Siemens, Medtronic Found Incompliance in CFDA Clinical AuditOctober 14, 2018
In order to strengthen the management of medical devices clinical trials, the National Medical Products Administration(NMPA, formally 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:
Capsule endoscope system of Shangxian Minimal Invasive Inc.:
- 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.
Thoracic aorta stent graft system of Percutek Therapeutics:
- 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.
Absorbable hemostatic membrane of Beijing Datsing Bio-Tech Co., Ltd
- 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.
Single-use bilirubin adsorption column of Koncen
- 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.
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.
Multi-frequency microwave acupuncture physiotherapy of Nanjing Haotai Microwave Technology Co., Ltd.
- 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.
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.
Drug-coated peripheral balloon dilatation catheter of Medtronic, Inc.
- 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.
Thyroid stimulating hormone receptor antibody assay kit (chemiluminescence method) of Siemens Healthcare Diagnostics Products Limited:
- 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.
Comments and related requirements
- 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.
- 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.
- 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 more information about avoiding compliance issues in clinical trials in China, please email info@ChinaMedDevice.com.
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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.