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.
**Expertise & scope**
* Registration and approval of medical devices and medicinal products
* Services for permits and Free Sales Certificates
* Support within the pharmaceutical industry
**Reputation / proof points**
* Coverage: EU
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.
**Expertise & scope**
* Registration and approval of medical devices and medicinal products
* Services for permits and Free Sales Certificates
* Support within the pharmaceutical industry
**Reputation / proof points**
* Coverage: EU
Additional information
Farmatec operates within the CIBG agency framework. They provide contact information for various services including Add-on medicins, Certificate of a Pharmaceutical Product (CPP), Free sales certificates and registrations for medical devices and in-vitro diagnostics (IVD's), Pharmaceutical Permits and Exemptions (V&O), Import and Export opium law resources, Maximum prices medicines, Online providers medicines, and Reimbursement of medicines. They also have a process for handling complaints, encouraging initial discussion with the concerned employee or manager before escalating to the CIBG agency if necessary.
Key Highlights
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Specializes in the 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.”
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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.”
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Provides support within the pharmaceutical industry.
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.”
Certifications & Trust Signals
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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
How engagement typically works
- Direct service provision for regulatory processes
- Support for navigating pharmaceutical industry regulations
Typical deliverables
- Registration and approval documentation
- Permits
- Free Sales Certificates
Good to know
- Best when engaging with the pharmaceutical and medical device sectors
HQ:
Den Haag, NL
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
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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, UDI/Devices, 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. For complaints, discuss with the employee/manager first, then escalate to CIBG agency if needed.
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
Supports Actor Registration
No
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
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