NMPA First Approved ENT Active Implant With Real World Data

BradyKnows provides the turnkey regulatory and clinical solutions to NMPA first approved ENT active implant with real world data. It is following Hainan urgent use policy to collect real world data integrated into clinical evaluation report (CER) for NMPA approval. BradyKnows services to this client cover the strategy, registration, type testing, clinical study, clinical evaluation report writing, post-market surveillance, new product R&D etc. for all product pipelines since 2015.

Brady Service Description

Time

Brady Resource

Note

Strategy map-out and refreshing

Oct, 2020

Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
PM * 1

* Refresh the strategy corresponding to the upgrade of regulations and policies.
*Assess the benefit and risk of new policies.

Type testing

Fixture preparation

Mar, 2021

RA * 2
RA Director * 1
Technical Director * 2

As per the actual situation, adjust and prepare the fixtures.

Type testing technical meetings

Oct, 2020-April, 2021

Discuss the test protocol.

Hospital MR safety test

April, 2021

MRI test environment setting up.

Clinical Evaluation Report writing and revision

Nov, 2020-July, 2021

Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
MA * 2
RA * 2
PM * 1

*Analyze the predicates and the products from competitors.
*Search literatures.
*Search related surgery data.

Surgeon survey

Mar, 2021

CRC * 2
CRA * 2
Clinical Director * 1
Clinical VP * 1
PM * 1

Collect and compile the intra-operative and post-operative safety data, including complications.

Hainan Real World Study

RWS pathway assessment

June, 2020

Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
PM * 1

*Analyze China’s new RWS guideline * Assess the benefit and risk of RWS pathway

Data collection plan and protocol

June, 2020

Clinical Director * 1
Clinical VP * 1
Technical Director * 2
RA Director * 1
MA * 2
PM * 1

Analyze the related product guidelines, NMPA clinical guidelines and overseas clinical data to prepare protocol

RWD Application Pilot Program
(Fast Track pathway)

July, 2020

RA * 2
Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
PM * 1

*Collect product dossiers to prepare Fast Track documents
*Include RWS protocol, CER, and innovation documents etc.

Pilot Program Expert Panel Meeting

Oct, 2020

Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1

 *Competing with other 80+ medical devices
* Do presentations and handle experts’ questions on the meeting
*Two implants approved as Fast Track Program products (one of 9 manufacturers with 14 medical devices approved in total)

Patient follow up

Since Oct, 2020

CRC * 2
CRA * 2
Clinical Director * 1
PM * 1

*Schedule patient visits to avoid COVID impacts 

3rd party testing and report recognition assessment

Mar, May, July 2021

RA * 2
Technical Director * 2
RA Director * 1

*Analyze the specific requirements of regulations and guidelines
* Assess the testing qualification of 3rd party test labs
*Prepare corresponding test protocols

Product dossiers preparation

Oct, 2020-July, 2021

RA * 2
Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
MA * 2
PM * 1

*Cross-check FDA published data
*Multiple confirmations on the consistency in original product data from IFU, PTR, internal V&V reports etc.

Mock-up review

May-July, 2021

Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
RA * 2
PM * 1

 *Internal at least three rounds of mock-up review and guess the potential queries from the perspective of technical and clinical reviewers

Submission

Aug, 2021

RA * 1
RA Director * 1

*No technical queries on NMPA pre-review

Handling NMPA Queries

Sep-March, 2022

Technical Director * 2
RA Director * 1
Clinical Director * 1
Clinical VP * 1
RA * 2
MA * 2

*Multiple phone calls and online meeting with reviewers to do educations about product
*Prepare slides to summarize product features and handle queries from NMPA

NMPA Approval

June 2022 and July 2022 

 Two active implants approved.

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