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Medtronic and Siemens caught from NMPA (CFDA) clinical trial inspection

  • 1.  Medtronic and Siemens caught from NMPA (CFDA) clinical trial inspection

    Posted 19-Dec-2018 18:14

    In order to strengthen the management of medical devices clinical trials, NMPA (CFDA) launched the Notice of First Batch Medical Device Clinical Trial Inspection Results in 2018. Through on-site inspection, 9 clinical trials were found to have the following compliance issues:

    1.   Siemens: Thyroid stimulating hormone receptor antibody assay kit

    • The rules on blinding and unblinding in the operating procedures established by clinical trial sites are inconsistent with the related content in clinical trial protocols.
    • 10 subjects had a pre-treatment diagnosis but there wasn't previous medical record provided.
    • 12 subjects had neither pre-treatment diagnosis nor previous medical records.

     

    2.   Medtronic: Drug-coated peripheral balloon dilatation catheter

    • The central site did not analyze the results of imaging examinations with poor efficacy, and there was no reasonable excuse.
    • The main efficacy indicators in the test manual were inconsistent with the actual calculation formula.

     

    3.   Shangxian Minimal Invasive Inc.: Capsule endoscope system:

    • The use time of product wasn't recorded in product registration form
    • The clinical trial site didn't provide transportation, storage conditions and distribution records of the test product.
    • The case report form is modified, but there is no sign for confirmation.

    4.   Percutek Therapeutics: Thoracic aorta stent graft system:

    • The main efficacy evaluation of some subjects was not performed based on the clinical trial protocol;
    • In some cases, the data in the case report form are incomplete;
    • In statistical report, some combined medications in some subjects' case report form were not recorded.

    5.   Beijing Datsing Bio-Tech: Absorbable hemostatic membrane

    • Test product use record is not shown on some subjects' inpatient medical records and surgical records.
    • Some subjects did not meet the inclusion criteria.
    • Adverse events of some subjects are not recorded.
    • The clinical trial site didn't provide training records for some clinical trial researchers.

    6.   Koncen: Single-use bilirubin adsorption column

    • The ethical approvals did not clarify the version number of the clinical trial protocol and informed consent.
    • The family signed the informed consent without reasonable reason.
    • The deviation from the clinical trial protocol was not recorded.
    • Some adverse events are not recorded.

    7.   Zhejiang Shundi: Single use of drug-containing cervical dilatation rod

    • Some subjects were taken outpatient surgeries, but there were no surgical records saved.
    • The original records of the test product indwelling time in the cervix are not found in the clinical trial report.
    • The test product names are inconsistent in some records.

    8.   Nanjing Haotai Microwave: Multi-frequency microwave acupuncture physiotherapy

    • The informed consent form lacked risk notification related content.
    • The clinical trial site didn't provide the use and management records of the product and the subject treatment record card.
    • The clinical trial protocol saved by the clinical trial site was unsealed.

    9.   Shandong Qiyu: Medical electron linear accelerator of SPACO

    • The clinical trial report didn't record serious adverse events unrelated to the test product.
    • Some subjects didn't take the pathological diagnosis, it didn't meet the requirements of clinical trial protocol.

     

    Comments from NMPA (CFDA)

    1. For the above 9 registration projects, the NMPA will conduct a comprehensive analysis based on the registration application materials and the clinical trial inspection, evaluate and review in accordance with relevant regulations.
    2. The clinical trial sponsors, clinical trial sites and researchers should strengthen the study and implementation of the "Quality Management Standards for Clinical Instruments Clinical Trials" to ensure the scientific and standardized clinical trial process and true and reliable results.
    3. All provincial regulatory authorities should pay more attention to this situation, take effective measures to strengthen the administration of medical devices clinical trials within their regions.

    For list of 47 clinical sites (hospitals), please email info@ChinaMedDevice.com.

    For webinar on clinical trial & CER in China, please click HERE.

    Keep yourself updated with CFDA News Roundup, click HERE to opt-in.

     

    About ChinaMed Device, LLC 

    ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.

     



    ------------------------------
    Grace Fu Palma
    China Med Device, LLC
    MA, U.S.
    gpalma@chinameddevice.com
    978-390-4453
    www.chinameddevice.com
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