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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 Forging Expertise, Nurturing Innovations View All Highlights Up Blogs Latest regulatory update Philippines: Regulatory Flexibility Extension for the U... 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.”

Gazette New s News, insights and highlights April 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 Philippines: Regulatory Flexibility Extension for the U... View All Blogs Up Events Our upcoming events are posted in ATTOPOLIS View All Events

Gazette New s News, insights and highlights April 2024 Highlights / Press Release Blogs Library Gazette Highlights / Press Release Our past events and highlights View All Highlights Up Forging Expertise, Nurturing Innovations... Bridging Diplomacy, Cultivating Collaborations... Established Strong Connections, Tightened the Community... Blogs Latest regulatory update View All Blogs Up Philippines: Regulatory Flexibility Extension for the U... Malaysia: Directive Overview of Natural Product Registr... Australia: Proposed Revision of Manufacturing Principle... Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS

The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26 March 2024. The extension is intended to assist medical device industries with ample time in preparing the technical documentary requirements to apply for a Certificate of Medical Device Registration (CMDR) for Class B, C, and D that are not listed in the registrable medical devices list. Referring to the previous circular (FDA Circular 2021-002-C), PFDA has extended the flexibility period for industry players to manufacture, import/export, distribute, transfer, sell, or offer for sale without CMDN until 31 March 2024. PFDA took quick action to provide a further extension to avoid market disruption while assisting industries in complying with the ASEAN CSDT requirements in applying for CMDR. Here are the latest regulatory flexibility guidelines The Market Authorization Holders (MAHs) with valid CMDN of Class B, C, and D medical devices were advised to apply for CMDR within its validity period to ensure smooth continuous availability of market authorization. A copy of CMDN shall be attached with the statement letter to state that the application is from CMDN to CMDR. MAHs may use the issued CMDN and payment proof for CMDR application at the point of entry and/or as part of bidding requirements during the application process to continue the business activities (manufacture, import, export, distribute, sell the products). Hence, this circular effectivity automatically modified, repealed, and/or revoked the FDA Circular 2021-002-C. You may refer to our article about the previous regulatory flexibility extension here Source: Philippines Food and Drug Administration (PFDA) Contact us at info@arqon.com for more information.

The Drug Control Authorities (PBKD) agreed to register natural products based on the Guideline on Natural Products with Modern Claim, effective on 4 April 2024, under the provision of Regulation 9, Drug and Cosmetics Control Regulations 1984 (PKDK 1984). Previously, Malaysia only permitted two (2) types of claims for natural products which are Traditional Claims for general health and/or Therapeutic Claims for alleviating mild symptoms. However, there are demands and research that support and call for approval action to claim natural products as other than traditional and therapeutic claims, and these needs were not stated in any registration guidelines for natural products. Hence, NPRA writes out a Guideline on Natural Products with Modern Claims to cater to the demands and needs and align with the strategies of Traditional and Complementary Medicine (T&CM) Blueprint 2018-2027 (Health Care) in reinforcing the T&CM regulations and medicinal materials. IMPLEMENTATION OVERVIEW Natural product registration will be evaluated under Abridged Evaluation The duration of product registration is 116 working days for Single Products and 136 working days for Combined Products. Manufacturers are not obligated to obey the OECD Good Laboratory Practise (GLP) but must comply with the Guidelines on GMP for Traditional Medicines and Health Supplements. Certificate of Analysis (COA) must be submitted with testing documentation as listed in the Guidelines of Natural Products with Modern Claims. 2 batches of COA needed for local and imported products. Labelling statement required: “This is a herbal medicine/preparation”. The product category in the QUEST 3+ System is Herbal (medium). All product registration holders and manufacturers should take on of the newly approved claim under natural product registration. Now, there are three (3) types of natural product claims can be implemented in the product registration. Source: National Pharmaceutical Regulatory Agency (NPRA) Contact us at info@arqon.com for more information.

Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles for manufacturing medicines, active pharmaceutical ingredients (API), and sunscreens. However, the principal adoption does not apply to Annexes 4, 5, and 14. Key changes adopted in the latest guide are: Annex 13: Updated information and requirements to address issues related to the manufacture of investigational medicinal products Annex 16: Providing information and requirements of the certification by the authorized person and on the batch release of medicinal products Manufacturers are advised to ensure the requirements stated in the PIC/S Guide to GMP – 1 February 2022, PE009-16 are relevant to your manufacturing operations. GMP Inspectors are expected to apply the new guide during inspections starting from the commencement date. Hence, it is expected all manufacturers able to comply with the guide and adoption. Source: Therapeutic Goods Administration (TGA) Contact us at info@arqon.com for more information.