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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 Hence, this circular effectivity automatically modified, repealed, and/or revoked the FDA Circular 2021-002-C. You may refer to our article about the previous regulatory flexibility extension here Source: Philippines Food and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.

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.

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.

Following the amendment for the Medical Mask (CNS 14774 (T5017)) and Disposable Dust Respirators (CNS 14755 (Z2125)) under the classification of I.4040 for Medical Apparel, Taiwan Food and Drug Administration (TFDA) revised the “Regulations Governing the Classification of Medical Devices” to align the regulatory requirements understanding for manufacturers or concerned applicants. Medical Mask, “D2 Class Medical Mask” stated under the above National Standards was replaced with “TN95 Medical Mask”. All medical masks with TN95 or N95 claimed, have to ensure the sub-micron particulate filtration and exhalation/inhalation resistance of airflow must be equivalent to the TN95’s performance requirements with the disposable dust respirators (CNS 14755 (Z2125)). Applicants for coloured or dyed medical mask registration are also required to submit evidence proving that their products comply with the quality requirements of CNS 14774, apart from test reports or certificates from competent authorities, qualified laboratories, or, international organizations as proof of claim that their products also complying the specific international or national standards. Source: Taiwan Food and Drug Administration (TFDA) Contact us at info@arqon.com for more information.

Effectively from 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released new process changes for the applications for marketing authorization for “Established Medicines” to assist the agency in assessing their applications efficiently and to provide smoother and shorter approval process timelines. The key changes implemented in the guidance are that MHRA will not process the incomplete applications and only one Request for Further Information (RFI) will be sent out to the agency. Besides, applicants are required to submit a template pre-populated with the Lay Summary for the UK Public Assessment Report (UKPAR) upon approval. MHRA provided 2 approaches for the applicants which are: Revised process for applications received but assessment has not started Revised process for applications under assessment or have received a “Request for Further Information”. Revised process for applications received but assessment has not started MHRA will notify the applicants two weeks before the assessment commences via email and applications are required to submit: Marked-up comparison of the Summary of Product Characteristics (SmPC) Text comparison between the Patient Information Leaflet (PIL) with the equivalent product information for the reference medicinal product Additional supportive generated stability data for the shelf-life period since the original submission and updated documents to reflect the data Revised process for applications under assessment or have received “Request for Further Information” MHRA will limit the applications to another final RFI, and MHRA will refer the application to the CHM if no response or incomplete response is received within the 60-day timeframe, for advice on refusal. The decision on approval or refusal will be made upon the assessment of the final RFI response. Following the assessment decision to approve, applicants are required to provide a template prepopulated with the Lay Summary for the UK Public Assessment Report (UKPAR) and MHRA will complete the UKPAR draft before published on the MHRA product website. Source: Medicines and Healthcare products Regulatory Agency (MHRA) Contact us at info@arqon.com for more information.

Health Sciences Authority issued a reminder about the final transition year for all medical device dealers to obtain confirmation from their designated Certification Bodies (CB) regarding the accreditation by the Singapore Accreditation Council (SAC). Effectively from 1 January 2025, dealers who wish to use ISO 13485 as their pre-requisite for medical device dealer license application are required to ensure their CBs are accredited by the SAC. Suppose the CB has not gotten accreditation before the dealers’ next cycle of recertification audit within the transition period (2022-2024), dealers are advised to check with the designated CBs on their plan to obtain SAC accreditation or consider changing CBs to the accredited CBs. Important to take note that HSA only accepts ISO 13485 certificated issued by the SAC accredited CBs or MDSAP certificates for medical device dealer license applications. Previously in 2021, HSA decided to implement the requirement of the SAC accreditation for CBs that issuing ISO13485 for medical device dealers to ensure the consistency and quality guaranteed throughout the certification process and the ISO13485 certification issued in line with the international medical device regulatory principles. Here is the link to the SAC-accredited CBs for Medical Device Quality Management System. Source: Health Sciences Authority (HSA) Contact us at info@arqon.com for more information.