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Product Registration Product Registration Extra RA/QA Suppprt Drug Services Health Safety Bulgaria Product Registration @ ARQon Business @ MedtechBOSS Global > Europe > Bulgaria Product Registration Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN BULGARIA ​ According to Bulgaria’s legislation, the submission of documents for a medical device clinical trial approval shall be made to the Bulgarian Drug Agency (BDA). ​ MEDICAL DEVICE REGISTRATION AND APPROVAL IN BULGARIA ​ The following list of documents should be submitted to BDA: 1. Application form 2. Identification data for the medical device 3. Clinical trial design 4. Schedule of the clinical study 5. Declaration that the medical device complies with all relevant essential requirements excluding those which are object of clinical trial, and that all expected safety measures have been taken to ensure the safety and health of the subjects in the trial and of the investigating team; 6. Agreement template between the sponsor and the site; Example Of Approval Not Avaliable - Product Registration Extra RA/QA Suppprt Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION ARQon provide onsite/offsite monthly regulatory support for regional registration in Bulgaria. Contact Us for more details. Drug Services Drug Services THERAPEUTIC AND COSMETIC APPROVAL ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Bulgaria. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Bulgaria. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Нуждаете се от повече подробности? Свържете се с нас. Ние сме тук, за да помогнем. Свържете се с нас в платформата ATTOPOLIS. Up

Singapore Product Registration @ ARQon Business @ MedtechBOSS Global > ASEAN > Singapore Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN SINGAPORE Singapore is one of the ASEAN countries where the product registration must be done by a local registrant. Although the country is small, many medical devices are made available due to the needs of consumers and healthcare professionals. The Health Sciences Authority (HSA) was formed since 2001 when the voluntary registration was introduced. There were over 4000 medical devices that were approved back then. Health Products (Medical Devices) Regulation was implemented in August 2011 and all medical devices have to be approved by the Medical Device Branch of HSA before it can be supplied in Singapore. There are benchmarking route of applications available in Singapore as Singapore’s regulatory framework is based on IMDRF (formerly known as GHTF). ​ Medical devices including IVD is classified into 4 classes, namely the low-risk Class A, low-medium risk Class B, high-medium Class C and the highest risk Class D. For IVD in Singapore, the control is slightly different from European Union (EU). Regardless of its risk classification, all medical devices (unless exempted from product registration) for importation and supply (in Singapore or re-export) must meet one of the following criteria: · Listed on the Singapore Medical Device Register (SMDR); · Listed on the Transition List; or · Authorised via one of the Authorisation Routes. MEDICAL DEVICE REGISTRATION AND APPROVAL IN SINGAPORE Class A sterile, Class B, Class C and Class D medical devices must be submitted to HSA before it can be supplied in Singapore. Grouping is allowed in Singapore and is named Single, Family, System, Test kit or Group. Product registration dossier must be prepared in accordance with the ASEAN Common Submission Dossier Template (CSDT). During the product registration application, ARQon will work with manufacturers on the device classification, grouping and CSDT preparation. ​ In Singapore, applications must be submitted online via Medical Device Information and Communication Systems (MEDICS). Prior to submission, the company has to apply for a CRIS (Client Registration and Identification Service) account and registered as a CRIS Administrator to gain access to MEDICS. ​ The company must be a local entity company, otherwise, ARQon can submit the application with authorization from the Product Owner. The local entity is known as a Local Authorised Representative. The appointed Importer and Wholesaler must have a Dealer License with Good Distribution Practice for Medical Device in Singapore (GDPMDS)/SS620 or ISO 13485 compliance. GDPMDS/SS620 certification should be obtained from a recognized certification body that is accredited by the Singapore Accreditation Council. ​ Class A non-sterile medical device requires a simple notification and Dealer’s License is still applicable to the local company entity. There are different abridged evaluation routes available in Singapore where it can be 0 approval time. If the medical device has been evaluated and obtained market clearance in at least one of the GHTF founder member countries, abridged evaluation route is applicable. Otherwise, the full evaluation route of application applies. ​ The Turn Around Time (TAT) for the Product registration will vary depending on the device class and type of evaluation. ​ Library Medical device regulatory guidelines View All Library Up product License Holding ASEAN / Asia REP Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance. Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative. ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally. Whether you are a local or foreign manufacturer, ARQon can assist to: Be your local representative in the country. Submit product registrations for all product classifications. Set up the QMS & technical file for ISO13485, GDP and CE Hold product license in the country. Transfer product license to distributor (when manufacturer secure its preferred distributor in the country) Appoint multiple importers and distributors. Read more Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION ARQon provide onsite/offsite monthly regulatory support for regional registration in Singapore. ​ Contact Us for more details. LH extra Drug Services THERAPEUTIC AND COSMETIC APPROVAL ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Singapore. ​ Read more drug Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Singapore. ​ Contact Us for more details. health Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services @ Medtech BOSS QMS & Technical Documentation Global Market Strategy Business Matching Corporate Expansion Software & Tech Customisation Tapping ISO / GDP Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Advisory with partners on Company Incorporation, Legal, Tax in Americas, ASEAN, Asia, Middle East and Europe. All businesses set-up by MedtechBOSS include: FREE 3 months workstation and WIFI connection at our strategic hub FREE 3 months Company registered office & correspondence address FREE 1 month Admin support eg day to day operation in office, liaison for talent search Corporate Secretarial Support Corporate Accounting Support Strategic Business Services Business Valuation Business Review Assessment Mergers, Acquisitions & Restructuring Strategic Business Planning Due Diligence Profitability Management Financial Planning and Management Working Capital Management and Cashflow CFO Support Services Re-domicile of Overseas Investments Funds Variable Capital Company (VCC Structure) Set-up Investment, Market Research, Strategy Advisory Accounting Solutions Reconstruction of Accounts Head-office Reporting Group Consolidation/ Combined Financial Statements Accounting and Fixed Assets Schedules P&L and Cash Flow Budget Payroll Support Periodic Bookkeeping include maintenance of Ledgers & Sub-ledgers Bank Reconciliation Compilation of Annual Financial Statements Finance Training XBRL Conversion Business Set-Up & Tax Services Company Incorporation & Business Registration Corporate Secretarial Services Nominee Director Services Company Cessation and Business Liquidation Services Know Your Client ("KYC") Services Local Registered Office and Correspondence Address Corporate Tax & Compliance Individual Tax GST & VAT Registration and Filing Tax Planning and Advisory Risk Management & Assurance Detection of Potential Accounting Errors/Mismanagement/Fraud Internal Audit Statutory Audit (Liaison Role) Business Risks Insurance Analysis Office Solutions One-stop Smart Office (IT) Solutions, Cybersecurity & Data Privacy Marketing Solutions & Business Website Printing Services (Name Cards & Brochures) Not what you're looking for? Check out other services ARQon Product Registration License Holding Extra RA/QA Support Drug Services Health Safety MedtechBOSS Global Market Strategy Technical Documentation Corporate Expansion Business Matching Software Customisation Tapping ISO/GDP Business Hub ATTOPOLIS B2B Marketplace Forum Events IMDS Training Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

Gazette New s News, insights and highlights Featured Highlights / Press Release Blogs Library Gazette Atto Updates Thank you for your continued support, and we look forwa... ARQon Gazette Thank you for your continued support, and we look forward to bringing you more great content for ARQon Gazette. Thank you for your continued support, and we look forward to bringing you more great content for ARQon Gazette. Thank you for your continued support, and we look forward to bringing you more great content for ARQon Gazette.

Product Registration GMS Doc CE BM New Zealand Product Registration @ ARQon Business @ MedtechBOSS Global > Asia > New Zealand 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 New Zealand. 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 New Zealand. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in New Zealand. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in New Zealand. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Up

ASEAN THAILAND CONTACT US THAILAND Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > ASEAN > Thailand MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information Thailand’s healthcare expenditure was approximately 462.3 billion Thai baht in 2020. ​ Market Trend: In 2021, the majority of health insured people had universal coverage cards, accounting for around 74.5 percent of all insured people. In that same year, the total number of people who are covered by health insurance in Thailand amounted to around 67.7 millio n. Thailand’s medical equipment market was estimated to be worth about 6.9 billion U.S. dollars in 2023. Projections indicated that by 2030, this figure is expected to rise to approximately 11.4 billion U.S. dollars. In the realm of medical devices, Thailand's registration process is overseen by the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA). Established in 1991, the MDCD holds the responsibility for upholding compliance with these specific regulations pertaining to medical devices. It is also empowered to take appropriate measures against any entity or individual found in violation of these regulations. Market Info Medical Device Regulation Medical Device Control Division (MDCD), under the FDA. https://medical.fda.moph.go.th/ Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class 1 & Animal Medical Devices Certificate of Listed Medical Devices Class 2 & 3 Certificate of Notified Medical Devices Class 4 Certificate of Licensed Medical Devices ​ ​ Full Evaluation ​ Concise Pathway (For Class 2-4) Recognizes reference agencies' approval. ​ Reliance Program (For Class 2-4 or B, C, D Medical Devices) Relies on the approval from Health Science Authority (HSA), Singapore. Registration Useful Information Validity of License: 5 years. License transfer: No transferring of license is provided by the Thai regulations. Importer and Distributor: Local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA's manual of medical device classification. Information Need more deta ils? We are here to assist. Contact us at A TTOPOLIS Platform. ต้องการรายละเอียดเพิ่มเติม ? เราอยู่ที่นี่ เพื่อช่วยเหลือ ติดต่อเราได้ที่แพลตฟอร์ม ATTOPOLIS. Up

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

Product Registration GMS Doc CE BM Switzerland Product Registration @ ARQon Business @ MedtechBOSS Global > Europe > Switzerland Global Market Strategy Technical Corporate Expansion Business Matching Global Market Strategy MARKET OBJECTIVES AND STRATEGIES MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Switzerland. 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 Switzerland. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in Switzerland. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Switzerland. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Benötigen Sie weitere Informationen? Kontaktiere uns. Wir sind hier, um zu helfen. Kontaktieren Sie uns auf der ATTOPOLIS-Plattform. Up

Product Registration Product Registration License Holding Extra RA/QA Suppprt Drug Services Health Safety Colombia Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > Americas > Colombia Medical Device Product Registration and Approval MEDICAL DEVICE REGISTRATION AND APPROVAL IN COLOMBIA ​ Medical device classification in Colombia follows the four-tiered risk model, much like the one used in Europe (Class I, Class lla, Class llb and Class lll). Interventional Concepts must verify the classification of the medical device before registration. To register, the following will guide you on the required procedures: ​ Assign a home country representative under the absence of a local presence in Columbia; Get an in-country Certification of Free Sale (CFS) or Certificate to Foreign Government or any INVIMA approved market; Present quality system certificate (i.e. ISO 13485); Present information and commercial history of the product - Test reports on Classes lla, llb and lll devices are necessary and clinical data is required for Classes llb and lll devices; The legal representative will submit the application in Spanish to INVIMA and will pay the required fee. The approval process could take up to 3-4 months; and A registration certificate will be issued upon approval, and will be valid for 10 years. Example Of Approval DOWNLOAD Source: INVIMA Library Medical device regulatory guidelines View All Library Up Product Registration License Holding Extra RA/QA Suppprt License Holding LATIN AMERICA REP Foreign manufacturers must appoint an US agent as a local point of contact with US FDA. If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US. ​ Some of the responsibilities include: Acting as a first point of contact with Regulatory authorities and import/customs offices Being responsible for pre-certification and post-approval inquiries Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION ARQon provide onsite/offsite monthly regulatory support for regional registration in Colombia. Contact Us for more details. Drug Services Drug Services THERAPEUTIC AND COSMETIC APPROVAL ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Colombia. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Colombia. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Necesito más detalles? Contacta con nosotras Estamos aquí para ayudar. Contáctenos en la Plataforma ATTOPOLIS. Up

Product Registration GMS Doc CE BM Singapore Product Registration @ ARQon Business @ MedtechBOSS Global > ASEAN > Singapore 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 Singapore. 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 Singapore. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in Singapore. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in Singapore. Contact Us for more details. Need more details? Cont act us We are here to assist. Contact us at AT TOPOL IS Platform. Up

Product Registration Product Registration License Holding Extra RA/QA Suppprt Drug Services Health Safety Canada Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > Americas > Canada Medical Device Product Registration and Approval MEDICAL DEVICE REGISTRATION AND APPROVAL IN CANADA Medical devices are classified into 4 categories namely class I, II, III and IV (I being the lowest risk and IV being the highest risk). ​ •Class I device does not require a registration license; and •Classs II, III, IV, the product registration requirements are as per written in the Canadian Medical Device Regulation (CMDR). The CMDR is also mentioned in specific the Quality Management System (QMS) requirements for the manufacturer. Currently, the manufacturer is required to comply with the quality management system known as CAN/CSA ISO13485 from the recognized registrar under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). This quality system will be replaced by MDSAP quality management system requirements by 1 Jan 2019. ARQon can assist with product registration in Canada and setting-up of the quality management system so as to meet CAN/CSA ISO13485 or the MDSAP. In terms of the Establishment License for the company, there are requirements for the Manufacturer, Importer and Distributor. This Establishment concept has also been referenced to the development of Establishment Licensing requirements in Asia including Singapore. ARQon director has also helped in drafting of the Singapore regulation. ​ MEDICAL DEVICE REGISTRATION AND APPROVAL IN CANADA Medical devices are classified into 4 categories namely class I, II, III and IV (I being the lowest risk and IV being the highest risk). ​ •Class I device does not require a registration license; and •Classs II, III, IV, the product registration requirements are as per written in the Canadian Medical Device Regulation (CMDR). The CMDR is also mentioned in specific the Quality Management System (QMS) requirements for the manufacturer. Currently, the manufacturer is required to comply with the quality management system known as CAN/CSA ISO13485 from the recognized registrar under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). This quality system will be replaced by MDSAP quality management system requirements by 1 Jan 2019. ARQon can assist with product registration in Canada and setting-up of the quality management system so as to meet CAN/CSA ISO13485 or the MDSAP. In terms of the Establishment License for the company, there are requirements for the Manufacturer, Importer and Distributor. This Establishment concept has also been referenced to the development of Establishment Licensing requirements in Asia including Singapore. ARQon director has also helped in drafting of the Singapore regulation. Example Of Approval DOWNLOAD Source: Health Canada Library Medical device regulatory guidelines View All Library Up Product Registration License Holding Extra RA/QA Suppprt License Holding LATIN AMERICA REP Foreign manufacturers must appoint an US agent as a local point of contact with US FDA. If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US. ​ Some of the responsibilities include: Acting as a first point of contact with Regulatory authorities and import/customs offices Being responsible for pre-certification and post-approval inquiries Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION ARQon provide onsite/offsite monthly regulatory support for regional registration in Canada. Contact Us for more details. Drug Services Drug Services THERAPEUTIC AND COSMETIC APPROVAL ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Canada. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Canada. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Up