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Two Imported Devices Obtain NMPA Innovation Approval

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The NMPA granted Innovation Approvals to two overseas manufacturers in August 2022:

What are the Devices

The NMPA released the review reports for the two devices below. Email info@ChinaMeddevice.com to get a copy. We also offer translation service for nominal fees

Oxidized Regenerated Cellulose (ORC) powder

The product consists of Model 3013SP regenerative oxidized cellulose absorbable hemostatic granules (pre-assembled containing device) and Model 3123SPEA regenerative oxidized cellulose absorbable hemostatic granules endoscopic administration catheter device.

Both are radiation sterilized for single use. Model 3013SP is an application device pre-assembled with 3g of hemostatic granules made of fine fiber compacted by a patented process for open surgery; Model 3123SPEA, can be used with 3013SP for endoscopic surgery.

The product is suitable for surgical or endoscopic surgery (except ophthalmology, neurosurgery, urology), and is used as an aid in the control of bleeding from capillaries, venules, and arterioles when ligation or other traditional control methods are not applicable or ineffective.

The product is the first granular regenerated oxidized cellulose hemostasis product, its particles are made of patented process compaction of fine fibers, and its matching powder application device can make the instrument face without affecting the effective and uniform spray of particles, which is convenient for surgical or endoscopic surgery.

Meningitis/Encephalitis (ME) detection panel

The product consists of test strip, sample buffer, lysate, disposable red sample syringe, and individually packaged pipettes. The product is a disposable closed detection reagent for the qualitative detection of nucleic acids of 14 bacteria, viruses and cryptococci in cerebrospinal fluid (CSF) samples in people with meningitis and/or encephalitis signs and/or symptoms in vitro.

The product adopts closed nest multi-PCR melting curve method, based on multi-nest PCR amplification, and melting curve analysis technology, to detect and analyze the samples after mechanical grinding and crushing. Multiple-nest PCR amplification combined with melting curve analysis improves the sensitivity and specificity of the detection kit, and the system software automatically evaluates the data and reports the results.

The product detects and identifies 14 potential central nervous system infection-related pathogens in CSF, and the test results can be obtained in about 1 hour, which accelerates the pathogenic diagnosis of meningitis of encephalitis, so that targeted clinical treatment can be carried out as soon as possible, reducing the burden on patients caused by diseases such as meningitis.

Key Takeaways for Overseas Manufacturers

Overseas manufacturers need to bear in mind that:

  1. The NMPA gives overseas manufacturers equal opportunity for the fast-track channels. No difference as to the qualifications for domestic manufacturers vs. overseas ones
  2. “Conditional Approval” applies for urgently needed medical devices. NMPA issue the “Guideline on Conditional Approval for Medical Devices” on December 20, 2019. It specifies that devices and IVDs indicated for life-threatening illnesses can be granted “Conditional Approval”, if the benefits of the products overweigh the risks, and the manufacturers are committed to do further clinical research
  3. They can initiate innovation approval applications at same time when applying China Patent & Trade Office coverage. Application does not have to be made after getting the patent
  4. Having been granted “status” does not mean “approval”. With ‘front-of-queue’ priority, they still need to go through the normal review process.

China Med Device has translated “Innovation Approval Procedure for Medical Devices” and other official NMPA documents into English as a service for its clients. Email info@ChinaMedDevice.com for details.

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