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.

NMPA First Approved ENT Active Implant With Real World Data