Skip to main content

Global Medical Device Registration

In-Country Representation

Quality Management System

Supplier Audits

Medical Device Cybersecurity

Free Databases & AI Tools

All Markets Served

EN

EnglishEN
DeutschDE
日本語JA
한국어KO
EspañolES
简体中文ZH
FrançaisFR
ItalianoIT
PortuguêsPT

Site Menu

Services

Global Medical Device Registration

In-Country Representation

Quality Management System

Supplier Audits

Medical Device Cybersecurity

Free Databases & AI Tools

Resources

Blog & Articles

Industry Events

Regulatory News

Markets

All markets served

Company

All Markets Served

See all 32 markets’ access requirements on one page

Americas

Europe

Middle East / Africa

Asia Pacific

Use our Fee Calculator to get your instant estimate.

Accelerate market entry with AI-powered dossier compilation and local representation, all for a market-specific flat annual fee. Pricing varies by country, device class, and portfolio size, and excludes government fees. Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.

Get an estimate

Global Medical Device Registration

Global medical device registration consulting for devices, IVDs, and SaMD across 30+ markets.

In-Country Representation

In-country representation for medical device, IVD, and SaMD manufacturers, covering local regulatory roles.

Quality Management System

Medical device quality management system consulting for ISO 13485, FDA QMSR, MDSAP readiness and remediation.

Supplier Audits

Risk-based medical device supplier audits for qualification, surveillance, for-cause review, QMSR and ISO 13485 alignment.

Medical Device Cybersecurity

Secure connected medical devices with FDA, EU MDR, IEC 81001-5-1, testing, and lifecycle support.

Use our Fee Calculator to get your instant estimate.

Free Databases & AI Tools

Explore open MedTech databases for device registrations, clinical trials, regulations, timelines and government fees.

Regulatory updates, insights, and success stories from our experts.

Industry Events

Meet our experts at global MedTech events for networking and insights.

Regulatory News

Browse our hub for company news, regulatory updates, and insights.

Explore Our Videos

Join us for a series of videos and webinars.

UDI work order connecting device identifiers, packaging, actors and regulatory records across the US, EU and China.

One Device, Three UDI Databases

Medical Fair Asia

View Event Page

China Device GMP: 1 Nov 2026

Regulatory Update

NMPA Announcement No. 107 of 2025 replaces the 2014 medical device GMP on 1 November 2026. The revised text has 15 chapters and 132 articles, including three added chapters and separate production and market release responsibilities. The text does not specify any additional grace period after that date. Hubei and Hunan have preparation schedules.

Read Full Story

How to Register a Medical Device with the US FDA

How to Register a Medical Device with the US FDA

This video walks you through the complete FDA registration process for medical devices in the United States, from classification and documentation to appointing a US Agent and submitting your application. Learn how to navigate the world’s largest medtech market, where over 40% of global device sales take place, and where FDA clearance sets the global standard. Whether you’re a first-time entrant or expanding your US presence, this guide helps you avoid costly delays and launch with confidence.

View Video Page

Learn about our company, founders, history, awards, and social impact.

Meet the team behind our solutions and see who represents us in each region.

See the list of our locally established companies and labs around the world.

Read our team's articles published in leading media and industry platforms.

Explore our hub for company updates, achievements, and insights.

EN

EnglishEN
DeutschDE
日本語JA
한국어KO
EspañolES
简体中文ZH
FrançaisFR
ItalianoIT
PortuguêsPT

Pricing Contact us

EN

EnglishEN
DeutschDE
日本語JA
한국어KO
EspañolES
简体中文ZH
FrançaisFR
ItalianoIT
PortuguêsPT

Thank you for contacting us

We read every message and typically respond within 24 hours if a reply is required.
Want to stay in touch? Follow us on LinkedIn!

Back to homepage

Follow us on LinkedIn

Join Our Community

Receive insights on the latest events and regulatory updates directly to your inbox.

Thank you for subscribing!

Oops! Something went wrong while submitting the form!

By subscribing, you agree to our Terms of Use.

PUREGLOBAL.AI

Free Databases & AI Tools

Search official records, compare markets, plan registrations, and run regulatory workpapers—free on Pure Global AI.

Explore all free tools↗

Global data & research

Device Registrations
Global Product Search & Compare
Registry Insights
Device Directory
Clinical Trials
Regulations Library

FDA & EU databases

FDA Product Code Lookup
FDA Medical Device Recalls
FDA MAUDE Safety Reports
FDA GUDID / UDI Lookup
FDA PMA Approvals
FDA De Novo Decisions
FDA Registration & Listing
FDA TPLC Intelligence
FDA Recognized Standards
EMDN Code Finder

Planning & comparison

Global Registration Planner
Registration Timelines
Government Fees

RA & quality workpapers

Global Market Launch Workpaper
Medical Device Cybersecurity Review
Regulatory Change Impact
AI Risk Management File Review
FDA eSTAR Readiness Agent
AI CAPA Investigation Builder
Complaint & FSCA Workpaper
AI FDA QMSR Gap Review
AI Label & IFU Review
AI PMS, PMCF & CER Review

AI tools & more

AI Device Classifiers
Similar Product Finder
FDA Predicate & Pathway Agent
EUDAMED UDI XML Generator
AI EU MDR GSPR Gap Review
AI ISO 13485 Gap Review
AI MDSAP Gap Review
Company Registry
Regulation News

111 Town Square Place, Suite 1203
Jersey City, NJ 07310

Services

Market Access
Global Medical Device Registration
In-Country Representation
Quality Management System
Supplier Audits
Medical Device Cybersecurity
Pricing
EU MDR Consulting
EU IVDR Consulting

Resources

All resources
Blog
Regulatory Updates
Company News
Events
Glossary
Device Types
Case Studies

Company

Who Are We
Our Team
Our Locations
In The Media

Markets

View all markets

Americas

Europe

EU MDR Consulting

EU IVDR Consulting

Middle East / Africa

Asia Pacific

© 2026 PureVision Ai, Inc. (dba Pure Global, PureFDA). All rights reserved.

Cookie preferences

Analytics, advertising, and marketing trackers are enabled by default. You can reject or customize them at any time. Read our Privacy Policy for more information.