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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

ASEAN PHILIPPINES CONTACT US PHILIPPINES Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > ASEAN > Philippines MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information Philippines healthcare expenditure was forecast to continuously increase between 2024 and 2028 by in total 9.6 billion U.S. dollars. Market Trend: The Philippines healthcare insurance market is projected to grow from $4.46 Bn in 2022 to $8.31 Bn by 2030, registering a CAGR of 8.1% during the forecast p eriod of 2022-2030. Philippines medical equipment market 's revenue is expected to show an annual growth rate (CAGR 2023-2028) of 10.78%, resulting in a market volume of US$1,218.00m by 2028. ​ The Center for Device Regulation, Radiation Health, and Research (CDRRHR) operates as the national body within the Department of Health's Food and Drug Administration, overseeing the control of manufacturing, importation, exportation, distribution, sales, advertising, and utilization of electrical or electronic devices with radiation-emitting capabilities. Market Info Medical Device Regulation Center for Device Regulation, Radiation Health, and Research (CDRRHR), under the FDA. https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health ​ Regulation Classification, Fees, Timeline C,F,T Registration Product Registration Routes Class A (CMDN) Notification Class B, C, D (CMD R) Registration ​ IVD (CPR) Registration Useful Information Validity of License: 5 years. License transfer: Transfer application requires the original registration certificate. 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. Kailangan ng higit pang mga detalye? Nandito kami para tumulong. Makipag-ugnayan sa amin sa ATTOPOLIS Platform. Up

AMERICAS MEXICO CONTACT US Global > Americas > Mexico MEXICO 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 Mexico’s healthcare expenditure per person decreased to approximately 1,181 U.S. dollars in 2022, compared to the 1,262 U.S. dollars spent per capita on health in the previous year. ​ Market Trend: Approximately 59.9% of the population lacks medical insurance. The primary insurance institution is the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social, IMSS), providing coverage for 29.5% of the population. Private insurance agencies extend coverage to 1.5% of the total population. Mexico’s medical equipment market is expected to show an annual growth rate (CAGR 2024-2028) of 4.70%, resulting in a market volume of US$9.72bn by 2028. ​ The Secretariat of Health in Mexico (Secretaría de Salud), oversees the formulation of national health policy and various aspects of health services. This includes the regulation of drugs and medical devices. The regulatory framework governing the import and export of medical products and food is defined by the General Health Law, known as "Ley General de Salud" in Spanish. Market Info Medical Device Regulation The Mexican Secretariat of Health (COFEPRIS) https://www.gob.mx/salud/en Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class I, II, III ​ Expedited Route (Third Party Route-TPR) ​ Equivalency Route (Applicable for all medical devices approved in the US, Canada, and Japan) Registration Useful Information Validity of License: 5 years. License transfer: In Mexico, the transfer of local registration holders is permissible, contingent upon the original holder's agreement. To formalize this transfer, both parties must sign a contract transferring the rights, a process that requires notarization. The agreement explicitly outlines the relinquishment of registration by the original holder. Additionally, a copy of the Registration Certificate, including any modifications made post-approval, must accompany the transfer documentation. 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 ATTOPOLIS Platform. Necesito más detalles? Estamos aquí para ayudar. Contáctenos en la Plataforma ATTOPOLIS. Up

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

AMERICAS CANADA CONTACT US Global > Americas > Canada CANADA 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 Canada’s healthcare expenditure was projected to hit $344 billion in 2023, the overall healthcare expenditure in Canada is estimated at $8,740 per Canadian. This is expected to account for 12.1% of Canada's gross domestic product (GDP) in the same year. ​ Market Trend: Approximately 65 to 75 percent of Canadians have some form of supplementary health insurance. Canada ’s medical equipment market revenue is expected to show an annual growth rate (CAGR 2024-2028) of 6.36%, resulting in a market volume of US$14.10bn by 2028. The Health Sciences Authority (HSA) was formed in 2001 when voluntary registration was introduced. HSA regulates medical devices including IVDs under the Health Products Act 2007. All products are approved by the Medical Device Branch of HSA before it can be supplied in Singapore. Market Info Medical Device Regulation Canadian Medical Device Regulation (CMDR), under the MOH. https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/ Regulation Classification, Fees, Timeline C,F,T Registration Product Registration Routes Class I, II, III, IV Useful Information Validity of License: Needs to be renewed every year. License transfer: Not applicable. 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 ATTOPOLIS. Up

Cambodia Product Registration @ ARQon Business @ MedtechBOSS Global > ASEAN > Cambodia Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN CAMBODIA Medical devices are regulated by the Department of Drugs and Food (DDF) in the Ministry of Health in Cambodia whose objective is to ensure the quality and safety of medical devices that are locally produced or imported from other countries. They follow regulations that are in line with the ASEAN Medical Device Directive (AMDD). ​ MEDICAL DEVICE REGISTRATION AND APPROVAL IN CAMBODIA Recently, DDF clarified that the License Holder and Manufacturer can be a foreign company. But the registration dossier must be submitted by a local licensed pharmaceutical importer that employs a Cambodian pharmacist. The local pharmaceutical importer can prepare, sign and submit the application dossier, liaise with the DDF on the dossier, and receive the product registration certificate, all on behalf of the foreign manufacturer. Medical devices are classified into 4 categories namely class A, B, C and D (A being the lowest risk and D being the highest risk). If the classification has not yet taken place in any ASEAN jurisdiction, we would need to classify the product first by visiting the DDF. Lastly, please note family registration for medical devices is not available in Cambodia. Registration timeline usually takes six to twelve months, but delays are common. Sometimes authorities exercise their discretion during registration and delay procedures in an effort to solicit unofficial payments. Since we are bound by our firm’s zero-tolerance anti-corruption policy, we are strictly prohibited from making any unofficial payments to expedite action from the authorities. 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 Cambodia. ​ 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 Cambodia. ​ Read more drug Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Cambodia. ​ Contact Us for more details. Need more details? We are here to assist. Contact us at A TTOPOLIS Platform. ត្រូវការព័ត៌មានលម្អិតបន្ថែមទេ? យើងនៅទីនេះដើម្បីជួយ។ ទាក់ទងមកយើងនៅ ATTOPOLIS Platform ។ Up health

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services @ ARQ on Extra RA/QA Support Drug Services Health Safety Medical Device Product Registration License Holding Medical Device Product Registration to Obtain Approval from Authorities ARQon provides regulatory service and guidance to overseas and local manufacturers who are interested in supplying or trading their medical device in targeted countries. The checklist submission require ment for Medical Device Registration can vary depending on each country's requirements and classification, but we can register and be an in-country representative for your product. The support can be from pre-market to post-market as shown below: Obtaining approval for Product Registration for Medical Devices and/or Drug-device products by submitting a good dossier with proper planning for CE marked in EU, US, Asia including ASEAN and global; ​ In-Country product license holder ​ Post-market vigilance reporting with the understanding of local reporting and handling requirements for those countries; Establishment registration; and Other authorization and market access. View by Country 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

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services Services @ ARQ on Extra RA/QA Support Drug Services Health Safety Product Registration License Holding Regulatory Quality Support View by Country Update of regulatory news and Monthly Regulatory Support for Regional Registration ARQon provide monthly regulatory support in Americas, ASEAN, Asia, Middle East and Europe . 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

MID DLE EAST S AUDI ARABIA CONTACT US Global > Middle East > Saudi Arabia SAUDI ARABIA 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 USE FUL INFORMATION Market Information Saudi Arabia’s healthcare expenditure was 16.96 percent of its budget in 2023, amounting to $50.4 billion, will be allocated to healthcare and social development, making it the second largest expenditure after education. ​ Market Trend: The Health Insurance market's gross written premium is anticipated to achieve a value of US$4.43 billion by the year 2024. Saudi Arabia’s medical equipment market is expected to reach US$0.51 billion by 2024, with an anticipated compound annual growth rate (CAGR) of 2.82% from 2024 to 2028. The regulation of medical devices and in vitro diagnostics (IVDs) in Saudi Arabia is overseen by the Saudi Food and Drug Authority (SFDA). To market medical devices, including IVDs, in the Kingdom of Saudi Arabia (KSA), obtaining a Medical Device Market Authorization (MDMA) from the SFDA is mandatory. Market Info Medical Device Regulation Saudi Food and Drug Authority (SFDA) , under the MOH. https://www.sfda.gov.sa/en Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class A, B, C, D Registration Useful Information Validity of License: 3 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. Information Need more details? We are here to assist. Contact us at ATTOPOLIS Platform. هل تحتاج إلى مزيد من التفاصيل؟. نحن هنا للمساعدة. اتصل بنا على منصة ATTOPOLIS. Up

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services Services @ ARQ on Extra RA/QA Support Drug Services Health Safety Product Registration License Holding Pharmaceutical and Cosmetics View by Country We support local start-ups and sponsors in product development for drug, biologics or combination drug-device products. For overseas manufacturers, we also provide drug product registration . In some cases, gap assessment would be conducted to understand the success rate before product registration in certain countries. Our team has over 31 years of Global Regulatory experience. Biologics/NCE/Biosimilars Generic drugs, OTC, CTA, Health supplements / Food Supplements e.g. (Product Registrations/Renewals/Variation applications/PV management ) Labelling/Packaging/Supply chain consultation Advertising and promotion guidelines consultancy Audits (including clinical trial QA and regulatory oversight) e.g. (QA supplier audits, GMP audits, GDP, GCP, GLP audits) Animal testing updates for cosmetics GMP, GCP, GDP and ISO related consultation Staff training on APAC Regulatory affairs Review label claims for health authority approval Import and wholesale license submission Holding product licences/ Name patient basis application Meeting health authorites and providing Compliance support Gap analysis (manufacturing sites and dossier) Post marketing surveillance Complaints handling Recall handling Webinars/ Regulatory Intelligence Regulatory Strategy Development 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

AMERICAS USA CONTACT US Global > Americas > USA USA 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 USA’s healthcare expenditure witnessed a 4.1 percent growth in healthcare spending in 2022, amounting to $4.5 trillion, equivalent to $13,493 per person. This health spending represented 17.3 percent of the nation's Gross Domestic Product. ​ Market Trend: An estimated 304 million, or 92.1%, Americans had health insurance in 2022. Singapore’s medical equipment market is expected to show an annual growth rate (CAGR 2024-2028) of 5.49%, resulting in a market volume of US$225.40bn by 2028. The Food and Drug Administration (FDA), operating under the Department of Health and Human Services (HHS), oversees the safety and efficacy of medical devices. The Center for Devices and Radiological Health (CDRH), formed in 1982, plays a key role in the regulation of medical devices. Market Info Medical Device Regulation Center for Devices and Radiological Health (CDRH), under the FDA. https://www.fda.gov/about-fd a/fda-organization/center-devices-and-radiological-health Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class I General Controls, exempted from 510(k) submission. ​ Class II General Controls and Special Controls, requires 510(k) submission. ​ Class III General Controls and Premarket Approval (PMA) Registration Useful Information Validity of License: Indefinite, unless revoked or product recalled. Annual Establishment Registration is required. License transfer: Not necessary to notify FDA about the transfer of a 510(k) clearance (although the new 510(k) holder will be required to file device listing form FD-2892). 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 ATTOPOLIS. Up

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