2019 National Quality Inspection Plan Just Released: Pay Attention to Your Device Standards

New E-filing Requirement Posed for Legal Agent in China
May 22, 2019
Two Milestones at IMDRF Meeting: Bringing China Closer to International PMS and Clinical Standards
October 8, 2019

2019 National Quality Inspection Plan Just Released: Pay Attention to Your Device Standards

NMPA (CFDA) announced “2019 National Quality Inspection Plan for Medical Devices”. The Plan asks provincial NMPA offices and type testing centers to conduct quality inspections based on Industry Standards and Product Technical Requirements (PTRs).

The plan covers 54 medical devices and IVDs:

  • Orthopedic

acetabular cup, hip femoral head, acetabular lining, metal plate, etc.;

  • Imaging

digital photography X-ray machines, mobile X-ray machines, Electrocardiograph, etc.;

  • Hematology

hemodialyzer, single use blood perfusion devices, hemodialysis concentrates, etc.;

  • Dental

custom fixed denture, ultrasonic cleaning equipment, etc.;

  • Gastroenterology and Urology

disposable sterile urinary catheter, radiofrequency ablation catheter, etc.;

  • Ophthalmic

soft contact lens, contact lens care solution, viscoelastic, etc.;

  • IVD

Thalassemia gene detection Kit, Ketamine detection kit, Hepatitis B virus surface antigen detection kit, Treponema pallidum antibody detection kit, Cystatin C assay reagent, Human chorionic gonadotropin test strip, etc.;

The Plan also lists institutions and procedures for inspecting, retesting and appealing.

For an English copy of “2019 National Inspection Plan for Medical Devices”, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Implications of New Standards

NMPA (CFDA) issued the “2019 Medical Device Industry Standards Revision Plan” on March 20, in which 93 medical devices, IVDs are affected. Revision of more than 300 industry could be expected by the end of 2020, as NMPA announced in February 2018.

Whether you are renewing or submitting new registration, your medical devices need to meet new industry standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards. ChinaMed Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.

To determine your applicable Industry Standards, please email info@ChinaMedDevice.com.

For our comments on 2019 Standards Revision Plan, please click HERE.

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

About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in 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.e