Overseas Companies Qualify for Innovation Approval, while All Approved are Domestic

The Implied Approval of Clinical Trial for Medical Device Takes Effect on April 1, 2019
April 5, 2019
Monthly NMPA News Roundup (March 2019)
April 10, 2019

Overseas Companies Qualify for Innovation Approval, while All Approved are Domestic

In January 2019 NMPA published Catalog of Innovation Approvals, in which 54 medical devices and IVDs are approved, and 197 medical products are under review. The 54 approved include 22 implantable devices, nine diagnostic devices, and 13 IVDs; all approvals are granted to domestic companies.

Strict Procedures

NMPA received 316 Innovation Device Applications in 2018, in which 45 applications, or 14%, were qualified and went into next phase, NMPA’s review. If the designated Innovation Device passed the review, it will be allocated ‘front-of-queue’ priority throughout the registration process. Over the years, although overseas manufacturers are qualified for Innovation Approval, and they have many devices under review, none of them have gotten the registration approval.

ChinaMed Device, LLC is experienced in handling innovation approval and priority review. Our latest success was Innovation Approval of CT-Linac, manufactured by United Imaging (see the link HERE). Also, we are an NMPA certified legal agent. We can represent you without your need to set up legal entity or local offices in China.

Five Criteria

NMPA issued the final version of Innovation Approvals Procedure on November 5, 2018. It provides five criteria to qualify for the special review and approval procedure:

  1. Class II / Class III Medical Device with significant clinical application value,
  2. Own valid invention patents,
  3. Have China PTO coverage,
  4. Complete the preliminary study on prototype with traceable data, and
  5. An authorized in-country legal entity.

If you have any questions on the above criteria, please email us at info@ChinaMedDevice.com.

First Innovation Device in 2019

On March 20, 2019, NMPA granted Innovation Approval to abdominal endovascular stent graft, manufactured by MicroPort, a Shanghai based company. It is the first Innovation Approval granted this year.

The approval notice states “a CUFF stent graft can be placed at the proximal end of the stent graft or a branch stent graft can be placed at the distal end of the stent graft stent as an extension”, and, in terms of the delivery system, “the ultra-fine outer diameter enables the stent system to easily reach the lesion through sharply curved blood vessels”

 

For English version of Innovation Approvals Procedure, 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 market access newsletter, click HERE. For CRO services in China, click HERE.

 

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.