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

    ARQon Regulatory & Medical Device Registration Services 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 Discovery of Talented Innovative Jewels of Future Generations View All Highlights Up Blogs Latest regulatory update Singapore: UDI Phase 2 Compliance Date Approaching (w.e... 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 | Gazette News | ARQon

    Gazette New s News, insights and highlights March 2024 Highlights / Press Release Blogs Library Gazette Highlights / Press Release Our past events and highlights View All Highlights Up Discovery of Talented Innovative Jewels of Future Gener... Deep Dive into Indonesia’s Fashion and Lifestyle Dynami... Remote Monitoring Technologies for Elder Care... Blogs Latest regulatory update View All Blogs Up Singapore: UDI Phase 2 Compliance Date Approaching (w.e... Argentina: ANMAT Reviewing Changes to Sales Conditions ... Hong Kong: CP-05 for Listed Medical Devices Distributor... Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS

  • Medical Device Consulting | Blogs | ARQon Gazette News

    Gazette New s News, insights and highlights Featured Highlights / Press Release Blogs Library Gazette Blogs Latest regulatory update 22 hours ago Singapore: UDI Phase 2 Compliance Date Approaching (w.e.f 1 November 2024) The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the... 2 days ago Argentina: ANMAT Reviewing Changes to Sales Conditions for Medicinal Specialties (21 March 2024) Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution... Mar 20 Hong Kong: CP-05 for Listed Medical Devices Distributors by MDD (1 March 2024) On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device... Mar 19 Taiwan: Essential Insights into Medical Mask Registration Requirements (15 March 2023) Following the amendment for the Medical Mask (CNS 14774 (T5017)) and Disposable Dust Respirators (CNS 14755 (Z2125)) under the... Mar 14 UK: New Guidance for Established Medicines Marketing Authorization Application Process Changes (w.e.f 1 March 2024) Effectively from 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released new process changes for the... Mar 6 Singapore: Final Phase for Transition of the ISO 13485 Certification Granted by SAC-Accredited Body for Medical Device Dealer License Applications (w.e.f 1 January 2025) Health Sciences Authority issued a reminder about the final transition year for all medical device dealers to obtain confirmation from... Feb 28 Switzerland: Updated Application Documentation for Medicinal Product Establishment License Discontinuation (w.e.f 9 January 2024) Generally, companies that intend to manufacture and/or distribute medicinal, transplant, gene therapy products, or genetically modified... Feb 27 Singapore: Latest Iteration of the Medical Device Product Registration Guidance (GN-15) (24 January 2024) The Health Sciences Authority (HSA) recently revised the guidance of the medical device product registration (GN-15) under Revision 10... Feb 21 Philippines: Revision in Application Process for CMDR/CMDN, Initial & Renewal (10 January 2024) Effectively starting from 10 January 2024, all initial applications for Certificate of Medical Device Registration (CMDR) and renewal... Feb 20 India: Sampling Regulatory Framework for Drugs, Cosmetics, & Medical Devices for Drug Inspectors (9 February 2024) The Central Drugs Standard Control Organization (CDSCO) released a circular of the regulatory guidelines for the sampling procedure of... Feb 14 New Zealand: EPA Enforces Ban PFAS Usage in Cosmetic Products (31 December 2026) & Amendments to Cosmetic Products Group Standard (25 January 2024) On the 30th January 2024, the Environmental Protection Authority (EPA) decided to eliminate Per/Poly- fluoroalkyl substances (PFAS) in... Feb 7 UK: 2 New Approved Bodies Appointed for MHRA to Certify Medical Devices (31 January 2024) On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the appointment of 2 new Approved Bodies,... 1 2 3 4 5 Highlights / Press Release Our past events and highlights Discovery of Talented Innovative Jewels of Future Gener... View All Highlights Up Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS View All Events Up

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Blog Posts (519)

  • Singapore: UDI Phase 2 Compliance Date Approaching (w.e.f 1 November 2024)

    The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the upcoming Phase 2 – UDI Implementation, effective starting from 1 November 2024, involving all general medical devices under Class D and In Vitro Diagnostic (IVD). Class D medical devices consisted of high-risk devices, for example, implantable defibrillators, pacemakers, and heart stents. Registrants were advised to voluntarily update all UDI-related data in the Medical Device Information and Communication System (MEDICS) before the compliance date, to facilitate and ensure a smooth transition period. All medical devices are compulsory to be registered with HSA before the product placement in Singapore. While medical devices that are supplied after the compliance date for each risk class, are compulsory to comply with the UDI requirements. Six (6) six-month transition period is provided from the compliance date to facilitate companies with products that have been imported and exist in the current supply chain. Source: Health Sciences Authority (HSA) Contact us at info@arqon.com for more information.

  • Argentina: ANMAT Reviewing Changes to Sales Conditions for Medicinal Specialties (21 March 2024)

    Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution 284/2024 to review and propose modifications to the sale condition of the medicinal specialties, with minimum 5 years permanence in the national market, without any quality, safety, and efficacy issue, under the prescription sale, to obtain free sale declaration. ANMAT as a decentralized body with jurisdiction has been authorized to supervise, control, and guarantee all medicinal products comply with the technical requirements of the reference or recommendation organization and are in top condition for use. The nature or possible risks of the improper use of medicines and condition of sales (over-the-counter, prescription, archived prescription, and prescription and decree) are included in the decision of ANMAT to grant the “Free Sale” condition. The status of “over-the-counter” may be declared to any medications developed for minor ailments without requiring any medicinal professional interventions and, able to be considered safe, due to the formulations, usage, conditions, planned doses, and wide safety margin that does not entail dangers for the patients. Source: Ministry of Health Contact us at info@arqon.com for more information.

  • Hong Kong: CP-05 for Listed Medical Devices Distributors by MDD (1 March 2024)

    On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device distributors in Hong Kong, aiming to stipulate the requirements that have to be complied with by the distributors. The requirements listed by MDD include the scope of: Premises and Equipment Implementation and Maintenance of Procedures Inspections Advertisement and Promotional Materials Notification of Changes Notification of Renewal of Inclusion on the Listed Distributor The Listed Distributor is required to establish a properly manned premise in Hong Kong, including but not limited to, an office, receiving/delivering area, and maintenance area, in which the distributions will take place. It is important to ensure the condition is clean and complies with the instructions stated on the label. The premise should keep a record of the temperature data and ensure all measuring equipment is inspected from time to time. All distribution and post-market activities must be documented as conformity evidence to establish the necessary controls for identification, storage, security, retention time, and disposition. The Listed Distributor should retain the records for seven (7) years or the projected service life of the medical devices, whichever is longer. All the supply records and updated lists of medical devices distributed should be documented with the make, model, batch number, serial number, quantity of the medical device, and other sufficient information needed for tracking or withdrawal. An action under CAPA would be taken if the Listed Distributor fails to ensure all the documented procedures are reviewed regularly. Supply records and documented procedures should be ready to be inspected by the MDD and Listed Distributors must be able to submit other requested documents within the specific timeline given, including the premise inspection. Submission of Renewal and Change Application Form for Listed Importers/Distributors (MD 203) should be submitted not later than four (4) weeks after the changes made to the submitted distributors particulars and MDD may request evidence documentary of the change within two (2) weeks. While, renewal of current inclusion on the List of Distributors must be submitted under Renewal and Change Application Form for Listed Importers/Distributors (MD 203) not less than three (3) months and not more than six (6) months prior the expiry. If the renewal submitted after the expiry of the current listing, the listing will be invalid and shall not be purported as a Listed Distributor until approved by the MDD. Distributor may apply for inclusion on the List of Distributors if the current listing expired. Delisting MDD has the authority to cease the Listed Distributor from the current listing if the party fails to comply with the MDACS requirements, fails to address any situation that rise the public safety concern or medical device hazards, or, requested by the Listed Distributor. Appeal Distributor may appeal the decision from the Distributor Listing Approval Board on application rejection or Listed Distributor removal within fourteen (14) working days of being notified, but that does not suspend the delist decision from MDD. The appeal outcome will be notified to the distributor within four (4) weeks upon the appeal application submission (including the supporting documents, if requested). Source: Medical Device Decision (MDD) Contact us at info@arqon.com for more information.

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