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  • ARQon Singapore - Medical Device Consulting, Regulatory, Medtech, Medical Device Approval

    ARQon Regulatory & Medical Device Registration Services Our Mission To leverage our team's expertise in regulatory, commercial and connection to assist our clients in global market strategy, resolving issue, complying with the regulatory requirement and obtaining approval to meet the quality, safety and effectiveness for medical devices, therapeutic and drugs usage. We aim to contribute our comprehensive services to Healthcare industry and MedTech community globally.​​ 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 Philippines: Regulatory Flexibility Extension for the U... 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.”

  • Medical Device Consulting | Blogs | ARQon Gazette News

    Gazette New s News, insights and highlights Featured Highlights / Press Release Blogs Library Gazette Blogs Latest regulatory update 2 days ago 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... Mar 19 Taiwan: Essential Insights into Medical Mask Registration Requirements (15 March 2023) Following the amendment for the Medical Mask (CNS 14774 (T5017)) and Disposable Dust Respirators (CNS 14755 (Z2125)) under the... Mar 14 UK: New Guidance for Established Medicines Marketing Authorization Application Process Changes (w.e.f 1 March 2024) Effectively from 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released new process changes for the... Mar 6 Singapore: Final Phase for Transition of the ISO 13485 Certification Granted by SAC-Accredited Body for Medical Device Dealer License Applications (w.e.f 1 January 2025) Health Sciences Authority issued a reminder about the final transition year for all medical device dealers to obtain confirmation from... 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

  • Medical Device Consulting | Library | ARQon Gazette News

    Gazette New s News, insights and highlights April 2024 Highlights / Press Release Blogs Library Gazette Library Medical device regulatory guidelines Highlights / Press Release Our past events and highlights Forging Expertise, Nurturing Innovations... View All Highlights Up Blogs Latest regulatory update Philippines: Regulatory Flexibility Extension for the U... View All Blogs Up Events Our upcoming events are posted in ATTOPOLIS View All Events

  • Medical Device Consulting | Gazette News | ARQon

    Gazette New s News, insights and highlights April 2024 Highlights / Press Release Blogs Library Gazette Highlights / Press Release Our past events and highlights View All Highlights Up Forging Expertise, Nurturing Innovations... Bridging Diplomacy, Cultivating Collaborations... Established Strong Connections, Tightened the Community... Blogs Latest regulatory update View All Blogs Up Philippines: Regulatory Flexibility Extension for the U... Malaysia: Directive Overview of Natural Product Registr... Australia: Proposed Revision of Manufacturing Principle... Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS

  • Medical Device Consulting | Highlights/Press Release | ARQon Gazette News

    Gazette New s News, insights and highlights Featured Highlights / Press Release Blogs Library Gazette Highlights / Press Release Our events and highlights 4 Apr 2024 Forging Expertise, Nurturing Innovations... ARQon International Business Group is extending our warm gratitude to the Ministry of Health and Agency for Care Effectiveness (ACE) for inviting us t... 21 Mar 2024 Established Strong Connections, Tightened the Community... Thank you to the Singapore Business Federation (SBF) for successfully hosting their first orientation for SBF members. ARQon International Business G... 19 Mar 2024 IMDS 2024 (Day 2): Revealing Innovations in Medical Dev... International Medical Device School Day 2 was continued with the Design Thinking Workshop, sharing sessions on quality management systems, health safe... 2 Apr 2024 Bridging Diplomacy, Cultivating Collaborations... Greatest gratitude extended to the Dutch Chamber of Commerce for inviting ARQon International Business Group to their office for a fruitful discussion... 21 Mar 2024 IMDS 2024 (Day 4): Forging the Future with Research and... The final Day of the IMDS was hosted by Temasek Polytechnic offering a chance for participants to get a tour around Temasek Polytechnic and visit the ... 18 Mar 2024 IMDS 2024 (Day 1): Exploring the Intersection of Medica... The IMDS - International Medical Device School once again raised its curtain for 4 days from 18 March 2024 to 21 March 2024. IMDS is a well-known annu... 26 Mar 2024 Connecting Healthcare Leaders, Fostering Connections... The networking session hosted by the French Chamber of Commerce in Singapore (FCCS) CS for its healthcare industry members in Singapore created a live... 20 Mar 2024 IMDS 2024 (Day 3): Navigating Market Dynamics and Maste... The highlight of IMDS Day 3 was Market & Supply Chain Strategy, equipped with experienced speakers from various backgrounds and industries. This day's... 17 Mar 2024 International Hub Showcasing Advanced Medical Technolog... ARQon CEO May Ng ARQon l Asia Regulatory and Quality Consultancy, took an opportunity to visit KIMES 2024 while on a business trip to Korea. It was a ... 1 2 3 4 5 1 ... 1 2 3 4 5 6 7 8 9 10 11 12 13 14 ... 14 Blogs Latest regulatory update Philippines: Regulatory Flexibility Extension for the U... View All Blogs Up Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS View All Events Up

  • Medical Device Consulting | Company | ARQon

    About U s Our Team Our Clients Testimonials Company Company ARQon is a regulatory consultancy for medical devices and drug companies. We assist our clients in aspects of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World. Our range of clients includes researchers, manufacturers and traders from both start-ups and MNCs. Additionally, ARQon provides training sessions for researchers, manufacturers and regulators. Vision To be world-class regulatory service provider and to contribute to healthcare. Mission To leverage our team's expertise in regulatory, commercial and connection to assist our clients in global market strategy, resolving issue, complying with the regulatory requirement and obtaining approval to meet the quality, safety and effectiveness for medical device, therapeutic and drugs usage. We aim to contribute our comprehensive services to Healthcare industry and MedTech community globally.​​ Team We are formed from individuals with vast experiences in medical device and drug manufacturing sites, trading industry and in regulatory authority. ​ With regulatory authorities background, we balance the nation's requirement for patients safety with the need to foster and advance medical options in an environment to limited resources, We have experience in the manufacturing environment from start-ups to MNCs, from greenfield sites to mergers and acquisitons. We understand manufacturing targets, needs and limitations, We have experience obtaining global registration from CE, US, Asia, ASEAN, and rest of the world (ROW). As a key partner to the sales and marketing function, we can pave the way to generate revenue and meet business targets, We together share the same mission, we contribute to healthcare. Company Global Regulatory & Quality Director, ARQon group CEO ​ ​ Bsc (Biochem & Microbio) MSc (BioMedical Eng) Grad Dipl (Medtech Manufacturing) May Read more Medical Device: Combination, Implants, IVDs Global Product Registration, QMS, Audit ex: HSA, Biosensors ASEAN-China & Singapore agencies advisors and committee, International speaker Origin: Singapore, Malaysia, ASEAN ARQon Team Biologics & Drugs ​ PhD in Mic robiology Stephen Read more Regulatory & Quality Consultant ​ Bsc Mechanical Engineering Ray Read more Biologics & Drugs GMP, GLP, GDP, GDPMD ex: HSA, GSK, Teva Origin: US, Taiwan ROC, Singapore Global Product Registration, ISO13485, FDA, QMS ex: Oculus (MR), Illumina Origin: Singapore Regulatory & Quality Consultant ​ Diploma in Biomedical Engineering Trish Global Product Registration Origin: Singapore, Philippines Regulatory & Quality Consultant ​ Diploma in Biomedical Engineering Beatrice Global Product Registration Origin: Singapore Regulatory ​ ​ ARQon Malaysia Azmina Read more Regulatory Affairs Origin: Malaysia Our Team Our Clients Testimonials Regulatory & Quality Associate Diploma in Materials Science Kah Suan Read more Regulatory Affairs Origin: Singapore ​Senior Corporate Administrator ​ ARQon Singapore Bing Kang HR Affairs Origin: Singapore Inquiries for Staff Our Clients What Our 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.” “ARQon has help to complete the MDSAP gap analysis in a timely and professional manner and as a result we have reached a new milestone in achieving MDSAP certification effortlessly for MediPurpose.” Services @ ARQ on Group Check out our services ARQon MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global Market Strategy Technical Documentations Corporate Expansion Business Matching Business Hub ATTOPOLIS IMDS B2B Marketplace Forum Events Training Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

  • Medical Device Consulting | Contact | ARQon

    CONTACT LOCATIONS HEADQUARTERS ARQon Pte. Ltd. 221 Henderson Road #02-08, Henderson Building, Singapore 159557 Main Tel: +65 69808213 Mobile/Whatsapp: +65 98801432 Email: info@arqon.com / support@attopolis.com ​ MedtechBOSS Pte. Ltd. 2985 Jalan Bukit Merah #01-1C Singapore Manufacturing Federation Building, Education Wing Singapore 159457 ​ ASEAN ARQon Medtech Sdn. Bhd. No. 42-02, Jalan Adda 7, Taman Adda Heights, 81100 Johor Bahru, Johor, Malaysia ​ ARQon Vietnam Co ., Ltd. No. 23, Group 10, Linh Nam Street, Linh Nam Ward, Hoang Mai District, Hanoi, Vietnam ​ PT ARQon INDONESIA PRIMA Central Park Cikarang, Blok A2 No. 15, Kel. Karangraharja, Kec. Cikarang Utara, Kab. Bekasi, Prov. Jawa Barat 17530, Indonesia ​ PT ARQon Solusi Medika Rukan Niaga Gunung Sahari Blok B-2, JI Gunung Sahari Raya No 7, Jakpus 10720, Indonesia ​ ARQon Medical Technology Phils Inc G/F MHI Bldg, No 2A New York St. IV Immaculate Concepcion, Quezon City, Metro Manila, Phillippines ​ ARQON MEDTECH (THAILAND) Co., Ltd 15 Soi Tiwanon 27 Yak 4/1 BangKraSor, MuengNonthaburi Nonthaburi 11000, Thailand ​ ASIA ARQon Medtech Co. Ltd 2F, No. 421, Shengli Rd. North Dist., Tainan City 70456, Taiwan ROC ​ ARQon Medtech (Greater China) Ltd Room A, 16/F, Amtel Building, 144-148 Des Voeux Road, Central, Hong Kong ​ CTNS ARQon 1206, Partners Tower 2,16, Digital-ro 32-gil, Guro-gu, Seoul, Korea ​ ARQon Medtech (Greater India) Pte. Ltd TC 5/42, Kara G 13, Tech Valley, Cheruvaikkal, Sreekaryam, Thiruvananthapuram, Thiruvananthapuram-695017, Kerala, India ​ EUROPE ARQon Medtech Europe GmbH Thurgauerstrasse 117, 8152 Glattpark (Opfikon), Switzerland ​ AMERICA 880 East Fremont Ave. #431 Sunnyvale, California 94087, United States ​ OCEANIA 109 Ridgemont Drive, Berwick Victoria, Australia 3806 ​ 13 Fernbank Lane Greenhithe, Auckland, New Zealand, 0632 ​ ​ GLOBAL ​ HOSPITAL & PHARMACY ​ Jen-Ai Hospital No. 10, Sec. 1, Beimen Rd, East Dist, Tainan City 70145, Taiwan ​ First United Medical Clinic 1F, No. 421, Shengli Rd, North Dis t, Tainan City 70456, Taiwan For enquiry at ATTOPOLIS by ARQon Enquire Here ARQon Headquarters Office Location Our ARQon office is located at Henderson Building. To head to ARQon Headquarters, please head up to level 2 and walk straight. Our office will be on your left. Our MedTechBOSS office is located at SMF, please turn right from the lobby at level 1 and walk straight. ARQon Office Car Park Car Park @ SMF SMF car park sometimes with limited parking space. If SMF car park is full, please park at the alternative car park Car Park (Alternative 1) Maple Tree Industrial Estate Car Park – Can be accessed via Lower Delta Road, turn left after Cendex Centre. Car Park (Alternative 2) Bukit Merah View, HDB Blk 121 Car Park – Directly opposite SMF House, beside HDB Blk 121. Car Park @ Henderson Building Vehicles without the Henderson Building label, please park at level 1 only. Suggested Route By Public Transport: Alight at Tiong Bahru MRT Board Bus 5 Alight at 2nd Bus Stop

  • Medical Device Consulting|Registration|Spain|AEMPS|Regulation|ARQon

    EUROPE SPAIN CONTACT US SPAIN Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > Europe > Spain MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information Spain's healthcare expenditure has been linearly increasing with the most recent recorded value of 2,926 USD per capita in 2021. ​ Market Trend: In Spain, the healthcare is funded by from a combination of taxes and social security contributions, with the autonomous regions being accountable for managing and allocating healthcare funds provided by the central government. Spain’s medical equipment market is estimated to reach 10.90 billion USD by 2028. Market Info Medical Device Regulation Spanish Agency of Medicines and Medical Products (AEMPS). https://www.aemps.gob.es/productos-sanitarios/productos-sanitarios/?lang=en ​ Regulation Classification, Fees, Timeline Classification Product Registration Routes Class I Can be placed on market immediately with the CE marking ​ Class IIa, IIb, III, AIMDs Requires a submission of communication to the Regulatory Authority ​ All Medical Devices need to bear the CE marking in order to be marketed in Spain. Registration Useful Information Validity of License: 5 years License transfer: Change of Registration application needed. Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors. ​ Quality System: ISO 13485:2016 Useful Info Need more details? We are here to assist. Contact us at ATTOPOLIS Platform. Necesitas más detalles? Estamos aquí para ayudar. Contáctenos en la Plataforma ATTOPOLIS. Up

  • Medical Device Consulting|Registration|South Korea|MFDS|Regulation|ARQon

    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

  • Medical Device Consulting|Registration|Taiwan|TFDA|Regulation|ARQon

    ASIA TAIWAN CONTACT US Global > Asia > Taiwan TAIWAN 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 Taiwan’s healthcare expenditure was approximately 6.6% of its Gross Domestic Product (GDP) in January 2022. ​ Market Trend: In March 1995, the Taiwanese government implemented the national health insurance (NHI) system, which replaced various separate insurance schemes that covered approximately 57% of the population prior to its introduction. Taiwan’s medical equipment market stands as a significant market for U.S. medical device exports, being positioned within the top 25 globally in terms of value. By 2019, Taiwan's medical device market had expanded to around $4.2 billion, constituting about 5.4% of the entire healthcare expenditure in the country. The inception of the Taiwan Food and Drug Administration (TFDA) occurred on January 1, 2010, subsequent to the passing of the TFDA Organization Act on June 3, 2009. This act amalgamated several bureaus, including the Bureau of Food Safety, the Bureau of Pharmaceutical Affairs, the Bureau of Food and Drug Analysis, and the Bureau of Controlled Drugs into the TFDA. Following the enforcement of the Organic Act of the Ministry of Health and Welfare in July 2013, the Taiwan Food and Drug Administration (TFDA) became a component of the newly established Ministry of Health and Welfare. Market Info Medical Device Regulation Taiwan Food and Drug Administration (TFDA), under the MOHW. https://www.fda.gov.tw/eng/siteList.aspx?sid=10333 ​ Regulation of medical devices done under the Medical Devices Act . Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class I, II, III, IV ​ Standard Mode ​ Simplified Mode ​ Priority Review For Class II (NT$15,000) and III (NT$30,000) . Expedites reviews by 1-2 months. Registration Useful Information Validity of License: 5 years. (Renewal application must be submitted 10 months before the expiry date) License transfer: Submit a pplication form for change in medical device permit license. 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. 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

  • Medical Device Consulting|Registration|Japan|MHLW|Regulation|ARQon

    ASIA JAPAN CONTACT US Global > Asia > Japan JAPAN 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 Japan ’s healthcare expenditure amounted to approximately 43 trillion Japanese yen in the fiscal year 2020, an increase from around 38.6 trillion Japanese yen in fiscal 2011. ​ Market Trend: Japan's statutory health insurance system (SHIS) provides coverage for 98.3% of the population, with the remaining 1.7% covered by the distinct Public Social Assistance Program designed for impoverished individuals. The projected compound annual growth rate for Japan’s medical equipment market between 2022 and 2027 is estimated to be 4.1% in local currency terms and 6.9% in US dollar terms. After the Cabinet meeting approved the Reorganization and Rationalization Plan for Special Public Corporations in 2001, the Pharmaceuticals and Medical Devices Agency (PMDA) was created. This agency commenced operations on April 1, 2004, established under the Law for the Pharmaceuticals and Medical Devices Agency. It amalgamated the functions of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and a segment of the Japan Association for the Advancement of Medical Equipment (JAAME). Market Info Medical Device Regulation Pharmaceuticals and Medical Devices Agency (PMDA), under the MHLW. https://www.pmda.go.jp/english/index.html Regulation Classification, Fees, Timeline CFT Product Registration Routes Class I Notification to the PMDA. Class II Certification by registered certification body. Class II (Others) Approval of the MHLW. ​ Class III Certification by registered certification body. ​ Class III (Others) ​ Approval of the MHLW. ​ Class IV ​ Approval of the MHLW. Registration Useful Information Validity of License: 5 years. License transfer: Change of Registration application needed. Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors. Useful Info Need more details? We are here to assist. Contact us at A TTOPOLIS Platform. 詳細が必要ですか? ​ 私たちは支援するためにここにいます。 ATTOPOLIS プラットフォームまでお問い合わせください。 Up

  • Medical Device Consulting | Business | Middle East | ARQon MedtechBOSS

    Product Registration GMS Doc CE BM Emirates Product Registration @ ARQon Business @ MedtechBOSS Global > Middle East > Emirates 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 Emirates. 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 Emirates. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in Emirates. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Emirates. 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. نحن هنا للمساعدة. اتصل بنا على منصة ATTOPOLIS. Up

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