Global Regulatory Submissions

Overview

Bringing a medical device to market anywhere in the world requires more than a good product. It requires a complete, accurate, and compliant regulatory submission that satisfies the specific requirements of each target jurisdiction. Every market has its own submission format, technical documentation depth, review process, and post-market obligations.

Veritas Quality Solutions provides end-to-end global regulatory submission support from dossier preparation and submission management to FDA listing, CE marking, cGMP green listing, and QMSR readiness. Our team understands what each regulatory authority expects and how to present your device's evidence in the format that gets results.

Whether you are pursuing a single-market approval or coordinating submissions across multiple regions simultaneously, we manage the process from start to finish so you can focus on your business.

Our Global Regulatory Submission Services

1. FDA Establishment Registration and Device Listing

Establishment Registration and Device Listing are mandatory obligations for any manufacturer, foreign exporter, or initial importer that commercially distributes devices in the United States.

What We Do:

Establishment Registration: Assist with registration of your manufacturing, repackaging, relabeling, or importation establishment via the FDA Unified Registration and Listing System (FURLS)

Device Listing: Prepare and submit device listing for each device, including the appropriate device classification, regulation number, and product code

Annual Registration Renewal: Manage the annual registration renewal process, which must be completed between October 1 and December 31 each year

US Agent Services: Provide U.S. Agent representation for foreign establishments, as required by 21 CFR 807.40

UDI and GUDID Submission: Support Unique Device Identification (UDI) assignment and submission of device identification data to the Global Unique Device Identification Database (GUDID)

2. FDA QMSR Preparations

The FDA Quality Management System Regulation (QMSR) became effective on February 2, 2026, replacing the legacy Quality System Regulation (QSR) under 21 CFR Part 820. The QMSR incorporates ISO 13485:2016 by reference, harmonizing U.S. requirements with the international standard, while retaining certain FDA-specific supplemental requirements.

What We Do:

QMSR Gap Assessment: Evaluate your current quality system against the QMSR framework, identifying gaps in documentation, terminology, and FDA-specific requirements

Procedure Remapping: Update quality manual, procedures, and records to reference ISO 13485 clauses and the new Part 820 sections (820.10, 820.35, 820.45)

Labeling and Packaging Controls: Develop procedures that satisfy the new 820.45 requirements for labeling and packaging integrity, inspection, and release

Record Control Enhancement: Align record control practices with the new 820.35 requirements, including UDI information

Management Review and Internal Audit Records: Ensure these records are documented with the awareness that they are now inspectable by FDA under the QMSR

Supplier Control Alignment: Establish supplier evaluation, qualification, and monitoring processes, including the QMSR requirement that supplier audit reports are now inspectable by FDA

Transition from QSR to QMSR: Support manufacturers migrating from the legacy QSR framework, including terminology updates (DHF, DMR, DHR replaced by the Medical Device File construct)

3. cGMP (Green Listing) Support

"Green listing" refers to the process by which a manufacturing site is verified as compliant with current Good Manufacturing Practices (cGMP), enabling the site to be listed on regulatory authority databases and facilitating market access. This is particularly relevant for manufacturers seeking to supply regulated markets where site verification is a prerequisite.

What We Do:

cGMP Gap Assessment: Evaluate your manufacturing operations against cGMP requirements, including facility design, environmental controls, process validation, and documentation practices

Site Verification Support: Prepare your facility for regulatory inspections and site verification activities

Documentation Readiness: Ensure that batch records, validation protocols, SOPs, and quality records meet cGMP expectations

Green Listing Application Support: Assist with the application process for site listing on relevant regulatory databases

Ongoing Compliance: Establish systems for maintaining cGMP compliance and preparing for periodic inspections

4. CE Mark Support (EU MDR)

The CE Mark is the mandatory conformity marking for medical devices placed on the European Union market. Under the Medical Device Regulation (EU) 2017/745 (MDR), obtaining CE Marking requires conformity assessment by a Notified Body for all but certain Class I devices.

What We Do:

Device Classification: Determine the correct classification under MDR Annex VIII, including identification of Class Is and Class Ir devices requiring Notified Body involvement for sterility and reuse aspects

Conformity Assessment Pathway: Define the appropriate conformity assessment route based on device class and characteristics

Technical Documentation Preparation: Support the development of technical documentation in accordance with MDR Annexes II and III, including device description, design and manufacturing information, GSPR checklist, risk management file, verification and validation, and labeling

Clinical Evaluation Report (CER): Prepare or review the CER in accordance with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV

Notified Body Liaison: Manage interactions with Notified Bodies, including application, documentation review, and audit coordination

EU Authorized Representative (EC REP): Provide access to EC REP services through our established panel

EUDAMED Registration: Support registration obligations in the European Database on Medical Devices (EUDAMED)

UDI Assignment and Compliance: Assist with UDI assignment, labeling, and data submission

5. UKCA Mark Support (UK MDR)

Following the UK's exit from the European Union, medical devices placed on the Great Britain market require UKCA marking under the UK Medical Device Regulations 2002 (as amended).

What We Do:

UK MDR Classification and Pathway: Determine the applicable classification and conformity assessment route

Technical Documentation Preparation: Prepare documentation aligned with UK MDR requirements

UK Responsible Person (UK REP): Provide access to UK REP services through our established panel

MHRA Registration: Support device registration with the Medicines and Healthcare products Regulatory Agency (MHRA)

UKCA Marking: Guide the process for UKCA marking and Declaration of Conformity

7. Other Key Market Authorisations

Beyond the FDA and EU, we support regulatory submissions in all major medical device markets worldwide.

Saudi Arabia (SFDA): Medical Device Marketing Authorization (MDMA)

We assist with MDMA applications through the SFDA's GHAD system, including classification, technical documentation, Authorized Representative appointment, and post-market surveillance obligations.

Brazil (ANVISA): Registration and Notification

We support ANVISA registration and notification pathways, including dossier preparation, INMETRO conformity certification where applicable, and management of the company's AFE (operating authorization).

China (NMPA): Registration and Filing

We assist with NMPA registration for imported devices, covering Class I filing and Class II/III registration applications, including clinical evaluation pathways and alignment with updated GMP requirements.

Australia (TGA): ARTG Inclusion

We support ARTG inclusion, including device classification, conformity assessment, Australian Sponsor appointment, and post-market obligations.

New Zealand (Medsafe): WAND Notification

We facilitate WAND notification, including New Zealand Sponsor appointment and use of reference country approvals to streamline market entry.

Indonesia (BPOM): Registration

We support BPOM registration through the Regalkes system, including Local Authorized Representative appointment, CSDT preparation, and distribution permit management.

Malaysia (MDA): Registration

We guide MDA registration via the MeDC@St system, including conformity assessment by verification for eligible devices and establishment licensing.

Thailand (Thai FDA): Registration

We assist with Thai FDA registration, including establishment and product license applications, and local authorized representative appointment.

Turkey (TITCK): Registration

We facilitate TITCK registration through the ÜTS portal, including UDI registration and dossier preparation, leveraging Turkey's recognition of EU conformity assessment for CE-marked devices.

Russia and EAEU: Registration

We support national registration under the Russian Ministry of Health framework and the EAEU unified registration pathway, including conformity assessment and post-market safety monitoring requirements.

Azerbaijan: State Registration

We assist with state registration for medium-risk and higher-risk devices, including dossier preparation and management of the 5-year certificate validity and renewal cycle.

Canada (Health Canada): Medical Device Licence

We support Medical Device Licence applications, including classification, quality system requirements, and post-market obligations.

Our Submission Process

Step 1: Regulatory Assessment and Strategy

We begin by assessing your device, its classification, and your target markets. This includes a review of existing documentation, identification of applicable requirements, and development of a submission strategy that prioritises markets and sequences activities efficiently.

Step 2: Dossier Preparation

We prepare or review your regulatory dossier, ensuring completeness, accuracy, and compliance with the specific requirements of each target market. This includes technical documentation, test reports, clinical evidence, labeling, and all required forms.

Step 3: Submission and Authority Interaction

We manage the submission process, including electronic filing through the appropriate portals, payment of fees where applicable, and tracking of review status. We handle all communications with regulatory authorities, including responses to questions and requests for additional information.

Step 4: Approval and Post-Market Support

Once approval is obtained, we support post-market obligations, including registration renewals, change notifications, periodic reporting, and vigilance activities.

Why Choose Veritas Quality Solutions

End-to-End Capability

From initial classification through to approval and post-market compliance, we manage the entire submission lifecycle. You do not need to coordinate multiple consultants for different markets we handle it all.

Multi-Market Expertise

Our team has direct experience with submissions in Europe, the United States, KSA, Brazil, UK, Indonesia, Malaysia, China, Australia, New Zealand, Thailand, Azerbaijan, Turkey, Russia, and other markets.

Proven Track Record

We are pioneers in Pakistan for MDR certifications, having guided companies to Class IIa, IIb, and Is certifications with SGS Belgium. We have supported device registrations across all major global markets.

Notified Body and Regulatory Authority Relationships

We maintain working relationships with Notified Bodies, authorized representatives, and regulatory consultants worldwide, giving you access to the expertise and resources needed for successful submissions.

Practical, Client-Focused Approach

We do not provide generic templates. Every submission is tailored to your device, your evidence, and your target market requirements. We work as an extension of your team, providing hands-on support at every stage.

Audit-Ready Documentation

We prepare submissions with inspection readiness in mind. When your documentation is complete, accurate, and well-organised, regulatory review becomes a verification exercise rather than a source of delay.

Get Started

Ready to bring your device to market? Contact Veritas Quality Solutions to discuss your global regulatory submission needs. Whether you are preparing a first submission, expanding into new markets, or seeking to streamline your regulatory operations, we are here to help.

Veritas Quality Solutions, Your Partner in Quality Assurance