NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” today (February 25), in which 86 medical devices, IVDs and documentation methods are included. The Guidelines Revisions are aimed to facilitate manufacturers with product registration and make the guidelines more consistent with the international guidelines. The Plan also states that “NMPA calls for related manufacturers, industry associations and research institutions to contribute their opinions to the guidelines revisions”.
Whether you are renewing or submitting new registration, your medical devices and guidelines need to meet these new guidelines. 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 guidelines. 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 guidelines. 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. info@ChinaMedDevice.com.
The plan includes following areas:
Endoscopy electrosurgical unit, endoscopy for gastrointestinal tract, X-ray computed tomography (CT) system, artificial intelligence (AI)-aided medical device, non-invasive transcutaneous pacing, implantable and non-implantable magnetic resonance device, dental digital impression instrument, home-use pulse oximeter, etc.
Bioresorbable polymer drug-eluting coronary stent, balloon dilatation catheter, knee replacement, dura mater patch, Intraocular lens, orthokeratology corneal reshaping lens, metal intramedullary nail, firm embryo transfer catheter for assisted reproduction, fallopian tube catheter, facial prosthesis, etc.
Hepatitis B virus E antigen and E antibody detection reagent, Thalassemia gene detection reagent, Dengue virus nucleic acid detection reagent, EB virus nucleic acid detection reagent, Rheumatoid factor (Rf) detection reagent, home-use IVD, etc.
Prior approval supplements guideline, guideline on digital submission of registration documents (draft).
It is worth noting that the Plan includes five 3D printed devices: 3D printed spine fusion cage, acetabular cup, spinal implants, bone implants and mandible. NMPA published general version of 3D Printed Medical Device Guideline in February 2018.
Revision of more than 300 industry standards for medical devices, IVDs and quality systems could be expected by the end of 2020, as announced by the NMPA in January 2018.
For NMPA link of the 2019 Medical Device Registration Guidelines Revision Plan, please email info@ChinaMedDevice.com.
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.