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Clinical Trials Guidance for Singapore  

MedicinesMedical Devices | Singapore

The key objectives of the CRM regulations include the following:

  • Facilitate access to CRM
  • To require imported or locally-manufactured CRM to be of sufficient quality
  • To restrict the supply of imported or locally-manufactured CRM to regulated clinical trials or IRB-approved clinical research
  • To require traceability and accountability of CRM through record-keeping
  • To require appropriate CRM labelling
  • To require reporting of unexpected serious adverse drug reactions (USADRs), or medical device adverse events related to the use of CRM
  • To require disposal/export of imported or locally-manufactured CRM after
    the research/trial ends
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Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions  

Medical Devices | United States of America

You should provide the following information for your device:
• A description of the overall device system;
• A labeled diagram and the specifications for each model included in the submission, e.g., lengths, inner and outer diameters;
• Functionality, including specifications (if applicable) of the individual components of the tubing system, e.g., heparin lines, infusion ports, drip chambers, infusion lines, priming sets, transducer protectors; and
• A description, such as might be found in labeling, of the hemodialysis delivery systems legally marketed in the United States that are compatible with the blood tubing set.

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Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process  

Medical Devices | United States of America

This guidance provides the criteria for industry and Food and Drug Administration (FDA) staff to use in determining the type of PMA submission (i.e., traditional PMAs, panel track supplements, 180-day supplements, real-time supplements, Special PMA Supplements-Changes Being Effected, 30-day notices, manufacturing site change supplements, or periodic reports) that you should submit to FDA when you modify the design or labeling of your PMA device; its manufacturing process; or the location of manufacturing, processing, or packaging. The guidance also provides examples of various types of device modifications, describes the types of testing that were performed to support the safety and effectiveness for each device modification, and the type of PMA submission that was submitted. It does not address how to test a specific device to determine the effects of modifications.

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E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS  

Medical Devices | Singapore

Product registration applications for medical devices are submitted online to HSA and may be compiled and prepared from the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) In Vitro Diagnostic Device Market Authorization Table of Contents (IVD MA ToC).

Applications must be submitted online to HSA via MEDICS. The technical dossier and supporting
documents shall be submitted in softcopy in MEDICS.

This document applies to in vitro diagnostic medical devices only.

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E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS  

Medical Devices | Singapore

Product registration applications for medical devices are submitted online to HSA and maybe
compiled and prepared from the ASEAN Common Submission Dossier Template (CSDT) or the
International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Medical Device
Market Authorization Table of Contents (nIVD MA ToC) from the medical device manufacturer.
Applications must be submitted online to HSA via MEDICS. The technical dossier and supporting
documents shall be submitted in softcopy in MEDICS.

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Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices  

Medical Devices | United States of America

Antibacterial susceptibility testing is used to determine if bacteria that are isolated from a patient with an infection are likely to be killed or inhibited by a particular antibacterial drug product at the concentrations of the drug that are attainable at the site of infection using the dosing regimen(s) indicated in the drug product’s labeling. The results from antibacterial susceptibility testing generally categorize bacteria as “susceptible,” “intermediate,” or “resistant” to each antibacterial drug tested.5 When available, culture and susceptibility testing results are one of the factors that physicians consider when selecting an antimicrobial drug product for treating a patient.

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Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach  

Medical Devices | Singapore

Software plays an increasingly important role in medical devices as a myriad of medical devices rely
on software for safe and effective function, as well as for interoperability with other devices. In addition, emerging technologies like Artificial Intelligence and the Internet of Things (IOT) are being increasingly adopted for clinical applications, which introduces new and complex challenges (e.g. cybersecurity) to manufacturers who are developing medical device software.

To address this, all software medical device manufacturers are recommended to adopt a Total Product
Life Cycle (TPLC) approach to manage and adapt to rapid changes. This will include requirement
management, risk assessment, software verification and validation, change management, traceability,
and various aspects throughout a software’s life cycle.

This guideline describes the following points;

  • Quality Management System (QMS) For Software Medical Devices
  • Pre-Market Product Registration Requirements
  • Software Manufacturers And Distributors: Activity Controls
  • Changes To A Registered Software: Change Notification
  • Post-Market Management Of Software Medical Devices

 

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