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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.

Generally, companies that intend to manufacture and/or distribute medicinal, transplant, gene therapy products, or genetically modified products in Switzerland are required to obtain an establishment license from Swissmedic. There are eligibility requirements that must be complied with by the companies. There are three (3) types of application submission procedures related to the establishment license: Procedure for Initial Issue of the Establishment License, Procedure for Changes Application to the Establishment License, and Procedure for Discontinuation Application of the Establishment License. On 9 January 2024, Swissmedic announced the additional form required “Application for Establishment License – Discontinuation of the Establishment License Medicinal Products (incl. blood)” to be submitted during the discontinuation application together with the “Application for Establishment License – Basic Form Medicinal Products (incl. blood)”, basic form, and supplementary documentation. Companies must ensure all the criteria stated in the form have been resolved properly with guaranteed quality and safety of the medicinal products in the market before the decision to discontinue the establishment license can be issued. Supplementary documentation needed is related to medicinal products or TpP/GT/GMO, change of name, and Responsible Person multiple mandates. The authorized signatory or Responsible Person must sign all documentation. Source: Swissmedic Contact us at info@arqon.com for more information.

The Health Sciences Authority (HSA) recently revised the guidance of the medical device product registration (GN-15) under Revision 10 and effectively can be referred to as guidance starting from 24 January 2024. HSA revised the marketed period for medical devices that will undergo the selected evaluation routes: Immediate Class B Registration (IBR) Evaluation Route Expedited Class C Registration (ECR) Evaluation Route Medical devices under these 2 routes are required for a minimum of three (3) years marketed in the reference regulatory agencies’ jurisdiction. Otherwise, medical devices listed under Class B and C applications to go through these routes will be rejected. ** Reference Regulatory Agencies: Health Canada, US FDA, Therapeutic Goods Administration (TGA), Japan Ministry of Health, Labour, and Welfare (MHLW), European Union Notified Bodies (EU/NB), and others All medical devices including in-vitro medical devices (IVD) are compulsory to be registered under HSA unless exempted, for instance, Class A medical devices. For Class B, C, and D, HSA prepared evaluation routes to facilitate the registration of medical devices. Each evaluation route listed has its eligibility criteria and applicants must ensure the medical devices are complying with the requirements before submitting applications. Also, it is important to note that the immediate, expedited, and abridged evaluation routes are only applicable to those medical devices that have been evaluated and obtained marketing approvals from, at least one of the Global Harmonization Task Force (GHTF) (Australia, Canada, European Union, Japan, and USA). Source: Health Science Authority (HSA) Contact us at info@arqon.com for more information.

Effectively starting from 10 January 2024, all initial applications for Certificate of Medical Device Registration (CMDR) and renewal applications for Certificate of Medical Device Notification (CMDN)/CMDR shall be entitled to “one-time compliance” for submission of the deficiencies requested during the application review. Disapproval applications may occur if the requested documents are not submitted within the provided timeframe. The FDA of the Philippines allows for the re-application or full compliance to be made for disapproved applications within the specific period, upon the date of the disapproval. Initial Application: Sixty (60) days Renewal Application: Thirty (30) days Applicants shall include a copy of the Notice of Deficiency (NOD) and documents requested in the NOD. Besides, a corresponding fee will also be charged and a new Document Tracking Number (DTN) will be assigned for the re-application procedure. Applicants are advised to use the old application DTN in the re-application email to the FDA for new DTN issuance. The new DTN will be used for the re-application fee payment. Source: Food and Drug Administration of the Philippines (FDA) Contact us at info@arqon.com for more information.

The Central Drugs Standard Control Organization (CDSCO) released a circular of the regulatory guidelines for the sampling procedure of the drugs, cosmetics, and medical devices and consolidated monthly records of the Not of Standard Quality (NSQ) or Spurious drugs to be published on the CDSCO website. A few key factors were lined up in the guidelines to guide drug inspectors during the sampling: Sampling Plan, Selection of Samples, Selection of the Sampling Location, Number of Samples, Quantity of Samples, Timelines, Database/Monitoring, Testing Laboratories Sampling Plan Drug Inspectors are advised to prepare sampling plans on monthly basis with the consultation of the controlling authority and prepare finalized sampling locations annually. All rural, tribal areas and drugs to be used in the endemic areas for certain diseases and seasonal diseases must be included in the sampling plan. Selection of Samples Drug Inspectors should identify various factors that may indicate the possible higher risk that may affect the drug quality. Suggested guidance is to draw samples from different therapeutic categories, different formulations, and different manufacturers. Samples collected are limited to max 3 samples and records and approval shall be acquired upon excess samples. Drug Inspectors must ensure at least all the identified risks listed in the guidance are utilized in the sampling for 6 months. Number of Samples Samples to be collected are at least 10 samples in a month, which include 9 samples of drugs and 1 sample of cosmetics or medical devices. Timelines Collected samples must be delivered to the laboratory on the same day or not more than the next day. Name, address, and copy of the invoice shall be extracted from the drug or cosmetic owners for any possibility of Spurious drug. For patent drugs or new drugs, Drug Inspectors shall extract the method of analysis and reference/working standards from the manufacturers of the sample. Before, sampling was limited to the individual knowledge of the drug inspector and challenges were identified concerning the limitation of product selection and the location of the sampling. Hence, evaluations were overlooked impacting patients’ access to good quality products. Sampling is important to ensure the quality of the products available in the market is safe for patients to use. The generated data from the sampling activity can assist manufacturers and authorities in planning strategies to achieve continuous availability of guaranteed good quality products in the market. Source: Central Drugs Standard Control Organization (CDSCO) Contact us at info@arqon.com for more information.

On the 30th January 2024, the Environmental Protection Authority (EPA) decided to eliminate Per/Poly- fluoroalkyl substances (PFAS) in cosmetic products, as part of a precautionary approach to any potential risks that could be emitted from the chemicals. PFAS also dubbed as ‘forever chemicals’ consists of a group of thousands of synthetic chemicals, characterized by multiple carbon-fluorine bonds. PFAS can be found in cosmetic products such as nail polish, foundation, lipstick, and mascara. The ingredients are designed to smoothen the skin and maintain the product’s durability and water-resistance characteristics. However, the chemicals may contain toxins at high levels and do not easily break down in the human body, which is also suggested by international research for PFAS to only be found in a small number of products. On January 2023, The European Chemicals Agency (ECHA) published a proposal on the PFAS restriction in various products including cosmetics aiming to reduce toxic emissions and provide safer life quality for the community. Hence, the EPA decided to list PFAS under prohibited substances in Schedule 4 with a transitional period up to 31 December 2026. Manufacturers, distributors, or responsible persons may continue to import or manufacture cosmetic products with PFAS as ingredients until 31 December 2026 and to supply the cosmetic products with PFAS ingredients until 31 December 2027. Amendments to Cosmetic Products Group Standard In 2023, The Environmental Protection Authority (EPA) made 26 proposals to amend and update the Group Standard including: Rules alignment for ingredients with the European Union requirements which can be found in Schedules 4 to 8 of the group standard (banned, restricted, subjected to other rules) The ban on PFAS ingredients Consolidating Schedules 4 to 8 under one document Updating the requirements of fragrances Widening the scope to include non-hazardous products Implement 24-hour emergency contact label exemption Hence, on the 25th of January 2024, the EPA released the decision on the approved amendments/updates that have been finalized by the Committee after considering the comments from the participants and the Ministry of Health. Approval of the banning of PFAS ingredients in cosmetic products Approval to increase the scope of the Group Standard to include the non-hazardous cosmetic products that contain hazardous substances Approval to amend the label exemptions (24-hour emergency contact) and adding the United Kingdom to the Alternative International Regulators List Updated the record-keeping requirements for nanomaterials Updated Schedules 4 to 8 of the Group Standard to include substances listed in European Union Cosmetic Regulation (EC 1223/2009) except for ingredient Zinc Pyrithione Source: Environmental Protection Authority (EPA) Contact us at info@arqon.com for more information.

On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the appointment of 2 new Approved Bodies, LNE-GMED UK and Scarlet NB UK. The appointment of the new Approved Bodies to widen the capacity for certifying the performance and safety of medical devices, as the existing 2 Approved Bodies, UL International UK is extending its scope for general medical devices assessment and certification. While TÜV SÜD scope has been broadened for active implantable medical devices assessment and certification. LNE-GMED UK is responsible for assessing and certifying general medical devices and Scarlet NB UK will be focusing on assessing and certifying software and AI as a medical device. This designation is expected to align with Part II of the UK Medical Devices Regulations 2002. The expansion of the Approved Bodies is to support the industry demand from the manufacturers to enter the UK market and ensure patients gain access to high-quality and safe medical products. Source: Medicines and Healthcare products Regulatory Authority (MHRA) Contact us at info@arqon.com for more information.

On the 2nd January 2024, the Device Review Centre of the State Food and Drug Administration released the notice on the revision for 12 registration review guidelines and research registration review guidelines for the main raw ingredients of in vitro diagnostic reagents. The main objective of the revision is to provide structural guidance for formulating the in vitro diagnostic reagents and technical reference for regulatory authorities during the review. The revised guidelines consist of documents and guidance that can assist regulatory affairs professionals in preparing the registration, filing, and management of the in vitro diagnostic reagents including the approval certificates. There are many pivot keys focussed in the guidelines: Main information: reagent components description, quantities, names, materials used, quantities, and many more Product name: product naming principles Packing specifications: number of samples, number of samples, samples for testing Intended use: type of tests (qualitative, quantitative), types of samples Test method: details instructions for reagent preparation, sample processing, calibration, and result interpretation Warning & Precautions: mention the limitation, after effects, or warnings for the in vitro use and substances consisting of human or animal origin in the products Manufacturers are allowed to alter the guidance according to the characteristics and intended use of the products due to the diverse nature of in vitro reagents with varying clinical use and methodologies. Hence, manufacturers can deliver accurate information about the products to patients or users. The guidelines will be reviewed from time to time to ensure the data accuracy and adaptability to the current trends. Source: Centre of Medical Device Evaluation (CMDE) Contact us at info@arqon.com for more information.

The Medical Device Authority (MDA) released guidance for the importation of personal use medical devices and the guidance is applied to all home-use medical devices that fall under the definition as defined in MDA/GD/0006. As generally informed, medical device importation must undergo legal registration and comply with the requirements of MOH before being able to enter the Malaysian market. However, the exemption is granted under Medical Device (Exemption) Order 2016 for medical device registration and establishment license requirements for personal use of medical devices. The exempted personal use medical devices cover all importation modes either by land, sea, or air. For those personal use medical devices to be placed in the market, it does not include the usage of clinical research or for performance evaluation of the medical devices. All medical devices for personal use that is imported or purchased (including online purchase) may be exempted from the requirement for medical device registration under Section 5 of Act 737 and establishment license under Section 15 of Act 737, if fulfilled the following requirements: The medical device is applicable only for home use The medical device is owned only for own or immediate family use The medical device’s labeling information should be retained The quantity of medical devices to own shall be appropriate according to the type of medical devices There are similar or the same medical device types registered in Malaysia Acquire formal prescription or letter of recommendation on the medical devices from the registered healthcare professional, upon requests from the Authority The medical devices are not specified under professional use medical devices (stethoscope etc) The medical devices are not authorized under MOH to be handled by professionals only (injectable dermal filler etc) Source: Medical Device Authority (MDA) Contact us at info@arqon.com for more information.