Overseas Inspection Results in Jan: Big Players Cited

ChinaMed Device Cited by RAPS on Overseas Inspection
February 8, 2019
CFDA Monthly Roundup (January)
February 15, 2019

Overseas Inspection Results in Jan: Big Players Cited

NMPA (CFDA) published two groups of overseas inspection results on Jan 18 and Jan 30. 17 overseas medical device and IVD manufacturers were cited, including some big players, BD, Boston Scientific, Varian, Deerfield Imaging, etc. Manufacturing facilities were located in the U.S, UK, Germany, Netherlands, France, Japan, South Korea.

 

  1. BD (U.S): Vacuum blood collection tube
  2. Boston Scientific (U.S): Implantable pacemaker, automated external defibrillators (AED)
  3. Rayner Intraocular Lenses (U.S.): Acrylic intraocular lens
  4. Varian (U.S): Linear Accelerator (LINAC)
  5. Deerfield Imaging (U.S): Magnetic resonance imaging (MRI) equipment
  6. Ophtec (Netherlands): Posterior chamber intraocular lens; Capsular tension ring
  7. Hermannswerder (Germany): Circulating epithelial cell (CEC) sampling needle
  8. Waldemar Link (UK): Hip prosthesis
  9. HumanOptics AG (Germany): Acrylic intraocular lens
  10. Sophysa (France): Cerebrospinal Fluid (CSF) Drainage Systems
  11. Air Liquide (France): Ventilator
  12. Fujirebio (Japan): Mycoplasma pneumoniae antibody detection kit, Treponema pallidum antibody detection kit
  13. Merz (U.S): Microcrystalline apatite soft tissue injection filler
  14. Sysmex (Japan): HIV antigen antibody detection kit
  15. Osstem Implant (Korea): Pure titanium dental implant
  16. Dentium (Korea): Dental implant
  17. BraunAvitum (Germany): High-throughput polysulfone membrane dialyzer

 

For NMPA link of detailed results with observations and penalties, please email info@ChinaMedDevice.com. ChinaMed Device, LLC, a NMPA certified legal agent, can help you prepare NMPA overseas inspection with onsite training.

 

From November 2017 to February 2018, 24 foreign manufacturers have been found with issues in overseas inspections. The significant issues disclosed by the overseas inspections include internal packaging breakage, incomplete supplier information, improper handling of adverse events, airborne dust particles exceeding the standard, deficiencies in disinfection effecting verification, raw materials mixing, testing standards mismanagement, lack of operating procedures, air filter supplier audits, etc.

 

On December 28, 2018, NMPA issued Guideline on Overseas Inspection for Drugs and Medical Devices. This new regulation clarifies overseas inspection process and responsibilities of NMPA (CFDA) and overseas manufacturers. It also specifies that overseas inspection includes not only manufacturing sites, but also overseas R&D locations.

 

For RAPS post on NMPA overseas inspections, please see link Here.

For English version of Guideline on Overseas Inspection, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in. For CRO services in China, click HERE.

 

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.