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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

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

On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory Authority Agency, which is expected to facilitate pharmaceutical exports to the Philippines. The approval period for pharmaceutical registration will be significantly reduced estimated to one (1) month via the Facilitated Review Pathway (FRP). Previously, the approval period to enter the Philippines market would take four (4) to six (6) months. Korea hopes the FRP system will increase the export rate of local pharmaceutical products. MFDS has maintained an excellent performance by gaining few achievements in the last few years. In October 2023, MFDS was listed in the WHO-Listed Authorities (WLA) and obtained the highest grade in the WHO Global Standard (GBT) Evaluation of the Pharmaceutical and Vaccine Regulatory System in 2022. Source: Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Contact us at info@arqon.com for more information.

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.