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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.

Europe EU Fra nce Germany Italy Spain Switzerland Europe Medical Device Registration ​ Most manufacturers would consider Europe as a first target region to penetrate, because of a single approval CE mark certificate(s) which allows penetration to different countries under the European Union. Penetration to other countries in Europe that are not under the European Union may not be difficult since there may be some collaboration agreement between the European Union and those countries. However, do note that for some European Union countries, the Competent Authorities would require product notification and promotion approval in their countries. Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

ASIA AU STRALIA CONTACT US Global > Asia > Australia AUSTRALIA 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 Australia’s healthcare expenditure is estimated at $105.8 billion in 2022-2023, representing 16.8% of the Australian Government’s total expenditure. ​ Market Trend: Forty five percent of Australians, or 11.8 million people, had private health insurance coverage for hospital treatment as of December 2022. Australia’s medical equipment market r evenue is expected to show an annual growth rate (CAGR 2023-2028) of 6.50%, resulting in a market volume of US$10.15bn by 2028. The Therapeutic Goods Administration is the medicine and therapeutic regulatory agency of the Australian Government founded in 1989. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Market Info Medical Device Regulation Therapeutic Goods Administration (TGA), under the Department of Health and Aged Care. https://www.tga.gov.au/ ​ Therapeutic Goods (Medical Devices) Regulations 2002 Regulation Classification, Fees, Timeline C,F,T Product Registration Routes ​ Class I Measuring or Sterile ​ Class IIa ​ Class IIb ​ Class III ​ ​ A IMD ​ Active Implantable Medical Devices Registration Useful Information Validity of License: 5 years. License transfer: The existing license holder has to submit transfer form and manufacturers evidence to TGA and pay $360 per application. 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 ATTOPOLIS. Up

EUROPE FRANCE CONTACT US FRANCE Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > Europe > France MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information France’s healthcare expenditure has increased significantly over the years, with spendings of approximately $6630 per capita on health in 2023, more than the OECD (Organisation for Economic Co-operation and Development) average of $4986 (USD PPP). This is equal to 12.1% of GDP, compared to 9.2% on average in the OECD. ​ Market Trend: The French government operates a universal health insurance (SHI) program for all of its citizens. Nearly 95% of people have Voluntary Health Insurance (VHI) , with 10.5% receiving means-tested subsidies and 8% receiving full subsidies for those with lower incomes. France’s medical equipment market is expected to have a revenue of approximately 20.58 billion USD by 2028 . Market Info Medical Device Regulation National Agency for the Safety of Medicines and Health Products, under the French National Authority for Health. https://gnius.esante.gouv.fr/en ​ Regulation of medical devices to be done with local listing and communicated to France ANSM Registration. Classification, Fees, Timeline Regulation Classification Product Registration Routes Class I ​ Class IIa, IIb, III, AIMDs ​ All Medical Devices need to bear the CE marking in order to be marketed in France. Regstration Routes 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. Besoin de plus de détails ? Nous sommes là pour vous aider. Contactez-nous sur la plateforme ATTOPOLIS. Up

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

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services Services @ Medtech BOSS QMS & Technical Documentation Global Market Strategy Business Matching Corporate Expansion Software & Tech Customisation Tapping ISO / GDP 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 Americas, ASEAN, Asia, Middle East and Europe. ​ ​ See more 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

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