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Starting 1 July 2024, the Therapeutic Goods Administration (TGA) will adopt the 2021 Sunscreen Standard (Australian/New Zealand Standard (AS/NZS) 2604:2021) into the legislation. The updated standard as published by Standards Australia will provide the updated testing and labeling requirements for sunscreens marketed in Australia. Hence, all new sunscreen products included in the Australian Register of Therapeutic Goods (ARTG) must comply with the 2021 Sunscreen Standard. Five (5) years of transition period is given to all existing sunscreen products (aerosol and non-aerosol) included in the ARTG before 1 July 2024 will be given to comply with the testing requirements under the 2021 Sunscreen Standard. While existing aerosols and spray pump packs included in the ARTG before 1 July 2024 will have one (1) year transition period to comply with the required labeling requirements in the 2021 Sunscreen Standard. Source: Therapeutic Goods Administration (TGA) Contact us at info@arqon.com for more information.

Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device Authority (MDA) according to Section 5(1) of Act 737. However, there are no specific prohibitions for the registration of medical devices imported from/exported to countries that do not have diplomatic relations with Malaysia or that are subjected to trade restrictions. Establishments only obey the policies the Royal Malaysian Customs Department imposes and any latest policies issued occasionally. Hence, effectively from 26 April 2024, MDA Board Meeting No.1/2024 has approved one registration procedure flow for medical devices imported from/exported to countries without diplomatic relations that are subjected to trade restrictions, automatically revoking the previous circular letter of the MDA No.4/2014 (Revision 1). Establishments must obtain an Approved Permit – AP from the relevant agency, as approval for the import/export license, as outlined in the Customs (Prohibition of Imports) Order and Customs (Prohibition of Exports) Order. AP Possession will be an additional criterion for medical device registration with MDA; and Establishments may proceed to apply for medical device registration with MDA under the provisions of ACT 737. If both of the above requirements are met, MDA may consider the medical device registration application. Source: Medical Device Authority (MDA) Contact us at info@arqon.com for more information.

Medical Device Division (MDD) of Hong Kong introduced a new one-stop e-service platform for online application submissions for medical devices listing and traders under the Medical Device Administrative Control System (MDACS), safety alerts report submissions, and adverse events related to medical devices. MDD will cease any paper-based submissions after 14 October 2024. Therefore, the phase-out transition will commence on 2 April 2024 in stages outlined in the chart below. The transition process is conducted in phases to facilitate industries' adoption of the system during the transition period. Source: Medical Device Division (MDD) Contact us at info@arqon.com  for more information.

On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing Practices (B-GMP) Certificate from two (2) to four (4) years applicable to all medical device manufacturers under the Medical Device Single Audit Program (MDSAP). This enforcement enters into force on 1 April 2024 and it will only benefit the new certificates issued and any B-GMP certificate holders undergoing renewal requests waiting for ANVISA approval before enforcing the Resolution. Hence, those manufacturers with 2-year B-GMP certificate issuance will remain the same until the next renewal. Class III and IV medical device manufacturers were required to obtain a B-GMP certificate in Brazil. The certificate extension helps manufacturers reduce their regulatory fees and also enhances the benefits of the MDSAP certification. Source: National Health Surveillance Agency (ANVISA) Contact us at info@arqon.com for more information.

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 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.

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.

The Ministry of Health (MOH) of Singapore implementing the Implant Subsidy List effectively from 1 December 2023. The list consists of the implants fully registered with the Health Sciences Authority (HSA) and accessed by the Agency for Care Effectiveness (ACE) to be clinically- and cost-effective for specific clinical indications. Observation highlights a notable growth for the aging demographic, forecasting a surge in implant demand in the years ahead. Consequently, the government has commenced assessment for the first 15 out of 26 implant categories into the Implant Subsidy List. Subsequent categories will undergo phased assessment and integration into the list in the years ahead. As a result, automatic subsidy eligibility for implants will be discontinued. Here are the key takeaways from the briefing session: Horizon Scanning is a separate process from MedTech Evaluation, acting as an early Health Technology Assessment (HTA) process mainly to inform on resource planning. Submission of pipeline medical technologies through the Industry Notification exercise is encouraged to allow for: Provide early technologies visibility to MOH and may be used for early service planning or early adoption to the local public healthcare institutions. Potential horizon scanning assessment as adoption guidance To identify potential HTA topics Companies can submit new implant models via the Accelerated Pathway for expeditious Model Update Process (MUP) processing. MUP fee will be applied by the end of 2024 – Provide the best prices in the first instance for subsidy consideration. Return signed legal documents within stipulated timelines to avoid delays in subsidy listing Source: MOH ACE (Singapore) Contact us at info@arqon.com for more information.

The Health Sciences Authority (HSA) of Singapore was added to the Medical Device Division (MDD) acceptance list for marketing approval starting on 2 April 2024, joining South Korea (approved in 2023), Mainland China (approved in 2022), and GHTF 5 countries (US, Canada, Australia, EU, and Japan approved on 2004). HSA’s recognition is intended as medical devices compliance support for Hong Kong to the “Essential Principles of Safety and Performance of Medical Devices (Technical Reference: TR-004)”. With this new addition, several Guidance Notes (GN-02, 03, 04) and Application Forms (MD101, 102) are required for updates. Among the updates are modifications of the accepted Marketing Approvals scope, the addition of time for vetting and approving applications, and the replacement term of “Make” to “Manufacturer”. Application Form that was previously named “MD-C2&3&4” is renamed as “MD101”. Clause 3.2 & 5.1 in GN-04 were revised by acquiring manufacturers to ensure the medical device complies with the conformity assessment requirements of MDACS either through conformity assessment audits by CABs or an alternative route stated under Clause 5. The Local Responsible Person must be responsible for ensuring all MDACS requirements have been completed before submitting their listing application. The alternative route mentioned can be found under Clause 5.1 which the manufacturer may present the approvals from GHTF 5 members or Marketing Approvals from Mainland China, South Korea, or/and Singapore, as proof that the medical device conforms to the Essential Principles of Safety and Performance of Medical Devices (GN-01). Source: Medical Device Division (MDD) Contact us at info@arqon.com for more information.

The Circular, PSUR-13011(15)/1/2024-eoffice, was circulated by the Central Drugs Standard Control Organization (CDSCO) regarding the online submission of Periodic Safety Update Reports (PSUR) applications for medical devices or in-vitro devices marketing authorization. Starting from 01.04.2024, all PSUR application submissions must be submitted via the Online System for Medical Devices as per checklist and any offline, hard copy submission, or other mode will not be processed. As CDSCO progressively moves towards digitalization, this new mandatory requirement able to streamline the nation’s regulatory submission procedure and proves that India is poised to implement transparent and efficient regulatory compliance systems in line with global standards. Source: Central Drugs Standard Control Organization (CDSCO) Contact us at info@arqon.com for more information.

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.