AI & Digital Health_Deda Enterprise Management Consulting

Service Items
- Domestic
- International
Annual Consulting

Domestic & Overseas Regulatory Consultation & Interpretation

On-site Coaching

Mock Audit

Domestic & Overseas Regulatory Training

Corporate Compliance Consultancy

Global Market Access Route Planning for Products

Process Validation Optimization Advice
Preparations

Pre-registration Preparation

R&D & Verification

Registration Application Planning

Plant & Workshop

GMP System

Pilot Production
Inspection & Evaluation

Registration Testing

Biological Evaluation

Animal Testing

Clinical Evaluation

Clinical Trials
Application & Review

Dossier Preparation

Pre-acceptance Consultation

Acceptance

Supplementary Request & Expert Meeting

GMP System Inspection

Registration Approval
Licensing & Amendments

Manufacturing License Application

Business License Application

Registration Modification

Registration Renewal
Post-market Management

Instructions Revision

Other Post-market Matters
Annual Consulting

Domestic & Overseas Regulatory Consultation & Interpretation

On-site Coaching

Mock Audit

Domestic & Overseas Regulatory Training

Corporate Compliance Consultancy

Global Market Access Route Planning for Products

Process Validation Optimization Advice
United States

Medical Device Registration Classification

Q-Sub/Pre-Sub Pre-Submission Consultation

Medical Device 510(k) Premarket Notification

Enterprise Registration & Product Listing

PMA Premarket Approval (For High-Risk Class III Devices)

Quality System Compliance
European Union

Market Access Strategy

Technical Documentation & Clinical Services

Quality & Risk Management Systems

Software & Digital Health Compliance

Packaging & Labeling Compliance

Audit & Inspection Preparation
Other Countries

Japan

Southeast Asia

Middle East

Australia
Professional Fields

Medical Devices

Medical device compliance consulting to accelerate registration approval.

In Vitro Diagnostics

IVD regulatory guidance for global market access.

Software-based Medical Devices

Regulatory support for medical device software development and certification.

AI & Digital Health

Compliance planning for AI & digital health products for safe market launch.
Knowledge Center

Laws & Regulations

National Standards · Industry Standards · Guidelines · Overseas Regulations

Training & Certification

Complete relevant video courses and assessments within the specified time to obtain the corresponding certificate.

Public Welfare Module

Online training · Offline salon

Q&A Knowledge Base

How to determine the classification of medical devices?
How to confirm the clinical evaluation pathway of products?
About Us

Company Profile

Specializes in pre-market regulatory and technical consulting services for medical devices.

Contact Us

Contact us for tailored consulting services.

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Deda MedCheck
(Global Medical Device Search)

04

AI & Digital Health

Home > Professional Fields > AI & Digital Health

Medical Devices

In Vitro Diagnostics

Software-based Medical Devices

AI & Digital Health

05-11

2026

From R&D to registration of continuous glucose monitoring systems:Key points on early layout and evidence chain management for CGM projects As diabetes management evolves toward precision, continuity and digitalization, continuous glucose monitoring (CGM) systems have emerged as one of the high-profile product categories in the medical device industry. The National Medical Products Administration has released the guidelines for technical review of CGM registration, with its revised 2023 version included in the current catalogue of medical device registration review guidelines. Multiple CGM products have also obtained marketing clearance via the 510(k) pathway as available in the FDA database.

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05-11

2026

Where lies the difficulty in clinical trial design for AI medical devices? Sample size, gold standard, endpoint and stratified analysis cannot be neglected After AI medical devices enter the registration application phase, project teams tend to prioritize algorithm indicators. Nevertheless, in registration clinical trials, regulators focus not merely on algorithm accuracy, but on whether the device can generate reviewable, verifiable and extrapolatable clinical evidence under defined intended use, target population, clinical workflow and practical usage environment.

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04-29

2026

Analysis of key technical review points for registration of orthopedic surgical navigation systemsCompliance routes and core considerations from review experts' perspective As Class III high-risk high-end medical devices integrating medical imaging, spatial positioning, computer-aided design and precision mechanical control, orthopedic surgical navigation systems feature high technical complexity, high risk level and stringent review requirements in registration application. From the review perspective, technical review outcomes directly affect patients' surgical safety and clinical efficacy, thus rigorous scientific prudence must be maintained throughout the review process.

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04-29

2026

Digital health medical devices enter practical registration phase:How should applicants make advance layout covering software, data and clinical evidence? After digital health products shift from concept verification to practical registration, applicants need to prioritize core questions beyond product innovation: whether the product falls under medical device scope, its classification category, and whether software, data, algorithms and clinical evidence can support registration submission. this article serves as the opening chapter of digital health medical device registration series, helping project teams build a compliance evaluation framework at early project initiation.

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