Regulatotry Consulting

Navigating Global Compliance Pathways

All Bright Medical provides comprehensive regulatory consulting services for medical device companies, delivering end-to-end compliance support across product registration, quality systems implementation, and clinical evaluation strategy. Our expertise translates complex regulatory requirements into actionable pathways for efficient market access.

We partner with clients to address industry-specific challenges through tailored solutions, and by integrating regulatory frameworks with practical operational insights, we transform compliance into competitive advantage—ensuring faster commercialization while maintaining rigorous quality control throughout your device lifecycle.

100
+

New Product NMPA Registrations
20
+

Innovative Medical Device Applications
30
+

New Product Registration in Major International Markets

Registration Area Coverage

China
EU
USA
Others

Registration Business Coverage

Active implant
Non-active Implant/Intervention Products
Drug-device Combination Products
Zoonotic Origin Products
Active Surgical Equipment

Comprehensive Project Experience

Experience in registration management in multiple countries

High risk product registration experience

Transnational collaborative management experience
Interdisciplinary Background

Overseas famous school/work experience

Cross disciplines, covering active, non-active, drug-device combination and zoonotic origin

Professional medical writing in English
Technology and resource integration

In-depth cooperation with several national testing agencies from lab testing, biology to animal experiments

Rich experience in regulatory communication with NMPA (including provincial and municipal bureaus), US FDA and notify bodies

Global Product Registration and Regulatory Consulting

Registration Project One-Stop Service (Project RA)

Product registration activities from project planning to approval, including but not limited to the following:

– Registration clinical pathway planning
– Output of regulatory standard list, regulatory compliance evaluation
– Preparation of product technical requirements
– Confirmation of third party commissioned testing and design & validation plan
– Clinical trial application and clinical trial filing of high-risk medical devices
– Preparation and application of registration materials, and technical communication with the evaluation department
Special Registration Project Service (Project RA)

Application for innovative/priority medical devices, including but not limited to the following:

– Patent, innovative content sorting, application strategy planning, pre-application guidance
– Preparation and application of materials, communication with the evaluation department, etc.

Application for De novo medical device

Identify the product classification and application pathway, compare with the existing 510(k) products close to the product, communicate and coordinate with the FDA, and complete the product application according to the De novo application pathway

CPR clinical trial protocol review and application

Communicate product clinical evaluation strategy, clinical trial protocol content with notified body

European clinical trial approval application

Application for approval of premarket clinical trials by authorities in EU countries
Registration Regulatory Consulting Service

Regulatory consulting services, including but not limited to the following

-Identify the product classification and attribute definition as well as application
-Research on regulations, review requirements and quality system requirements
-Assist in background checks and evaluate registration pathways for potential collaborative projects
-Communication and consultation with regulatory authorities
-Pre-review of registration material

Post-marketing compliance services, including but not limited to the following

-Maintenance of registration certificate
-Change of control and change of judgment
-Warning system maintenance

Others

-Application and maintenance of other types of certificates
-Risk management, biological evaluation requirements and regulatory support
-Regulatory training

Quality System Guidance

To help establish the quality management system and guide its effective operation, including system establishment, internal audit, simulation audit, deviation analysis and deviation closure, but not limited to the following:

EU EN ISO 13485

China Good Manufacturing Practices and Appendices for medical devices, inspection of overseas medical devices

US 21CFR 820 quality system regulations

Brazilian RDC16/2013 Good Manufacturing Practice

Medical device single audit program (MDSAP)

Laboratory quality system ISO 17025

System conformity inspection before registration application
Assist regulatory compliance/quality system audits from regulatory authorities, including routine audits, registered quality system audits, flight inspections, overseas inspections, and cause inspections
Other Related Consulting

Daily supervision consulting, commissioned production pathway consulting, regulation interpretation and other services

Instruction label review service

Review on change of design service

Assistance in adverse event report and voluntary recall

Assistance in submitting medical device report to FDA

Provide targeted training according to the situation of the enterprise

Clinical Evaluation

Writing of Clinical Evaluation Material

Assist in the preparation of clinical evaluation material for NMPA approval, including but not limited to:

Clinical evaluation exemption report: The product comparison description included in the medical device catalog for exemption from clinical evaluation

Clinical evaluation report for comparison with equivalent medical devices

Clinical evaluation report based on overseas clinical trial data

Assist in the preparation of clinical evaluation data for CE marking, including but not limited to:

SOTA, CEP, CER
Clinical Evaluation Strategy Consulting

Assist in the development of clinical evaluation strategies and regulatory feasibility:

Feasibility assessment report for clinical evaluation pathway registration

Literature search, screening, qualitative and quantitative analysis report on clinical evaluation

Regulatory compliance assessment for clinical trial protocol

Feasibility analysis of global clinical trial and overseas data reference

Others: Meta-analysis

Assist in communication with regulatory authorities (NMPA, Notified Body, FDA/English & Chinese)

Technologies