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

    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 South Korea: Philippines FDA Listed Ministry of Food an... 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.”

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

    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 South Korea: Philippines FDA Listed Ministry of Food an... 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 | Privacy Policy | ARQon

    Privacy Policy We collect such Non-personal and Personal Information for the following purposes: To provide and operate the Services; To provide our Users with ongoing customer assistance and technical support; To be able to contact our Visitors and Users with general or personalized service-related notices and promotional messages; To create aggregated statistical data and other aggregated and/or inferred Non-personal Information, which we or our business partners may use to provide and improve our respective services; To comply with any applicable laws and regulations. ​ Our company is hosted on the Wix.com platform. Wix.com provides us with the online platform that allows us to sell our products and services to you. Your data may be stored through Wix.com’s data storage, databases and the general Wix.com applications. They store your data on secure servers behind a firewall. All direct payment gateways offered by Wix.com and used by our company adhere to the standards set by PCI-DSS as managed by the PCI Security Standards Council, which is a joint effort of brands like Visa, MasterCard, American Express and Discover. PCI-DSS requirements help ensure the secure handling of credit card information by our store and its service providers.

  • Medical Device Consulting | Business | Asia | ARQon MedtechBOSS

    Product Registration GMS Doc CE BM India Product Registration @ ARQon Business @ MedtechBOSS Global > Asia > India 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 India. 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 India. Contact Us for more details. CE Corporate Expansion BUSINESS REGISTRATION AND INCORPORATION MedtechBOSS provides Business Registration and Business Incorporation in India. Contact Us for more details. BM Business Matching DISTRIBUTOR AND PARTNER SEARCH MedtechBOSS provides Distributor Search, Company Incorporation with Partners in India. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. अधिक विवरण चाहिए? संपर्क करें। हम यहां सहायता करने के लिए हैं। एटोपोलिस प्लेटफॉर्म पर हमसे संपर्क करें। Up

  • Medical Device Consulting|Registration|Australia|TGA|Regulation|ARQon

    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

  • Copy of Thailand Registration | ARQon

    Thailand Product Registration @ ARQon Business @ MedtechBOSS Global > ASEAN > Thailand Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN THAILAND Medical devices are regulated by the Medical Device Control Division (MDCO) from the Food and Drug Administration (FDA) in Thailand (also known as Thai FDA) whose mission is to regulate and monitor health products so as to meet quality and efficacy requirements. Medical devices are regulated under the Medical Device Act B.E. 2531 (A.D. 1988). The approval process in Thailand for Class III general medical devices (lowest risk) is relatively fast and easy . Due to its simple registration process, the manufacturer should consider penetrating this market if the manufacturer is dealing with a Class III general medical device. Most of the medical devices in Thailand is a Class III general medical device (lowest risk), including drug-eluting coronary stent and catheter system. MEDICAL DEVICE REGISTRATION AND APPROVAL IN THAILAND Medical devices in Thailand is classified into 3 categories namely Class I, II and III. Unlike the risk classification convention adopted by most countries, category I devices in Thailand are considered the riskiest medical device and category III devices are considered the lowest risk device. Category I (Licence Medical Devices) Manufacturer, importer and distributor must have their medical devices approved by the Thai FDA before importing/supplying products in Thailand. Medical devices belonging to this category are: 1. Condoms 2. Examination gloves 3. Surgical gloves 4. Sterile Hypodermic Disposable Syringes 5. Sterile Insulin Disposable Syringes 6. HIV Test Kits for Diagnostic use 7. Contact Lens The manufacturers and importers of HIV Test Kits for Diagnostic use must hold a quality control accreditation. Furthermore, distributor and seller of this product must obtain a HIV Test Kits for Diagnostic use licence for the premise. Category II (Notification Medical Devices) Manufacturers, importers and distributors must notify the Thai FDA about their medical device to before importing/supplying products in Thailand. Medical devices belonging to this category are: 1. Physical therapy products 2. Alcohol Detector 3. Implanted Silicone Breast Prosthesis 4. Breast enhancement 5. HIV test kit (for researching and studying) which not for registration Category III (General Medical Devices) Medical devices that do not fall into categories I and II can be classified under category III. An import license must be obtained from the Thai FDA before the device can be imported to, or sold in Thailand. Dossier requirements Although the risk classification is reverse categorized in Thailand, the amount of evidence needed to prove the safety and efficacy of the device would be proportionate to the risk of the device, just like most countries. For Licence and Notification of medical device application, Thai FDA expects the dossier to be submitted in Common Submission Dossier Template (CSDT) format . Based on ARQon’s experience, the CSDT dossier must also be included with the country-specific requirements for the specific product in order to obtain faster product approval. Furthermore, ARQon’s director has also helped the Thai FDA in the CSDT evaluation requirements for the licence medical device. General medical device application is one of the easiest and fastest product registration processes compared to a lot of countries. The approval is relatively fast so long as the few documents and database are prepared in the right format for Thai FDA. Note that Free sale certificate is required in the submission, which means that the product must be approved in the country of the manufacturer before submission can be made to Thai FDA. In Thailand, the product license holder must also be the same importer and distributor . ARQon can help companies to obtain product license and import products to Thailand. Process with ThaiFDA 1. Applicants must submit the required documents to the Thai FDA service center; 2. The submitted documents are reviewed and recorded by a regulator of the Medical Device Control Division; 3. A staff member records the applicant’s files into a database system, and the applicant is provided with a reference number and receipt; 4. The applicant obtains the letter of approval for importation. The Certificate of Free Sale is no longer required for the registration of medical device in Thailand. The Common Submission Dossier Template (CSDT) is needed instead. Example Of Approval DOWNLOAD 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 Thailand. ​ 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 Thailand. ​ Read more drug Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Thailand. ​ Contact Us for more details. Need more deta ils? We are here to assist. Contact us at A TTOPOLIS Platform. ต้องการรายละเอียดเพิ่มเติม ? เราอยู่ที่นี่ เพื่อช่วยเหลือ ติดต่อเราได้ที่แพลตฟอร์ม ATTOPOLIS. Up health

  • Medical Device Consulting | Registration | Middle East | ARQon

    Product Registration Product Registration Extra RA/QA Suppprt Drug Services Health Safety Egypt Product Registration @ ARQon Business @ MedtechBOSS Global > Middle East > Egypt Product Registration Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN EGYPT Medical Device is regulated by the Central Administration for Pharmaceutical Affairs (CAPA) from the Egyptian Drug Authority (EDA) whose objective is to ensuring that the community has access to safe, effective affordable & secure products. MEDICAL DEVICE REGISTRATION AND APPROVAL IN EGYPT Medical devices are classified into 4 categories namely class I, IIa, IIb and III (I being the lowest risk and III being the highest risk) and is based on CE classification. CE Marking for the Medical Device is highly recommended to get a registration approval from CAPA. Example Of Approval DOWNLOAD Source: CAPA 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 Egypt. 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 Egypt. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Egypt. 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

  • Medical Device Consulting | Registration | ASEAN | ARQon

    Product Registration Product Registration License Holding Extra RA/QA Suppprt Drug Services Health Safety Philippines Product Registration @ ARQon Business @ MedtechBOSS Global > ASEAN > Philippines Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN PHILIPPINES Centre for Device Regulation, Radiation Health, and Research (CDRRHR) is now shifted to the Food and Drug Administration (FDA), from the Department of Health in the Philippines. CDRRHR's objective is to protect and promote the right to health of the Filipinos and to establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems. Medical devices are regulated under the Republic Act No. 9711, the Food and Drug Administration Act of 2009. MEDICAL DEVICE REGISTRATION AND APPROVAL IN PHILIPPINES Only local establishments issued with a License to Operate (LTO) can register medical devices in the Philippines. The local medical device importer, distributor (importer, exporter, and wholesaler), trader and manufacturer are subjected to LTO by CDRRHR. There are 2 types of certificate application in the Philippines relating to medical devices: Certificate of Product Registration (CPR) for registrable medical devices including In-vitro Diagnostic Kits and Reagents There is a list of registrable medical devices that are subjected to CPR. Products are also classified into 4 classes as Class A, Class B, Class C and Class D from the lowest risk to highest risk where the relevant fees are applicable. Currently, there is a list of documents that are required to be submitted to CDRRHR, including the product testing reports. ASEAN CSDT dossier format is not mandatory currently until the new Administrative Order is implemented. Proper planning on the documentation before submission is important because there will be increased fees or penalty for some application types if proper submissions are not made to CDRRHR. Certificate of Exemption for Non-Registrable Medical Devices Example Of Approval DOWNLOAD - Library Medical device regulatory guidelines View All Library Up Product Registration License Holding Extra RA/QA Suppprt 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 Philippines. 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 Philippines. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Philippines. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. Kailangan ng higit pang mga detalye? Makipag-ugnayan sa amin. Nandito kami para tumulong. Makipag-ugnayan sa amin sa ATTOPOLIS Platform. Up

  • Medical Device Consulting|Registration|Turkey|TMMDA|Regulation|ARQon

    ASIA TURKEY CONTACT US Global > Asia > Turkey TURKEY 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 Turkey’s healthcare expenditure surpassed 606.8 billion Turkish lira in 2022. From 2000 to 2022, healthcare spending exhibited remarkable growth, notably accelerating in the last four years, with health expenditure more than tripling since 2019. ​ Market Trend: In 2003, the Republic of Turkey implemented a decade-long health system reform aimed at ensuring universal health coverage. The effectiveness of this reform is evident in the rise of individuals covered by public health insurance, soaring from 70 percent in 2002 to nearly 90 percent by 2021. Concurrently, the percentage of the Turkish populace possessing private health insurance has also shown a rise during this period. ​ Turkey’s medical equipment market r evenue is expected to show an annual growth rate (CAGR 2024-2028) of 5.16%, resulting in a market volume of US$6.42bn by 2028. The Turkish Medicines and Medical Devices Agency serves as the foremost regulatory body under the Government of Turkey, holding the highest authority in ensuring medical safety concerning medicines, healthcare items, cosmetics, and personal care products. Market Info Medical Device Regulation Turkish Medicines and Medical Devices Agency (TMMDA), under the MOH. https://www.titck.gov.tr/Dosyalar/Erisim/TMMDABrochure.pdf Regulation Classification, Fees, Timeline C,F,T Product Registration Routes Class I, IIa, IIb, III, AIMD (Medical Devices) ​ Class A, B, C, D (In Vitro Diagnostic Devices ) ​ Registration Useful Information Validity of License: No validity. ​ 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 A TTOPOLIS Platform. Daha fazla ayrıntıya mı ihtiyacınız var? ​ Yardımcı olmak için buradayız. ATTOPOLIS Platformunda bize ulaşın. Up

  • Medical Device Consulting | Registration | Middle East | ARQon

    Product Registration Product Registration Extra RA/QA Suppprt Drug Services Health Safety Saudi Arabia Product Registration @ ARQon Business @ MedtechBOSS Global > Middle East > Saudi Arabia Product Registration Extra RA/QA Support Drug Services Health Safety Product Registration MEDICAL DEVICE REGULATION IN KSA Medical Device is regulated by the Saudi Food and Drug Authority (SFDA) in KSA whose objective is to protect and maintain public health within the KSA by the implementation of provisions ensuring a high level of safety and health protection of patients, users and third parties with regard to the use of medical devices as it relates to their manufacture, supply and use during their lifecycle. Medical devices are regulated under the Medical Device Interim Regulation. MEDICAL DEVICE REGISTRATION AND APPROVAL IN KSA The registration requirements carries elements from both Global Harmonization Task Force (GHTF). Devices shall comply with the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA, and additionally with provisions specific to the KSA to obtain registration approval. Example Of Approval DOWNLOAD Source: SFDA 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 Saudi Arabia. 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 Saudi Arabia. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Saudi Arabia. Contact Us for more details. Need more details? Contact us We are here to assist. Contact us at ATTOPOLIS Platform. هل تحتاج إلى مزيد من التفاصيل؟ اتصل بنا. نحن هنا للمساعدة. اتصل بنا على منصة ATTOPOLIS. Up

  • Medical Device Consulting | Registration | EUROPE | ARQon

    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

  • Medical Device Consulting | Library | ARQon Gazette News

    Gazette New s News, insights and highlights May 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 South Korea: Philippines FDA Listed Ministry of Food an... View All Blogs Up Events Our upcoming events are posted in ATTOPOLIS View All Events

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