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HSA | Guidance documents for clinical trials

    https://www.hsa.gov.sg/clinical-trials/regulatory-guidances
    Medical devices; Therapeutic products; Health supplements; Traditional medicines; Chinese proprietary medicines; Cosmetic products; Tobacco regulation; CTGTP; More Regulations. Clinical trials Controlled drugs and psychotropic substances; …

Import of Clinical Trial Materials (CTM) GST Relief …

    https://www.hsa.gov.sg/announcements/regulatory-updates/import-of-clinical-trial-materials-(ctm)-gst-relief-arrangements-(effective-from-october-2011)
    Medical devices; Therapeutic products; Health supplements; Traditional medicines; Chinese proprietary medicines; Cosmetic products; Tobacco regulation; CTGTP; More …

HSA | Guidance documents for medical devices

    https://www.hsa.gov.sg/medical-devices/guidance-documents
    HSA | Guidance documents for medical devices Home Medical devices Guidance documents for medical devices Here is the list of guidance documents with …

HSA | CTA, CTN or CTC submissions

    https://www.hsa.gov.sg/clinical-trials/application
    Medical devices; Therapeutic products; Health supplements; Traditional medicines; Chinese proprietary medicines; Cosmetic products; Tobacco regulation; …

HSA | Medical devices

    https://www.hsa.gov.sg/medical-devices
    Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to: Diagnose, alleviate or treat a medical …

HSA | Regulatory overview of medical devices

    https://www.hsa.gov.sg/medical-devices/regulatory-overview
    We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. All medical devices will require registration with us before …

Importing Medicinal Products and Therapeutic Products …

    https://www.customs.gov.sg/businesses/importing-goods/import-procedures/importing-medical-products-and-therapeutic-products-for-clinical-trials
    The import of the following clinical trial test materials (CTMs) into Singapore is granted Goods and Services Tax (GST) relief pursuant to item 40, 41 and 42 of the Schedule to …

HSA | New Clinical Trial Authorisation (CTA) or Clinical …

    https://www.hsa.gov.sg/clinical-trials/application/apply-cta-ctn
    A CTA or CTN is required prior to the initiation of a clinical trial of a therapeutic product, or a Class 2 cell, tissue and gene therapy product (CTGTP). A CTA is required for …

HSA | Submit a Clinical Research Materials notification

    https://www.hsa.gov.sg/clinical-trials/crm-notification
    If you are an importer of Clinical Research Material (CRM), you will need to submit a CRM notification before importing the CRM, unless the CRM is locally-registered and you are …

Complaints Tracking Module (CTM) - HHS.gov

    https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/ctmfaq_01.10.06_1.pdf
    The Complaints Tracking Module (CTM) is a module within the Health Plan Management System (HPMS). It is the Centers for Medicare and Medicaid Services’ (CMS) central …



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