Prerequisites for Reimbursement

Regulation
PZN and HiMiPo

Both, PZN (Central Pharmaceutical Number) and HiMiPo (Medical Device Position Number), are essential for your product to be prescribed by physicians and reimbursed by statutory health insurance. We assist medical device manufacturers in navigating the application process quickly and cost-efficiently.

Explore Our Services Get In Touch

Why It Matters

Reimbursement
Only with a HiMiPo (Medical Device Position Number) can your medical product be prescribed and reimbursed.

Fast
If there is already a category of medical devices for your product, inclusion can occur within 3-4 months.

Unique Identification
Of your product to distinguish it from parallel imports.

Easy to Locate
Prescribers often search directly using the Central Pharmaceutical Number rather than the product name.

Services

Module 1
Application for a Central Pharmaceutical Number (PZN)
With a power of attorney, we apply for a PZN for your product at the IFA GmbH (Information Centre for Speciality Pharmaceuticals).

This phase includes:
- Evaluating whether a (new) PZN is necessary for your product.
- Collecting and verifying that all documents are complete and correct.
- Required documents:
  
  Commercial register excerpt or business registration
  
  Product information
  
  CE Certificates
  
  Completing and submitting the application
  
  Communication with the IFA
Special Service Offers
Application for a Medical Device Position Number (HiMiPo) under an existing product category
With a power of attorney, we apply for a HiMiPo for your product at the National Association of Statutory Health Insurance Funds for an existing product category.

This phase includes:
- Checking if your product fits into the product category
- Collecting and verifying that all documents are complete and correct
- Required documents:
  
  Product packaging
  
  Instruction for Use (IFU)
  
  Package leaflet
  
  CE Certificates
  
  Completing and submitting the application
  
  Communication with the National Association of Statutory Health Insurance Funds
Module 2
Application for a new product category in the Medical Device Directory
The Medical Device Directory lists the devices covered by statutory health insurance, which are intended for use by medically untrained laypersons.

This phase includes:
- Evaluating whether listing your product in the Medical Device Directory is possible and likely
- Guidance and navigation through the application process
Overview
Complete Overview
Click here for a complete overview of the application process and decision-making (german only).

Contact

Axel Meiling

Managing Partner

+49 (0) 151 5824 3390

healthcare@diox.de

Connect

Spotlight
Healthcare Insights

Whitepaper: Digital Health Applications (DiGA) in Portugal

25. June 2024

The whitepaper "Digital Health Applications (DiGA) in Portugal," explores the necessity and current status of implementing a DiGA framework in Portugal, offering expert insights and strategic recommendations for enhancing healthcare through digital solutions.

Webinar | Digital Devices in Pediatrics

24. May 2024

Discover the Transformative Reimbursement Pathways in Pediatric Healthcare through Our Engaging Webinar. Learn about the key aspects, benefits, and processes for achieving reimbursement for innovative healthcare solutions.

New Levers in Pharmaceutical Field Force

18. April 2024

The sales force is and remains an essential sales driver for pharmaceutical companies. But not just since the coronavirus has it become clear that the traditional sales force is in urgent need of an update.