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ASIA HONG KONG CONTACT US Global > Asia > Hong Kong HONG KONG Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information Hong Kong’s healthcare expenditure was 199.9 billion Hong Kong dollars during the fiscal year 2020/21, accounting for over seven percent of the region's gross domestic product (GDP). Over the last decade, Hong Kong's healthcare spending demonstrated substantial growth, escalating from 84.4 billion Hong Kong dollars in 2008/09 to nearly 200 billion Hong Kong dollars in the latest recorded period. ​ Market Trend: All Singaporeans have basic medical insurance in the form of MediShield Life. Another 69% have the Integrated Plan on top of the basic insurance. Hong Kong’s medical equipment market a nticipated revenue is projected to demonstrate an annual growth rate (CAGR 2024-2028) of 7.01%, leading to a market size of US$1,006.00 million by the year 2028. The inception of the Medical Device Division (MDD), formerly recognized as the Medical Device Control Office (MDCO), took place in July 2004. The MDD holds accountability for executing the Medical Device Administrative Control System (MDACS) and formulating a sustained statutory regulatory structure for medical devices. Market Info Medical Device Regulation Medical Device Division (MDD), under the DOH. https://www.mdd.gov.hk/en/home/index.html Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class I similar to Class I and A in EU and IMDRF respectively ​ Class II similar to Class IIa and B in EU and IMDRF respectively ​ Class III similar to Class IIb in EU and IMDRF respectively ​ Class IV similar to Class III or D in EU and IMDRF respectively Registration Useful Information Validity of License: 5 years. License transfer: A transfer application is required. ​ Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors. Infomation Need more details? We are here to assist. Contact us at A TTOPOLIS Platform. 需要更多详细信息？ ​ 我们在这里提供帮助。通过 ATTOPOLIS 平台联系我们。 Up

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services @ ARQ on Group ARQon Registration MedtechBOSS ATTOPOLIS B2B International Medical Device School ATTOMATCHING QuikQuality ARQ MTB ATP IMDS ARQon provides medical device product registration on various countries based on each country's regulations. Product Registration License Holding Extra RA/QA Support Drug Services Health Safety MedtechBOSS provides one-stop business strategy advisory to help MedTech company establish and grow their business presence globally. Global Market Strategy Technical Documentation Corporate Expansion Business Matching MedtechBOSS provides one-stop business strategy advisory to help MedTech company establish and grow their business presence globally. Global Market Strategy Documentation Corporate Expansion Business Matching Software Optimisation Tapping ISO / GDP ATTOPOLIS connects your business and showcase the variety of products and services globally B2B Marketplace Forum Events ATTOMATCHING Platform Platform to connect Startups and companies to following stakeholders- ​ Investor M&A Buyer Clinician Distributor CDMO/OEM Incubator/NGO Find out more! Attomatching International Medical Device School provide an overall comprehensive knowledge on Product lifecycle from design, manufacturing, regulatory and quality, and commercialization to MedTech professionals. Training QuikQuality Technical and Clinical compliance services, as well as Dashboard eQMS/eRMS for management of documents and registration status. - Regulatory compliance - Standard compliance Find out more! QuikQuality Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

Product Registration GMS Doc CE BM Vietnam Product Registration @ ARQon Business @ MedtechBOSS Global > ASEAN > Vietnam Global Market Strategy Technical Corporate Expansion Business Matching Global Market Strategy MARKET OBJECTIVES AND STRATEGIES MedtechBOSS navigate your market objectives to develop solid strategies for your market access and based on your product type in Vietnam. Contact Us for more details. GMS Doc Technical / Clinical / Quality Documentation QUALITY AND TECH ADVISORY MedtechBOSS provides Teachinical Files, MDF, ISO 13485, US QSR, GMP, GDP, MDSAP, CE MDR, MDD, IVD, IVDR Setup and Maintenance for Vietnam. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in Vietnam. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Vietnam. Contact Us for more details. Need more details? Cont act us We are here to assist. Contact us at AT TOPOL IS Platform. Up Cần thêm chi tiết? Liên hệ chúng tôi. Chúng tôi ở đây để hỗ trợ. Liên hệ với chúng tôi tại Nền tảng ATTOPOLIS.

Services @ ARQ on Group ARQon Registration MedtechBOSS ATTOPOLIS B2B International Medical Device School ATTOMATCHING QuikQuality ARQon Group Services ARQon provides health product registration on various countries based on each country's regulations. Product Registration License Holding Extra RA/QA Support Drug Services Health Safety MedtechBOSS provides one-stop business strategy advisory to help MedTech company establish and grow their business presence globally. Global Market Strategy Documentation Corporate Expansion Business Matching Software Optimisation Tapping ISO / GDP ATTOPOLIS connects your business and showcase the variety of products and services globally B2B Marketplace Forum Events International Medical Device School provide an overall comprehensive knowledge on Product lifecycle from design, manufacturing, regulatory and quality, and commercialization to MedTech professionals. Training ATTOMATCHING Platform Platform to connect Startups and companies to following stakeholders- ​ Investor M&A Buyer Clinician Distributor CDMO/OEM Incubator/NGO Find out more! QuikQuality Technical and Clinical compliance services, as well as Dashboard eQMS/eRMS for management of documents and registration status. - Regulatory compliance - Standard compliance Find out more! Gazette News Highlights Our events and highlights Forging Expertise, Nurturing Innovations View All Highlights Up Blogs Latest regulatory update Hong Kong: MDD Introduces a One-Stop e-Service, Medical... View All Blogs Up Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS Socials Medtech Insight, Citeline Commercial @Medtech_Insight EU Initiative Calls For Health App Assessments As Google And Apple ‘De Facto Regulators’... 00:00 PM 18 Jan 2023 • What Clients Say “ARQon has help AWAK achieve zero non-conformity during our ISO 13485: 2016 Quality Management Audit is not an easy feat to achieve. We like to thank them for their dedication and commitment in their work.”

Product Registration GMS Doc CE BM Taiwan Product Registration @ ARQon Business @ MedtechBOSS Global > Asia > Taiwan Global Market Strategy Technical Corporate Expansion Business Matching Global Market Strategy MARKET OBJECTIVES AND STRATEGIES MedtechBOSS navigate your market objectives to develop solid strategies for your market access and based on your product type in Taiwan. Contact Us for more details. GMS Doc Technical / Clinical / Quality Documentation QUALITY AND TECH ADVISORY MedtechBOSS provides Teachinical Files, MDF, ISO 13485, US QSR, GMP, GDP, MDSAP, CE MDR, MDD, IVD, IVDR Setup and Maintenance for Taiwan. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in Taiwan. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Taiwan. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. 需要更多详细信息？联系我们。 我们在这里提供帮助。通过 ATTOPOLIS 平台联系我们。 Up

Product Registration GMS Doc CE BM Saudi Arabia Product Registration @ ARQon Business @ MedtechBOSS Global > Middle East > Saudi Arabia Global Market Strategy Technical Corporate Expansion Business Matching Global Market Strategy MARKET OBJECTIVES AND STRATEGIES MedtechBOSS navigate your market objectives to develop solid strategies for your market access and based on your product type in Saudi Arabia. Contact Us for more details. GMS Doc Technical / Clinical / Quality Documentation QUALITY AND TECH ADVISORY MedtechBOSS provides Teachinical Files, MDF, ISO 13485, US QSR, GMP, GDP, MDSAP, CE MDR, MDD, IVD, IVDR Setup and Maintenance for Saudi Arabia. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in Saudi Arabia. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Saudi Arabia. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. هل تحتاج إلى مزيد من التفاصيل؟ اتصل بنا. Up

Global Pre sence Global Approval Continents All Countries AMERICAS ASEAN ASIA MIDDLE EAST EUROPE Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

Registration @ ARQ on We provide Regulatory Support for Local & Global Product Approvals and Compliance to local requirement on QMS with a Vision to assist companies to launch products faster in the market. ​ Medical Device Drugs Health Safety Sustainability License Holding CONTACT US Business Training B2B Global Marketplace & Forum License Holding We can hold your license for you. Product Registration Allow you to supply or trade your medical device in targeted countries. Extra RA/QA Support Comply with goverment regulation and higher quality products Global Approval It doesn't matter where you're from. ARQon Service Other services @ ARQon MedtechBOSS - Business One Stop Service - Medical Device File/Technical File/Documentation CE, US Quality Management System - ISO13485, USQSR, MDSAP, etc. Commercial matching business - destributor search, etc. VIEW MORE B2B International Medical Digital Platform that connects your business and showcase the variety of products and services globally VIEW MORE Product Lifecycle Training for Medtech Professionals Local & International Speakers Co founded by ARQon and ARPA VIEW MORE Gazette News HIGH LIGHTS Title Title Title BLOG S Title Title Title LIBRARIE S Title Title Title Check out our upcoming events below ARQ® -Class for Medical Device A tool to classify a medical device Complimentary for Client/Education/Authority Purchase ARQ-Class License Existing Member Log In Log In Classification for Medical Device Medical device are generally classified into 4 classes. ​ ASEAN MDD: Class A, B, C and D EU MDD: Class I, IIa, IIb and III Bulgaria Germany NZ source: Medsafe Japan X2 Malaysia X2 Singapore

Gazette New s News, insights and highlights Featured Highlights / Press Release Blogs Library Gazette Blogs Latest regulatory update 5 days ago Hong Kong: MDD Introduces a One-Stop e-Service, Medical Device Information System (MDIS) Medical Device Division (MDD) of Hong Kong introduced a new one-stop e-service platform for online application submissions for medical... 6 days ago Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024) On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing... May 2 South Korea: Philippines FDA Listed Ministry of Food and Drug Safety (MFDS) as Reference Drug Regulatory Authority On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory... Apr 23 Philippines: Regulatory Flexibility Extension for the Unlisted Class B, C, and D Medical Devices in the Registrable Medical Devices List The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26... Apr 16 Malaysia: Directive Overview of Natural Product Registration Based on 'Guideline on Natural Products with Modern Claim' (w.e.f 4 April 2024) The Drug Control Authorities (PBKD) agreed to register natural products based on the Guideline on Natural Products with Modern Claim,... Apr 9 Australia: Proposed Revision of Manufacturing Principles for Medicines, Active Pharmaceutical Ingredients, and Sunscreens (w.e.f 3 June 2024) Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles... Apr 8 Singapore: MOH ACE Implant Subsidy List (ISL) and HTA Process Updates The Ministry of Health (MOH) of Singapore implementing the Implant Subsidy List effectively from 1 December 2023. The list consists of... Apr 3 Hong Kong: MDACS Accepts Marketing Approval from Health Sciences Authority (HSA) of Singapore (w.e.f. 2 April 2024) The Health Sciences Authority (HSA) of Singapore was added to the Medical Device Division (MDD) acceptance list for marketing approval... Apr 2 India: PSUR Online Submission for Medical Devices/In-Vitro Devices Marketing Authorization (w.e.f 01 April 2024) The Circular, PSUR-13011(15)/1/2024-eoffice, was circulated by the Central Drugs Standard Control Organization (CDSCO) regarding the... Mar 27 Singapore: UDI Phase 2 Compliance Date Approaching (w.e.f 1 November 2024) The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the... Mar 26 Argentina: ANMAT Reviewing Changes to Sales Conditions for Medicinal Specialties (21 March 2024) Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution... Mar 20 Hong Kong: CP-05 for Listed Medical Devices Distributors by MDD (1 March 2024) On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device... 1 2 3 4 5 Highlights / Press Release Our past events and highlights Forging Expertise, Nurturing Innovations... View All Highlights Up Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS View All Events Up

Product Registration Product Registration Extra RA/QA Suppprt Drug Services Health Safety Spain Product Registration @ ARQon Business @ MedtechBOSS Global > Europe > Spain Product Registration Extra RA/QA Support Drug Services Health Safety Product Registration Contact Us for more details. Example Of Approval Not Avaliable - Product Registration Extra RA/QA Suppprt Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION Contact Us for more details. Drug Services Drug Services THERAPEUTIC AND COSMETIC APPROVAL Contact Us for more details. Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Necesitas más detalles? Contáctenos. Estamos aquí para ayudar. Contáctenos en la Plataforma ATTOPOLIS. Up

ASIA S OUTH KOREA CONTACT US Global > Asia > South Korea SOUTH KOREA Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information South Korea’s healthcare expenditure is $4570 per capita on health, similar to the OECD average of $4986 (USD PPP). This is equal to 9.7% of GDP, compared to 9.2% on average in the OECD. ​ Market Trend: All Singaporeans have basic medical insurance in the form of MediShield Life. Another 69% have the Integrated Plan on top of the basic insurance. South Korea’s medical equipment market is expected to reach US$7.09bn in 2024. ​ Korea Food and Drug Safety, along with its six regional offices, was founded in April 1996 and later elevated to administration status as the Korea Food & Drug Administration in 1998. In 2004, the organization underwent restructuring, leading to the establishment of the Medical Devices Management Division and Bioproduct Technical Support Division. In March 2013, it underwent another restructuring, achieving ministry status and undergoing a name change. Market Info Medical Device Regulation The Korean Ministry of Food and Drug Safety (MFDS), under the MOH. https://www.mfds.go.kr/eng/index.do Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class I Registration ​ Class II Certification ​ Class III and Class IV Approval from MFDS Registration Useful Information Validity of License: No expiry, KGMP certificate has to be renewed every three years. License transfer: The former license holder is required to transfer all rights and responsibilities to the new license holder. Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors. Information Need more details? We are here to assist. Contact us at A TTOPOLIS Platform. 자세한 내용이 필요하십니까? ​ 저희가 도와드리겠습니다. ATTOPOLIS 플랫폼으로 연락주세요. Up

Product Registration Product Registration License Holding Extra RA/QA Suppprt Drug Services Health Safety Israel Product Registration @ ARQon Business @ MedtechBOSS Global > Asia > Israel Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Product Registration Contact Us for more details . Example Of Approval Not Avaliable - Library Medical device regulatory guidelines View All Library Up Product Registration License Holding Extra RA/QA Suppprt License Holding ASEAN / Asia REP Contact Us for more details . Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION Contact Us for more details . Drug Services Drug Services THERAPEUTIC AND COSMETIC APPROVAL Contact Us for more details . Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ Contact Us for more details . Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. צריך פרטים נוספים? צור קשר. אנחנו כאן כדי לסייע. צור איתנו קשר בפלטפורמת ATTOPOLIS. Up