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Services @ ARQ on Group ARQon Registration MedtechBOSS ATTOPOLIS B2B International Medical Device School ATTOMATCHING QuikQuality 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 Australia: TGA Adopts 2021 Sunscreen Standard (w.e.f 1 ... 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.”

Agenda Registration Enquiry INVITATION TO MEDICA ASIA'S RECEPTION DINNER IN CONJUNCTION WITH ARQON 10th ANNIVERSARY You're invited to MEDICA Asia's reception dinner and ARQon's 10th-anniversary celebration. Join 500 local and global partners, healthcare professionals, and stakeholders from Medtech/Biopharma, including Ambassadors, Government Officials, Trade Commissioners, Associations, and Healthcare Innovation Centers. ​ At ARQon, we provide comprehensive solutions including advisory, compliance, QA, documentation, training, and networking. Your support over the past decade has been invaluable. Join us at our anniversary celebration to celebrate our shared achievements and explore future collaborations. Please consider supporting our event. Thank you for being part of our journey. We look forward to celebrating with you. Date 10 September 2024 Day Tuesday Time 6 pm - 11 pm Venue Marina Bay Sands 10 Bayfront Avenue, Singapore 018956 Heliconia Ballroom, Level 3

Celebrating 10 Years: Anniversary & Dinner Reception Registration Category Register

ARQon 10th Anniversary Agenda 10 September 2024 GMT +8 Venue: Helconia Ballroom, L3 06:00 - 07:00 PM Cocktail reception and Showcasing Startup Medical companies ​ 07:00 - 07:20 PM Guests to be seated ​ 07:20 - 07:35 PM Arrival of Guest of Honour (GOH) If time permits, 10 mins close-door prior introduction of Key Partners ​ 07:35 - 07:50 PM Welcome Speech & ARQon 10-year journey ​ 07:50 - 08:05 PM Keynote Speaker by GOH ​ 08:05 - 08:20 PM GOH to Witness MOU Signing for Key Partners from SingHealth Innovation Centre, A*STAR HealthTec, Temasek Polytechnic, APACMed, Messe Medica and Key Sponsors ​ 08:20 - 08:35 PM Physical Cake cutting ceremony ​ 08:35 - 08:45 PM Dinner ​ 08:45 - 09:15 PM Market Trend for Medical & BioPharma Industries by PwC ​ 09:15 - 09:35 PM Award Ceremony for Best Achievement Employees in Medical & BioPharma Industries ​ 09:35 - 10:00 PM Business and Work-Life Balance Sharing ​ 10:00 - 10:45 PM Lucky Draw ​ 10:45 - 11:00 PM Picture Taking ​ 11:00 PM End of Event

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

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

Product Registration Product Registration Extra RA/QA Suppprt Drug Services Health Safety Switzerland Product Registration @ ARQon Business @ MedtechBOSS Global > Europe > Switzerland Product Registration Extra RA/QA Support Drug Services Health Safety Product Registration Contact Us for more details. Example Of Approval Not Avaliable - Product Registration Extra RA/QA Suppprt Extra RA/QA Support MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION Contact Us for more details. Drug Services Drug Services THERAPEUTIC AND COSMETIC APPROVAL Contact Us for more details. Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ 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 Mexico Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > Americas > Mexico Medical Device Product Registration and Approval ​MEDICAL DEVICE REGULATION IN MEXICO ​ Medical Device is regulated by The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health in Mexico. Its primary objective is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, that provides unity and homogeneity to the policies which are determined. ​ MEDICAL DEVICE REGISTRATION AND APPROVAL IN MEXICO ​ Medical devices are classified into 3 categories namely class I, II, and III (I being the lowest risk and III being the highest risk). The registration requirements are similar to the European Union(EU) with the main focus being on documents from the technical file. An expedited registration route applies if the device has been approved in US or Canada. Example Of Approval DOWNLOAD Source: COFEPRIS 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 Mexico. 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 Mexico. Read more Health Safety Health Safety WIRELESS, RADIATION AND PACKAGING APPROVAL ​ ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Mexico. 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

About U s Our Team Our Clients Testimonials Company Company ARQon is a regulatory consultancy for medical devices and drug companies. We assist our clients in aspects of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World. Our range of clients includes researchers, manufacturers and traders from both start-ups and MNCs. Additionally, ARQon provides training sessions for researchers, manufacturers and regulators. Vision To be world-class regulatory service provider and to contribute to healthcare. Mission To leverage our team's expertise in regulatory, commercial and connection to assist our clients in global market strategy, resolving issue, complying with the regulatory requirement and obtaining approval to meet the quality, safety and effectiveness for medical device, therapeutic and drugs usage. We aim to contribute our comprehensive services to Healthcare industry and MedTech community globally.​​ Team We are formed from individuals with vast experiences in medical device and drug manufacturing sites, trading industry and in regulatory authority. ​ With regulatory authorities background, we balance the nation's requirement for patients safety with the need to foster and advance medical options in an environment to limited resources, We have experience in the manufacturing environment from start-ups to MNCs, from greenfield sites to mergers and acquisitons. We understand manufacturing targets, needs and limitations, We have experience obtaining global registration from CE, US, Asia, ASEAN, and rest of the world (ROW). As a key partner to the sales and marketing function, we can pave the way to generate revenue and meet business targets, We together share the same mission, we contribute to healthcare. Company Global Regulatory & Quality Director, ARQon group CEO ​ ​ Bsc (Biochem & Microbio) MSc (BioMedical Eng) Grad Dipl (Medtech Manufacturing) May Read more Medical Device: Combination, Implants, IVDs Global Product Registration, QMS, Audit ex: HSA, Biosensors ASEAN-China & Singapore agencies advisors and committee, International speaker Origin: Singapore, Malaysia, ASEAN ARQon Team Biologics & Drugs ​ PhD in Mic robiology Stephen Read more Regulatory & Quality Consultant ​ Bsc Mechanical Engineering Ray Read more Biologics & Drugs GMP, GLP, GDP, GDPMD ex: HSA, GSK, Teva Origin: US, Taiwan ROC, Singapore Global Product Registration, ISO13485, FDA, QMS ex: Oculus (MR), Illumina Origin: Singapore Regulatory & Quality Consultant ​ Diploma in Biomedical Engineering Trish Global Product Registration Origin: Singapore, Philippines Regulatory & Quality Consultant ​ Diploma in Biomedical Engineering Beatrice Global Product Registration Origin: Singapore Regulatory ​ ​ ARQon Malaysia Azmina Read more Regulatory Affairs Origin: Malaysia Our Team Our Clients Testimonials Regulatory & Quality Associate Diploma in Materials Science Kah Suan Read more Regulatory Affairs Origin: Singapore ​Senior Corporate Administrator ​ ARQon Singapore Bing Kang HR Affairs Origin: Singapore Inquiries for Staff Our Clients What Our Clients Say “ARQon has help AWAK achieve zero non-conformity during our ISO 13485: 2016 Quality Management Audit is not an easy feat to achieve. We like to thank them for their dedication and commitment in their work.” “ARQon has help to complete the MDSAP gap analysis in a timely and professional manner and as a result we have reached a new milestone in achieving MDSAP certification effortlessly for MediPurpose.” Services @ ARQ on Group Check out our services ARQon MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global Market Strategy Technical Documentations Corporate Expansion Business Matching Business Hub ATTOPOLIS IMDS B2B Marketplace Forum Events Training Need more details? We are here to assist. Contact us at ATTOPOLIS. Up

AMERICAS ASEAN ASIA & OTHERS MIDDLE EAST EUROPE Services Services @ ARQ on Extra RA/QA Support Drug Services Health Safety Product Registration License Holding License Holding CE Rep & CE Marking Before the medical device can be marketed and supplied in the European market, the manufacturer must appoint an EC Representative for manufacturers not based in Europe. The product must be affixed with the EC Rep and the CE marking by undergoing conformity assessment to demonstrate the device has met the essential requirements defined in the applicable requirements in: European Medical Device Regulation (MDR 2017/745), with 3 years transition and extended until effective on 26 May 2021 In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746), with 5 years transition until effective on 26 May 2022 EU MDD/AIMDD/IVDD directives ​ ​ View by Country UK Rep & UKRA Marking From 01 Jan 2021, companies need to register their product with MHRA to gain market entry in UK. UK Rep, UKCA marking, Labelling and Product registration are required. There are different grace period for different risk classification of the product and different country/region in Great Britain (GB), Northern Ireland (NI) and European Union (EU). ​ For UK Rep or UK responsible person, it has to be appointed by manufacturers that are not based in UK. ​ For UKCA marking, companies assessed the conformity via UK-appointed Approved body such as BSI to obtain UKCA (0086). ​ Below table summarizes highlights various requirements and timeline for GB, NI and EU in order to comply with the transition on UKCA marking Post Brexit. ​ EU MDD/AIMDD/IVDD directives ​ Source: Webinar on UKCA Marking – EEN (The webinar was jointly organized by Singapore Manufacturing Federation and Enterprise Europe Network. Supported by Enterprise Singapore & BSI.) ​ Key Q&A: ​ Q1. What are the product marking that can be used in the UK? ​ Ans: A product with both UKCA and CE will be able market in GB, NI and EU. A product with only CE will still be able to market in NI and EU, however CE will be allowed until 30 Jun 2023 in GB. A product with only UKCA can be used from 01 Jan 2021 in GB and it is mandatory from 01 Jul 2023. In NI and EU, UKCA marking alone is not accepted. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Q2. What are the transitions expected on labelling for Post Brexit non-UK and UK manufacturers? ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Q3. What are the product registration requirement for UK market? ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Q4. How is the transition taking place in the GB market after 01 Jan 2021? ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Swiss Rep Switzerland is preparing a national Medical Device ordinance (MepV), as reported by Swiss MedTech. The country is thus prepared to no longer be a direct part of the EU system, Because the negotiations with the EU are likely to fail. Due to these changes, manufacturers from outside Switzerland are only allowed to market their medical devices in Switzerland if they have a Swiss Rep. Transition periods discussed in this context are: December 2021: Class III, Class IIb implantable devices, active implantable devices March 2022: Class IIa, Class IIb non-implantable devices July 2022: Class I, Systems and procedure packs Article ​ ​ US 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 ​ ​ 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 ​ ​ 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. ​ 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 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

EUROPE ITALY CONTACT US ITALY Product Registration @ ARQon Business @ MedtechBOSS Product Registration License Holding Extra RA/QA Support Drug Services Health Safety Global > Europe > Italy MARKET INFO I REGULAT ION I CLASSIFICATION, FEES & TIMELINE I REGISTRATION ROUTES I USEFUL INFORMATION Market Information Italy’s healthcare expenditure has increased steadily over the years, with spendings of approximately $4291 per capita on health in 2023, which is less than the OECD (Organisation for Economic Co-operation and Development) average of $4986 (USD PPP). This is equal to 9.0% of GDP, compared to 9.2% on average in the OECD. ​ Market Trend: The Italian government provides low to cost-free healthcare for its residents, with public health insurance provided. Italy’s medical equipment market is expected to have a revenue of approximately 14.91 billion USD by 2028 . Market Info Medical Device Regulation National Database of Medical Devices in accordance with the Ministry of Health https://www.salute.gov.it/portale/saluteBambinoAdolescente/dettaglioContenutiSaluteBambinoAdolescente.jsp?id=5715&area=saluteBambino&menu=vuoto ​ Med Dev Reglulation Classification, Fees, Timeline 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 Italy. Classification 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. Hai bisogno di maggiori dettagli? Siamo qui per aiutare. Contattaci alla piattaforma ATTOPOLIS. Up