Farmatec

Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry.

Farmatec is a Dutch organization that provides essential services for the registration and approval of medical devices and medicinal products. They assist the pharmaceutical industry by obtaining necessary permits, approvals, and Free Sales Certificates. Operating from Den Haag, Farmatec is part of the CIBG agency. They offer guidance and support for various regulatory processes, including those related to medicinal products, medical devices, and in-vitro diagnostics (IVDs). Farmatec's services are crucial for companies navigating the complex regulatory landscape in the Netherlands and potentially the EU. Their expertise ensures compliance and facilitates market access for a wide range of healthcare products. They can be contacted via email, telephone, or postal mail for inquiries and support.

About

**Who they are**
Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry. They are part of the CIBG agency.

**Expertise & scope**
* Registration and approval of medical devices and medicinal products
* Services for permits and Free Sales Certificates
* Support for Add-on medicins
* Assistance with Certificate of a Pharmaceutical Product (CPP)
* Services related to Free sales certificates and registrations for medical devices and in-vitro diagnostics (IVD's)
* Support for Pharmaceutical Permits and Exemptions (V&O)
* Guidance for Import and Export opium law resources for pharmaceutical companies
* Assistance with Maximum prices medicines
* Support for Online providers medicines
* Services for Reimbursement of medicines

**Reputation / proof points**
Farmatec operates within the EU.

Additional information

Farmatec provides contact information for various specialized services, including those related to medicinal cannabis, medical devices, and pharmaceutical permits. They are accessible Monday through Friday, 8:30 AM to 5 PM. For those unsatisfied with their services, Farmatec advises discussing the issue with the concerned employee or manager first. If a resolution is not reached, complaints can be directed to the CIBG agency, of which Farmatec is a part.

Key Highlights

  • Specializes in registration and approval of medical devices and medicinal products. Source
    “Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry.”
  • Offers services for permits and Free Sales Certificates. Source
    “Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry.”
  • Provides support for a range of pharmaceutical regulatory areas including CPP, medical devices, and import/export. Source
    “Free sales certificates and registrations medical devices and in-vitro diagnostics (IVD's) medische_hulpmiddelen@minvws.nl +31 70 340 61 61 Certificate of a Pharmaceutical Product (CPP) _dienstpostbusCIBGWGP@minvws.nl +31 70 340 66 24 Import and Export opium law resources for pharmaceutical companies dienstpostbusCIBGinenuitvoerOWM@minvws.nl +31 70 340 79 17 / 73 83”

Certifications & Trust Signals

  • Farmatec is part of the CIBG agency. Source
    “Farmatec is part of the CIBG agency.”

Buyer Snapshot

Best for
  • Companies seeking registration and approval for medical devices and medicinal products
  • Businesses requiring permits and Free Sales Certificates in the pharmaceutical industry
How engagement typically works
  • Direct consultation via email or telephone
  • Formal complaint process through CIBG agency if needed
Typical deliverables
  • Registration support for medical devices and medicinal products
  • Permits and Free Sales Certificates
  • Assistance with various pharmaceutical regulatory processes
Good to know
  • Best when requiring specialized support within the pharmaceutical and medical device sectors in the EU.
HQ: Den Haag, NL
Languages: English
Timezones: Europe/Brussels
Status: listed

Services & Capabilities

Best EUDAMED Registration| Compare & Get Quotes

Jurisdictions: EU
Countries: DE, DK, IT, BE, FR, ES
Industries: Medical devices, IVD, SaMD, Manufacturing
Portfolio: 26-100
Onboarding time: 3–21 days
Pricing model: Onboarding + annual retainer
Starting from: EUR 2,500
Included services: Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration: Yes
Supports UDI: Yes
Supports Data Load: No
Modules Supported: Actor/SRN, Certificates
Supports Training Enablement: No
Data Load Support Level: Training only
Turnaround SLA: Custom

Additional eudamed_reg_support Details

Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Contact via email or telephone; discuss issues internally first; escalate complaints to CIBG agency if necessary.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices, Certificates & Notifications (implied by Free Sales Certificates and CPP)
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
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