Czech Medical Device Registration Form (SÚKL)

Streamline Medical Device Registration in the Czech Republic

Registering medical devices with the State Institute for Drug Control (Státní ústav pro kontrolu léčiv - SÚKL) requires precise documentation and comprehensive manufacturer information. This Czech Medical Device Registration Form template simplifies the complex regulatory process, helping medical device manufacturers, distributors, and authorized representatives submit accurate applications that meet Czech and EU regulatory standards.

Built for Medical Device Regulatory Compliance

Whether you're a domestic manufacturer or an international company entering the Czech market, this template guides applicants through every required field—from basic company identification (IČO and DIČ) to detailed device specifications, classification codes, and conformity assessment documentation. The structured format ensures nothing is overlooked, reducing back-and-forth with regulatory authorities and accelerating approval timelines.

Medical device companies use this form to:

• Register new medical devices with SÚKL under Czech Act No. 268/2014 Coll. on Medical Devices
• Submit manufacturer and authorized representative details including all required Czech business registration numbers
• Declare device classification according to EU MDR/IVDR regulations
• Upload conformity certificates, technical documentation, and labeling samples directly within the application
• Ensure compliance with both Czech national requirements and EU Medical Device Regulation (MDR 2017/745)

Why Medical Device Professionals Choose Paperform

Regulatory submissions demand accuracy, organization, and complete documentation. Paperform's intelligent form builder helps medical device companies create professional, compliant applications that work seamlessly with Czech regulatory workflows.

Conditional logic adapts the form based on device classification—Class I devices trigger different documentation requirements than Class IIa, IIb, or III devices. Questions about notified body certificates only appear when relevant, keeping the form streamlined while capturing every necessary detail.

File upload fields let applicants attach certificates of conformity, declaration of conformity (DoC), technical documentation summaries, instructions for use (IFU), and labeling samples all in one submission. No more scattered email attachments or missing documents.

Calculation and validation fields automatically format IČO and DIČ numbers correctly, validate EUDAMED UDI-DI codes, and ensure date fields follow the proper Czech format (DD.MM.YYYY).

Seamless Integration with Your Regulatory Workflow

Medical device regulatory affairs teams can connect this form to their existing systems using Paperform's powerful integrations. Send new submissions directly to your document management system, log applications in Airtable or Google Sheets for tracking, or trigger approval workflows in your project management tools.

For teams managing multiple registrations across EU member states, Stepper (stepper.io) can automate your post-submission workflow—routing applications to different team members for review, sending follow-up reminders for missing documentation, updating your regulatory affairs database, and notifying stakeholders when SÚKL approval is received.

If your registration process requires signed declarations or authorized representative agreements, Papersign (papersign.com) lets you turn form submissions into legally binding eSignature documents, keeping everything connected to the original application for a complete audit trail.

Professional, On-Brand Regulatory Forms

Even regulatory submissions benefit from professional presentation. Paperform's doc-style editor lets you add your company logo, match your brand colors, and create forms that look polished and trustworthy—important when dealing with regulatory authorities and building confidence with Czech healthcare partners.

Forms can be embedded directly on your regulatory affairs portal or hosted on a custom domain, giving international manufacturers a localized, professional presence when entering the Czech market.

Trusted by Medical Device Companies Worldwide

Medical device manufacturers, distributors, regulatory consultancies, and quality assurance teams across Europe trust Paperform for regulatory submissions and compliance documentation. With SOC 2 Type II compliance, robust data security, and GDPR-ready infrastructure, your sensitive regulatory and business information stays protected throughout the submission process.

Whether you're registering a single diagnostic device or managing a portfolio of medical equipment across EU markets, this Czech Medical Device Registration Form template gives you the structure, compliance support, and automation you need to navigate SÚKL requirements efficiently.

Start with this template and customize it to match your specific device categories, internal approval processes, and regulatory workflow—then connect it to your quality management system to keep every registration organized, documented, and audit-ready.