Newsletter – HK and Asia Regulatory - BSI America

Newsletter – HK and Asia RegulatoryAug, 09 Number 8In This Issue RegulatoryForum’s rolesand successes AHWP update SingaporeForum Hong KongRegulatoryForum Communicationskill sharing ChinaRegulatoryForum RegulatoryTraining Special Offers toForumparticipantsThe Regulatory Forum’s roles and successesThe Regulatory Forum, is a regular meeting opens to all companies orindividuals, with the following terms of reference:- To hold regular meetings where medical device experts from differentregions in Asia can share: good regulatory practice in relation to medicaldevices (and pharmaceuticals); discuss harmonization; and informparticipants of regional regulatory developments; and- To provide updates on AHWP matters from both industry and governmentAHWP representatives via the Regulatory Forum newsletter, which isdistributed to more than 5,000 readers globally. Its content is published in anumber of leading industry magazines, including Clinica World MedicalTechnology News, The Regulatory Affairs Journal, The Journal of MedicalDevice Regulation, The China Medical Journal, Clinivation and TheMedical Device Manual.Previous Forum newsletters can be downloaded from the following link:www.bsiamerica.com/HongKongRegForumConvener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comMeetingsThe Regulatory Forum holds a number of meetings throughout Asia eachyear. The participation of forum is free of charge.2008 Forum Schedule18 Jan HK, 28 Mar HK, 4 Sept Taiwan, 1 Oct Vietnam, 7 Oct Thailand, 16-17Oct London, 28 Nov HK, 3 Dec China (SZ)2009 Forum Schedule22 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* Please contact Jack Wong if you would like to participate in any of theseforums

Convener ContactJack WongRegulatory Forum in SingaporeA Regulatory training on GDP and forum was conducted inSingapore on 28-29 May 2009AHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comGDPMDS (Good Distribution Practices for Medical Devices) aimsto ensure product quality is maintained during storage anddistribution. It acts as a standard to meet the above requirementand applies to storage practices such as Pest control, adequatestorage areas, appropriate storage conditions, good storagepractices (eg, EEFO – Earliest Expiry First Out) and properdocumentation and records.BSI Singapore is amongst one of the Certification Body that hasbeen awarded by Singapore Accredited Council (SAC) to providecertification for Good Distribution Practices for Medical Devices(GDPMDS).BSI Singapore office had successfully conducted “GDPMDSSharing Seminar” with many companies that are interested in theapplication for certification to join and share their feedback andexperience.Any company that has activities of importing or does wholesale ofmedical devices and wishes to apply for the Import or Wholesalelicense is required by law (under the Health Products Act – in2007) needs to be certified to GDPMDS standard.

The intent of standard is to ensure quality of medical devices ismaintained throughout distribution chain.Stakeholders involved include: Your company (and anyoutsourced activities, eg 3rd party logistic), Health ScienceAuthorities, Singapore Accreditation Council (SAC), andCertification bodies (e.g. BSI)Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comGDPMDS auditable standard is known as: TS-01 Good Distribution Practice of Medical DevicesRequirements (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 SiteMaster File.What is Site Master File?Site Master File is a summary of requirements by the standardthat includes information such as: scope of activities implemented,summary of procedures, and information about the premises.

Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comSummary 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 ActivitiesPlease also note there are 12 product categories for GDPMDSapplication:1. Active implantable devices2. Anesthetic and respiratory devices3. Dental devices4. Electro mechanical medical devices5. Hospital Hardware6. In vitro diagnostic Devices7. Non-active implantable devices8. Ophthalmic and optical devices9. Reusable instruments10. Single-use devices11. Technical aids for disabled persons12. Diagnostic and therapeutic radiation devicesFor further clarification or assistance required for GDPMDS, you may like to contactCarol Sim, at carol.sim@bsigroup.com or +65 9749 2832.

Hong Kong Regulatory Forum Update1. The LRP Panel update (Free LRP membership)A priority discussion of the forum was Hong Kong’s new Local ResponsiblePerson (LRP) regulation. The Regulatory Forum’s dedicated LRP Panel(established in June 2008 to facilitate communication among LRPs, CABsand 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.pdfWe were also very honoured to have Mr Camon Sin of Medtronic (HongKong) as Chairman. Ms Carman Lai (Hospira) was appointed as Vice-Chair.Ms Tammy Wong was appointed as Secretary, Ms Monita Lau wasappointed as Legal Advisor, Jack Wong was appointed as ConvenerConvener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comMr Camon Sin (Chair of HK LRP Panel)The several key discussions in the last LRP Panel meeting on 19th June2009 were presented:1) Role of LRP Panel2) Appointment of Ms. Tammy Wong as the Panel Secretary3) 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 MDACSConvener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comThe 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 September2009 based on the principle of Panel meeting on a quarterly basis. After theurge for more industry members to join the Panel, a number of applicationswere collected at the end of the Forum and several queries were receivedfrom industry members who are interested in serving as Vice-chairs of thePanel.Next LRP meetingDate:Time:Oct 8, 2009 (Thurs)10:30 am to 1pmVenue: Conference Room of Medtronic Hong Kong, 16/F Manulife Plaza,33 Hysan Road, Causeway BayGuest of honor: Mr. Mark Lau, MDCOLRP membership form and Regulatory Forum registration will be jointedtogether and emailed to participants

2. HKAPI updateSabrina Chan (from Hong Kong Association of Pharmaceutical Industry)provided updates on pharmaceutical regulatory issuesConvener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comPotential new requirement of microbial testing in HospitalAuthority1. Proof of compliance to microbiological test requirementsa. Sterile Product: Proof of sterility through evidence shown on productb. Non-sterile Product: Proof of compliance to microbiological test requirementsof BP, USP, or EP2. More routine sample testing:a. Testing method: ID and Assay, microbiological testingb. Frequency: increased and routine with schedule3. Supply of batch release reports4. Additional Information on delivery notea. Registration particulars: eg. registration numbers, expiry date…5. Multi-sourcing6. A valid Check and Chase system – supply chain logisticsProduct Classification servicePlease note Hong Kong Department of Health has stopped classificationservice for pharmaceuticals.* Message from BSIPlease contact BSI if you need Classification service from third parties

3. Macau RegulatoryHKMRS (Hong Kong and Macao Regulatory Service Limited) is a HKconsultancy company providing regulatory services to clients in HK andMacao.Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comIn additional to regulatory services for pharmaceutical products and

Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.commedical devices, HKMRS also provide other services includingIntellectual Property Rights protection and registration.Regulatory Forum invited Mr. Luciano Baptista to share his experienceon IP protection in conjunction with regulatory registration. There is apossibility even though registration with local health authority hadbeen completed, the license holder may not be able to sell his productsbecause of possible trademarks or patents restrictions. Mr. Baptistaalso mentioned 3 points of interest:1. As IP protections are territorial, registration has to be done indifferent countries in order to secure the clients' interest.2. Registration of trademarks has a duration, renewal is required inorder to have continuous protection.3. There are also different requirements in different countries,research maybe needed to ensure registration process to be smoothand expediously.Mr. Baptista could be reach via the following address:luciano@hkmrs.com

4. Working with the MediaVeronica Sze (APCO Worldwide) was invited to share their experienceon “ Working with the Media”Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comUnderstanding the current media eco-system and trends is essential tofurthering your company’s reputation. The internet, including socialmedia, has replaced print as the driver of media deadlines, agendas andcontent. As a result, competition among all other media categories hasintensified, and media outlets and reporters from all types of mediahave been forced to further define their scope, depth and agenda.As the structure of media has changed, so has the nature of reportersand the way they relate to corporations. Expect for your stories, goodand bad, to be covered by the media. How you interact with reportersand respond to their inquiries will determine the tone, length andduration of the coverage.“No comment” is no longer an acceptable response and timely, directresponses are expected. Personalize your messages to the type of mediaand reporter and communicate proactively when appropriate. Longtermrelationships with reporters are critical to building yourreputation with your key audiences.

5. Hong Kong Regulatory updateConvener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comRaymond Poon and Jennifer Mak from Medical Device Control Office (Departmentof Health) and Jack Wong (BSI) provided the following updates- AMDN (Asia Medical Device Nomenclature) was developed in HK and will beused to replace GMDN or UMDN for registration in HK. There is a plan topromote the use of AMDN in Asia through AHWP- New application form for medical device listing was announced and companyare recommended to use the new form- For major product changes, companies are required to inform MDCO aboutthe changes. BSI would suggest companies to inform MDCO on all thechanges on the documentation submitted to MDCO before- MDCO is working on the proposal on how to do Class I listing and LRPQuality 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 WongCommunicating Effectively:An IPO In Your Future?by Melissa MonsonThe Initial Public Offering (IPO)* market while still in the doldrums in the USis doing quite well in China. Both private equity and venture backed firmswent public in the second quarter of this year and were listed on either theHong Kong or New York Stock Exchange. Likewise in India where after a ninemonth slump companies and their investment bankers are lining up a series ofIPOs to take advantage of increasing international interest to tap into theIndian market.If there is a possible IPO in your company’s future, and you are waiting for theIPO market to turn around, take advantage of this time to learn about theprocess for taking your company public.Start by assembling an experienced team of investment bankers, attorneys andaccountants. Then you’ll write a prospectus; and finally you’ll take your roadshowto brokers and institutional investors in designated cities around the world.Preparation Is CriticalGoing public entails making one of the most important series of presentationsin your company’s history - one that involves selling your company to a warypublic for the first time. You must ensure that your key people are prepared togive a well thought-out, clearly focused, enthusiastic presentation from start tofinish every time.But most management teams are unprepared to tell and sell their companystory. They are inexperienced at developing and delivering a succinct presentationoutlining the company’s investment potential complete with a winningpresentation which must be delivered in 20 to 30 minutes.(continued on pg. 2)www.monsoncommunications.com | melissa@monsoncommunications.com | cell: 415.297.8100copyright © Melissa Monson, 2009

Communicating Effectively: An IPO In Your Future?by Melissa Monson(continued from pg. 1)Drafting the RoadshowCreating text and visuals for a roadshow begins with a drafting session and thenthe story is refined over the course of three to four weeks. The final story mustbe compelling and easily understood.Using Effective VisualsYou must support your company story with a visually clean, simple, easy-tounderstandand a professionally produced presentation that can explain acomplicated technology or multi-product company.Delivering the Presentation- Can you synthesize and articulate the most important elements ofyour 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 createcommunication problems?- Do you have carefully crafted answers for thatall-important Q&A session?Go for it!With coaching your team should deliver a relaxed, informative, crisp and persuasivepresentation 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 alwaysthose 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 inSan Francisco, California. She develops roadshows, and coaches management teams who are raising equity inthe private and public markets. She writes the column “Communicating Effectively” for the Hong KongRegulatory Forum and was a guest speaker in November 2008.www.monsoncommunications.com | melissa@monsoncommunications.com | cell: 415.297.8100copyright © 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 toarrange a regular communication platform among government and industry.Next China Forum detail is as follow:Date and time:18 Sept 20092:30-5:00pmVenue: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 OfficeSZ/China Medical Device Regulatory update - by SZ FDAReport of last China Forum can be found in the following linkhttp://www.bsiamerica.com/upload/MS-Assessment+Certification/Subject-Areas+Sectors/Healthcare+Medical-Devices/Documents/HK_CAB/HKRF-Newsletter-Nov08.pdfPictures of last China ForumRegistration and QueryEmail name, title, company name and email address tojack.wong@bsigroup.com

Regulatory TrainingsBSI is the leader in providing regulatory trainings. Please findbelow the courses for your information:Hong Kong Medical Device and LRP CertificateHong Kong Pharmaceutical Regulatory CertificateChina and Global Regulatory Certificate* These are the first certification course in HK and ChinaHong Kong Medical Device Regulatory and LRPCertificate(next one is 2-3 Nov)Hong Kong Department of Health (MDCO) shared experience on LRP requirements. MDCOmay check their legal entities, distribution records, technical documentations, promotionalmaterials compliant with the UMAO (Undesirable Medical Advertisement Ordinance), labelingcompliance, special listing information, the process and implementation of all the requiredSOP submitted to MDCO. MDCO may also collect products from market to conductinspections or testings.LRP training syllabusA LRP training was developed based on a syllabus agreed by MDCO and CABs as follow:MDACS and MDCO introductionBasic 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 HKProduct knowledge on intended uses and contra-indicationPreparation for application submissionsPractical 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 auditOthers- AHWP, GHTF introduction- Basic ISO 9000 and 13485 understandingBase on the above syllabus, the 1 st LRP training was organized on 25-26 Nov 08 and wehave training every 3-4 months. The next one is 2-3 Nov 09 in Hong KongA list of students who passed the exam was published in the newsletter (please refer to laterpart of the newsletter)

Pharmaceutical Regulatory Certificate(next one is 14 Oct)After discussion with the HK PDA (Hong Kong Pharmaceutical DistributorsAssociation) and Department of Health (Pharmaceutical Section) aRegulatory certificate training was developed. The coming training is 3 Jun,Tina Yap (chair of HKPDA) and Anthony Chan (Chief Pharmacist of DOH) willattend and give opening speechDetails of the training course can be found belowDate: 3 June (10:30am-4pm)Regulatory Certificate ProgramWhy attend?Regulatory is critical to your business (Quicker and Quality registrationapproval means significant competitive advantage) and fatal to your business(Regulatory requirement is legal requirement, non-compliance means penaltyand imprisonment)Topics to be covered:10:30am - 12:30amRoles/Values of industry/Distributor (to be presented by HKPDA)What are pharmaceutical productsWhat product needs to be registered and how to do classify themWhom to deal with and how to work with governmentWhat materials need to be submitted and why they are requiredHow to review the material before submission1:30pm - 3:30pmWhat to do if DOH raised questionsHow to manage regulatory projectsHow to do handle product recalls and re-labellingUMAO understanding3:30pm - 4:00pmA 30mins examination will be arranged at the end* Certificates will be issued to participants who passed the examNext trainingNext one is on 14Oct. Please contact Jack Wong if more detail is required

China and Global Medical Device RegulatoryCertificate(Coming one is 16-17 Sept)Date: Sep 16-17th, 2009Venue: Number 7001. Beihuan Avenue.Futian District .ShenzhenWhy attend?Regulatory function is vital to business. Late registration or late renewal could createsignificant business impact. Regulatory regulation is also keep on changing. In thepast, there is no formal regulatory training certificate in Asia.We work with different regulatory experts globally and proudly create the FIRSTRegulatory Affairs Certificate in China. This certificate program is designed forregulatory, commercial and quality staffMedical Device business is getting global and hence this training will not only coverChina regulatory but also key countries globally.Not only acquiring knowledge, BSI would like to create a platform for regulatorystaff to gather regularly to build stronger regulatory networkBSI will also share some key regulatory processes experiences e.g. how to manageregulatory projects, how to handle product recalls etcTopics to be covered:Introduction of GHTF and AHWPWhat is medical deviceHow to classify medical deviceBasic 9000 and 13485 introductionUS and Europe medical device regulatoryAsia medical device regulatory and trend (Japan, Korea, India, Hong Kong,Taiwan, Singapore, Malaysia, Thailand, Philippines etc)FeeRMB 4,800 per personLanguageEnglish and MandarinCertificationCertificate will be issued to participants who passed the examTraining registration or queryJack.wong@bsigroup.comvivian.lim@bsigroup.com* 2 SZ FDA staff confirmed attendance of the above Certificate course on 16-17Sept

全 球 医 疗 器 械 法 规 证 书 课 程亚 洲 地 区 首靫 个 医 疗 器 械 法 规 资 质 证 书 课 程一 把 打 开 全 球 各 个 国 家韑 医 疗 器 械 市 场 的 金 钥 匙时 间 : 2009 年 9 月 16-17 日地 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 :符 合 法 规 的 要 求 对 于 医 疗 器 械 行 业 是 商 业 成 功 的 核頤 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 家韑 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 家韑 的 法 规 制 定 机 构 、 法 规 执 行 机 构 及 法 规 专 家韑 合 作 , 很 荣 幸 地 在 中 国设 立 了 首靫 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 家韑 法 规内 容韕 。 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 息韵 分 享 网 络 。BSI 还 将 和 您 分 享 大 量 的 实 践 案頥 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 , 香靬 港 , 台 湾 , 新 加 坡 , 马 来 西 亚 , 泰顃 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.comvivian.lim@bsigroup.com* 2 SZ FDA staff confirmed attendance of the above Certificate course on 16-17Sept

Others and Special Offers to Forum participants1. JMDR special offer to Regulatory Forum participantsJournal of Medical Device Regulation offers special pricing to forumparticipants. Please use the code “HK0808” code when making an orderDetails can be found at the later part of newsletter2. Special offer to Regulatory Forum participants from Medical DeviceManualThe Medical Devices Manual is a practical, comprehensive guide for all thoseworking with medical devices. Euromed Communication is offering a SpecialOffer £200 (original price £290) for Regulatory Forum participants. An orderform can be found at the later part of newsletter3. Clinivation WorldView special offer to Regulatory Forum participantsClinivation WorldView is the medical device and diagnostic industry's mostcomprehensive, authoritative, and up-to-date enterprise solution for On-Demand Global Regulatory Intelligence. Providing clear, step-by-step marketclearance regulations, processes, and guidance for >99% of the worldmarkets, only Clinivation WorldView delivers tried-and-true intelligence fromcertified, practicing professionals with real-world experienceBSI is also a subscriber of Clinivation WorldView and partner for Asiapromotion. Please contact Jack Wong (jack.wong@bsigroup.com) for specialForum pricing. Detail of the WorldView can be found at the later part ofnewsletter4. Hong Kong Medical Fair’s special offer to Regulatory ForumparticipantsAll new exhibitors can enjoy a 5% first-time exhibitor discount while overseasexhibitors (excl. Taiwan, mainland China and Macau) can enjoy 3-nightaccommodation (1 room) at a designated hotel.Details can be found at the later part of newsletter5. London Regulatory Conference’s special offer to Regulatory Forumparticipants10% discount will be offered to Forum participantsDetails 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 theMedical Device Regulatory trainingNameRicky HoSusan LeungWilliam KuDeborah KwongCarol ChenIvy KwokPetty FanGloria PoonMr. Cheney LuFlora LeeJo ChoiManson ChungCatherine ChengMaggie LeungChristine TsaiJames FanMandy YauCecilia ChanLeung, Man ChoFong, Yui KauMok, Siu Man ShirleyChan, Ka YanChan, Yat HeiLeung, Man ChoWinki IpAudrey ShumDr Francis KuaMr K K ChowFatima LaiOlivia ChanVissica WongMartha LeeLawrence YiuKayley WongSabrina ChanJenny WanMr CHIU Chi-Sang (LUCIANO BAPTISTA)K C LeeCarmen LaiPandora CheungMaggie HoJenny HoFrederic CampanaDoris ChengJanice WeiOrganizationAlconAsia Cardiovascular Products LtdAsia Cardiovascular Products LtdBDBDBDBDBaker & McKenzieBaker & McKenzieBayer HealthCare LtdBayer HealthCare LtdBayer HealthCare LtdBayer HealthCare LtdBoston ScientificBoston ScientificBoston ScientificBaxter Healthcare LtdBritish Consulate GeneralChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyClifford ChanceConstraint Management CenterConstraint Management CenterConsulate General of CanadaDentsplyDentsplyDKSHDKSHFerring PharmaceuticalsHKAPI (HK Association of Pharmaceutical Industry)HKAPI (HK Association of Pharmaceutical Industry)HKMRS (Hong Kong and Macau Regulatory Service) LtdHong Kong Standards and Testing Centre LimitedHospira LtdInvestHKJanssen PharmaceuticalJohnson & Johnson MedicalLNE ShanghaiMedtronicMedtronic

Emily ChiangJessie WongErica PoonSun QinMonita LauEdgar LeungIva NgCarin Ribbesjö-LundqvistFanny WongUlf LundqvistRonald LoAbdulielah. K . Al-MutairiKHALIL .H . AL GHAMDIAMJAD . S .ALGHAMDIFaisal . A . AlshehriZiad. F. AlsabelahALI . M .ALHAWASSultan . A . ALkanhalHUSSAM . M . ALAEQFahad . H . Al-MujalliAbdulrahman . A .Al-SwayedMajed .A . Al-QhtaniFelicia ChauGrace AuKamswee KooNatalie YanRonan ChanCat Hui Yuen TingEddie NganKaren LeeTammy WongMedtronicMedtronicMerck PharmaceuticalMolnlycke HealthcareOr & Lau, SolicitorsOrbit Medical Device Company LtdOrbusNeich Medical Co LtdQ-MedQ-MedQ-MedRoche Diagnostics (HK) LtdSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSaudi FDA, Saudi ArabiaSiemens Medcial Solutions Diagnostics LtdSSL HealthcareSSL HealthcareSSL HealthcareSt Jude MedicalSt Jude MedicalThe MacKay GroupWyeth(Freelance Marketing Expert)Next Medical Device Regulatory training in 2009 is as follow:2-3 Nov 09Contact Jack Wong (BSI) for detail of the training:jack.wong@bsigroup.com

Students completed thePharmaceutical Regulatory trainingNameVam ChengGeoffrey KokRose MakYolanda YanSusie ChanSusanna LeungYemmie TsangStanley YuSusanna YimMr Cheney LuStephanie PoonGloria PoonJingyan WeiCatherine ChengFlora LeeVivien LeeCecilia ChanWinki IpTimothy ChanLeung Man ChoFong Yui KauMok Siu ManChan Ka YanChan Yat HeiSidney NgKeith KeiAudrey ShumFatima LaiWinnie ChungDr Francis KuaMr K K ChowMichael LiDominic ChanHo Ping HimLawrence YiuLouisa IpKatherine LaiAgnes SinWendy ChengPang Chuen YeeWilson LunSabrina ChanJenny WanOrganizationAllerganAllerganAmerican Consulate GeneralAmgenAMO Asia LtdAsia Cardiovascular Products LtdAstraZenecaAstraZenecaBausch & Lomb (HK) LtdBaker & McKenzieBaker & McKenzieBaker & McKenzieBaker & McKenzieBayer HealthCare LtdBayer HealthCare LtdB Braun MedicalBritish Consulate GeneralChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyChinese University of HK, School of PharmacyCK Life Sciences Int'l., Inc.CK Life Sciences Int'l., Inc.Clifford ChanceConsulate General of CanadaConsulate General of CanadaConstraint Management CenterConstraint Management CenterCSL Biotherapies Asia Pacific LtdDaiichi Sankyo Hong Kong LimitedDaiichi Sankyo Hong Kong LimitedDKSHDorsey & WhitneyFerringFresenius Kabi Asia Pacific LtdGakderna Hong Kong LtdHing Wing Co LtdHing Wing Co LtdHKAPI (HK Association of Pharmaceutical Industry)HKAPI (HK Association of Pharmaceutical Industry)

Mr CHIU Chi-Sang (LUCIANO BAPTISTA)Pandora CheungMaggie HoFlorence LawJenny HoKanes HauJanet Lai Mei HoChris Kai Cheong ChowEdgar Shiu Lam LiuVincent Wong Ka-ChunMichael ChanDoris ChengComte ChanVincent TsuiEmily LeeErica PoonKane LeungDaniel CheungSuk ChanMonita LauSophie LiCorinna LiJenny LeungAnthy NgBritta SnackersTony KoMaria KongTess YeungSean MorleyRaymond LeePeggy YauJennifer LeeJesscia ChanTimothy ChanQuincy LeungRaccoon ChungMay YipDanny ChanDerek Chow Chun-PongAccacia KuKaren LeeVincci YipCalvin ChanTammy WongSung Kai-YiEddie Ngan Chiu-KwongHKMRS (Hong Kong and Macau Regulatory Service) LtdInvestHKJanssen PharmaceuticalJanssen PharmaceuticalJohnson & Johnson MedicalJohnson & Johnson MedicalLundbeck Hong KongLundbeck Hong KongLundbeck Hong KongManningsManningsMedtronicMentholatum Asia Pacific LtdMentholatum Asia Pacific LtdMerck Sharp & DohmeMerck PharmaceuticalNovo Nordisk Hong Kong LtdNovo Nordisk Hong Kong LtdNovo Nordisk Hong Kong LtdOr & Lau, SolicitorsOrbusNeich Medical (Shenzhen) Co., Ltd.Reckitt Benckiser Hong Kong Ltd.Reckitt Benckiser Hong Kong Ltd.Reckitt Benckiser Hong Kong Ltd.SandozServierServierServierStarcon CorporationStiefel Laboratories (HK) LtdSynovate HealthcareSynovate HealthcareTakedaTCM Healthcare (London) LtdUCB Pharma LtdWatsonsWatsonsWatsonsWatsonsWyethWyethWyethWyeth(Freelance Marketing Expert)(Personal)(Personal)Next Pharmaceutical Regulatory Training in 2009 is as follow:14 Oct, 11 Dec 20 09Contact Jack Wong (BSI) for detail of the training: jack.wong@bsigroup.com

** SPECIAL OFFER to HK Medical DeviceRegulatory Forum Participants **3 BOOKS FOR THE PRICE OF 2FAX TO: +44 (0) 1305 770836Choose any 3 publications from the list below and get theone with the lowest price for FREE1. 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 - £49.992. 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 numberis 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: £ (pound sterling) $ (US dollar) € (euro) I would like to pay on-line by credit card. Please send me a secure payment link to use.5. Order confirmationSignature: _____________________________________________Date: __________________________________All publications are supplied as a PDF by email and all orders are subject to Global Regulatory Press standard Terms & Conditions of Use.

21-22October2009,DanubiusHotelRegentsPark,London10% discount*forRegulatoryForum ParticipantsQUOTECQ7066BD1Oferavailableuntil18September2009*oftoppricetieronly

Prepare for your New LegalResponsibilitiesin HK and Asia?BSI, your regulatory partner inmedical device and pharmaceuticalsAround 2010, many Asian countries including Hong Kong, Malaysia, Singapore and India etc willhave implemented their brand new Medical Device RegulationsBSI (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 servicesThe link for you to understand the HK regulatory system and download Asia newsletters is:www.bsiamerica.com/HongKongRegForumFor more information, please contactJack WongVice President Regulatory Affairs, Asia; General Manager, Hong Kong, BSIEmail: jack.wong@bsigroup.com