Directive (MDD) August 2008 - £175
Medical Device Regulatory Requirements in China and Hong Kong June 2008 - £49.99
Medical Device Regulations in Europe (Countries N to Z) April 2008 - £165
Medical Device Regulatory Requirements in Iran February 2008 - £49.99
Medical Device Regulations in Europe (Countries A to M) November 2007 - £165
Reimbursement of Medical Devices in France, Germany, Italy, Spain & the UK October 2007 - £64.99
Key Revisions to the European Medical Device Directive, 93/42/EEC August 2007 - £129.99
Medical Device Regulations in Asia, Africa and the Middle East April 2007 - £165
A Beginners' Guide to the European Medical Devices Directive (MDD) February 2007 - £49.99
A Summary of WEEE Legislation and Compliance in the EU Member States November 2006 - £49.99
2.
Your contact details (please use BLOCK CAPITALS):
Your name:
Mr/Ms/Dr _____________________________________________________________________________
Job title:
_____________________________________________________________________________________
Company:
_____________________________________________________________________________________
Address:
_____________________________________________________________________________________
_____________________________________________________________________________________
Tel:
_____________________________________________________________________________________
Email:
_____________________________________________________________________________________
3.
VAT number:
VAT number: ___________________________________________________________________
All companies located in the European Union will be charged 15% VAT on the rates quoted above unless a valid VAT registration number
is provided (VAT exemption does not apply to UK companies). Companies located outside the European Union will not be charged VAT.
4.
Payment options:
I enclose a cheque for ____________ made payable to ‘Global Regulatory Press’
Please invoice me in:
I would like to pay on-line by credit card. Please send me a secure payment link to use.
5.
Order confirmation
£ (pound sterling)
$ (US dollar)
Signature: _____________________________________________
€ (euro)
Date: __________________________________
All publications are supplied as a PDF by email and all orders are subject to Global Regulatory Press standard Terms & Conditions of Use.
2122Oct
ober2009,Danubi
usHot
elRegent
sPar
k,London
10% di
scount
*f
or
Regul
at
or
yFor
um Par
t
i
ci
pant
s
QUOTECQ7066BD1
Of
f
eravai
l
abl
eunt
i
l18Sept
ember2009
*
of
ft
oppr
i
cet
i
eronl
y
Prepare for your New Legal
Responsibilities
in HK and Asia?
BSI, your regulatory partner in
medical device and pharmaceuticals
Around 2010, many Asian countries including Hong Kong, Malaysia, Singapore and India etc will
have implemented their brand new Medical Device Regulations
BSI (British Standard Institution 英國標準協會) could be your best regulatory partner to help you:
understand the new regulations,
get product and manufacturer certifications quicker,
ensure your SOPs (especially recall SOP) ready,
survive LRP inspection by MDCO, and
more tailor made regulatory services
The link for you to understand the HK regulatory system and download Asia newsletters is:
www.bsiamerica.com/HongKongRegForum
For more information, please contact
Jack Wong
Vice President Regulatory Affairs, Asia; General Manager, Hong Kong, BSI
Email: jack.wong@bsigroup.com