First Diagnostic™ Corporation
International Distributor Qualification & Country Authorization Application
1. APPLICATION INFORMATION
Application Type *— Select Application Type — New Distributor Application Existing Distributor – Additional Territory Existing Distributor – Additional Product Line Importer Application Government / Tender Supplier Healthcare Distribution Partner Retail / Pharmacy Distribution Partner Strategic Commercial Partner Other
Relationship Requested *— Select Requested Relationship — Authorized Distributor Authorized Importer Importer and Distributor Non-Exclusive Distributor Exclusive Distributor Master Distributor Regional/Sub-Distributor Government Tender Supplier Retail / Pharmacy Distributor Hospital / Laboratory Distributor Other
Primary Country for Requested Authorization *
Requested Territory / Region *
Is nationwide distribution coverage available? *Yes No Partial Coverage
If partial coverage, identify areas covered
2. APPLICANT COMPANY INFORMATION
Full Legal Company Name *
Trading / DBA Name
Company Type *— Select Company Type — Medical Device Distributor Medical Device Importer Importer / Distributor IVD Distributor Pharmaceutical / Medical Distributor Healthcare Supplier Hospital Supplier Laboratory Supplier Government Contractor Tender / Procurement Company Retail / Pharmacy Distributor E-Commerce Healthcare Distributor Manufacturer Representative Other
Year Company Established *
Company Registration / Incorporation Number *
Tax / VAT / Business Identification Number *
Company Website *
General Company Email *
Main Company Telephone *
Number of Employees *
Number of Employees Dedicated to Medical Device Sales
Number of Dedicated Sales Representatives
Number of Regulatory / Quality Personnel
3. REGISTERED BUSINESS ADDRESS
Street Address *
Address Line 2
City *
State / Province / Region *
Postal / ZIP Code *
Country *
Is this also the primary warehouse location? *Yes No
4. PRIMARY BUSINESS CONTACT
Full Name *
Job Title *
Business Email *
Direct Telephone *
WhatsApp / Mobile Number
Preferred Method of Communication *— Select — Email Telephone WhatsApp Video Conference
Primary Business Language *
English proficiency for commercial/regulatory communication *— Select — Fluent Professional Intermediate Limited
5. EXECUTIVE / AUTHORIZED COMPANY OFFICER
Authorized Officer / Executive Name *
Title *
Email *
Telephone
Is this person authorized to execute distribution agreements? *Yes No
6. REGULATORY AFFAIRS CONTACT
Regulatory Affairs Contact Name *
Title
Email *
Telephone
Is regulatory work performed internally or externally? *Internal Regulatory Department External Regulatory Consultant Both No Dedicated Regulatory Function
If an external regulatory consultant or Authorized Representative is used, provide details
7. QUALITY ASSURANCE CONTACT
Quality Assurance / Quality Manager
Email
Telephone
8. LOCAL MEDICAL DEVICE REGULATORY AUTHORITY
Name of Medical Device / IVD Regulatory Authority *
Regulatory Authority Website
Primary medical-device legislation/regulation applicable in your country
Are medical devices or IVDs required to be registered before importation or sale? *Yes No Depends on Device Classification
Does your country maintain a separate IVD regulatory classification system? *Yes No Unknown
Describe the medical-device / IVD classification system
Who is legally permitted to submit a device registration? *Foreign Manufacturer Local Authorized Representative Importer Distributor Registration Holder Local Legal Entity Other
Must a foreign manufacturer appoint an in-country Authorized Representative / Registration Holder? *Yes No Depends on Device
If yes, can your organization serve in this capacity?Yes No Through an Affiliate / Partner
Describe the registration procedure for diagnostic medical devices in your country *
Typical regulatory registration timeline *
Estimated government registration fees
Registration validity / renewal period
9. IMPORTER / DISTRIBUTOR LICENSE INFORMATION
Does your company hold a valid medical-device importer license? *Yes No Not Required
Importer License Number
Importer License Expiration Date
Does your company hold a valid medical-device distributor license? *Yes No Not Required
Distributor License Number
Distributor License Expiration Date
Other Government / Healthcare Supplier License Numbers
Has your company's license ever been suspended, restricted, revoked or placed under enforcement action? *No Yes
If yes, provide complete details
10. PRODUCT REGISTRATION EXPERIENCE
Has your organization previously registered medical devices or IVD products in this country? *Yes No
Approximate number of medical device / IVD registrations completed
Provide examples of diagnostic products successfully registered
Have you registered products from U.S. manufacturers?Yes No
Have you registered rapid diagnostic tests / lateral flow assays?Yes No
Describe your regulatory team's experience
11. DOCUMENTS REQUIRED FOR PRODUCT REGISTRATION
Please identify documents normally required by your country's authority:
Certificate of Free Sale Certificate to Foreign Government ISO 13485 Certificate ISO 9001 Certificate Manufacturer Establishment Certificate FDA Documentation CE Documentation Declaration of Conformity Technical File / Technical Documentation Device Master File Clinical Performance Data Analytical Performance Data Risk Management Documentation Instructions for Use Product Labeling Packaging Artwork Stability / Shelf-Life Data Certificate of Analysis Manufacturing Information Quality System Documentation Letter of Authorization Power of Attorney Notarized Documents Apostilled Documents Embassy / Consular Legalization Product Samples Local Laboratory Testing Other
Explain any additional country-specific documentation requirements
Are original/notarized/apostilled/legalized documents required?Yes No Some Documents
Describe legalization requirements
12. PRODUCT CATEGORIES OF INTEREST
Select all applicable categories:
Rapid Diagnostic Tests / RDTs Point-of-Care Diagnostic Tests Lateral Flow Assays Infectious Disease Diagnostics Cardiac Marker Diagnostics Oncology / Cancer Diagnostics Women's Health Diagnostics ToRCH Diagnostics Sexually Transmitted Infection Diagnostics Respiratory Disease Diagnostics Drugs of Abuse Testing Gastrointestinal Diagnostics Tropical / Vector-Borne Disease Diagnostics Electronic / Digital Diagnostic Readers AI-Assisted Diagnostic Readers Professional-Use Diagnostic Products Other
Specific First Diagnostic™ products of interest *
Primary intended customer segments *Hospitals Clinical Laboratories Physician Offices Urgent Care Centers Government Healthcare Facilities Military Healthcare Public Health Programs Pharmacies Retail Chains Medical Distributors NGOs International Aid Organizations Private Clinics Occupational Health Corporate Health Programs Other
13. PRODUCT LABELING & LOCALIZATION REQUIREMENTS
Required product labeling language(s) *
Required Instructions for Use language(s) *
Is translation by a locally certified translator required?Yes No Unknown
Are local importer/distributor details required on labeling?Yes No Depends on Product
Are registration numbers required on the product or packaging?Yes No Depends on Product
Are UDI requirements applicable?Yes No Future Requirement Unknown
Describe any country-specific labeling, barcode, serialization, UDI or packaging requirements
14. QUALITY MANAGEMENT SYSTEM
Does your company maintain a documented Quality Management System? *Yes No
Quality certifications heldISO 9001 ISO 13485 Good Distribution Practice / GDP Good Storage Practice / GSP National Medical Device QMS Certification Other None
Certification Body
Certificate Number(s)
Certificate Expiration Date
Does your QMS include document control?Yes No
Does your QMS include supplier qualification?Yes No
Does your QMS include product traceability?Yes No
Does your QMS include complaint handling?Yes No
Does your QMS include CAPA procedures?Yes No
Does your QMS include product recall procedures?Yes No
15. WAREHOUSING & STORAGE CAPABILITIES
Does your company operate its own warehouse? *Yes No Third-Party Logistics Provider
Number of warehouse locations
Warehouse location(s)
Approximate total warehouse capacity
Are warehouse temperature conditions monitored?Yes No
Is temperature monitoring continuous and documented?Yes No
Is humidity monitored where required?Yes No
Does the warehouse maintain calibrated monitoring equipment?Yes No
Inventory system used
Can your system track product by lot / batch number?Yes No
Can your system track expiration dates?Yes No
Is FEFO (First Expired, First Out) inventory management used?Yes No
Describe warehouse and storage procedures
16. IMPORTATION & CUSTOMS CAPABILITY
Does your organization currently import medical devices? *Yes No
Approximate number of medical-device shipments imported annually
Primary port(s) / airport(s) of entry
Do you have an established customs broker?Yes No
Customs Broker / Freight Forwarder
Can you act as Importer of Record?Yes No
Are import permits required for each shipment?Yes No Depends on Product
Describe customs clearance and import procedures for IVD/medical devices
Are pre-shipment inspections required?Yes No
Are Certificates of Analysis required with individual shipments?Yes No Depends on Product
17. SALES & DISTRIBUTION CAPABILITIES
How many years has your organization distributed medical devices? *
How many active healthcare customers does your company currently serve?
Approximate number of hospitals served
Approximate number of laboratories served
Approximate number of pharmacies / retail locations served
Geographic sales coverage *
Describe your sales force structure *
Major healthcare customers or customer categories
Major brands / manufacturers currently represented
Do you distribute products that directly compete with First Diagnostic™ products? *Yes No
If yes, identify manufacturer(s) and competing product(s)
18. SALES CHANNELS
Select all channels where your company has active sales capability:
National Distributors Regional Distributors Sub-Distributors Hospitals Clinical Laboratories Physician Offices Urgent Care Centers Government Procurement Ministry of Health Military / Defense Healthcare Public Health Programs NGOs International Aid Programs Pharmacies Retail Pharmacy Chains Independent Pharmacies Healthcare Retail E-Commerce Corporate / Occupational Health Private Clinics Universities / Research Institutions Other
19. GOVERNMENT & TENDER EXPERIENCE
Does your company participate in government tenders? *Yes No
Is your company registered as an approved government supplier?Yes No
Government Supplier Registration Number
Government agencies / ministries supplied
Describe relevant medical-device tender experience
Largest diagnostic/medical-device tender successfully supplied, if appropriate
Does your company have personnel dedicated to tender preparation and submission?Yes No
20. MARKETING CAPABILITIES
Does your company have an internal marketing department?Yes No
Marketing capabilitiesMedical Conferences Trade Shows Clinical Education Hospital Presentations Digital Marketing Email Marketing Social Media Distributor Training Physician Outreach Laboratory Outreach Pharmacy Marketing Government Relations Tender Marketing Website / E-Commerce Field Demonstrations Other
Describe your proposed strategy for launching First Diagnostic™ products *
Major medical trade shows or conferences attended annually
21. TECHNICAL & CUSTOMER SUPPORT
Does your company maintain a customer service department?Yes No
Does your company provide product training to customers?Yes No
Does your company employ clinical or laboratory specialists?Yes No
Does your company employ biomedical / technical service personnel?Yes No
Describe your customer and technical support capabilities
22. POST-MARKET SURVEILLANCE & COMPLAINT HANDLING
Does your company maintain written complaint-handling procedures? *Yes No
Can complaints be traced to product lot/batch and customer?Yes No
Does your company maintain an adverse-event reporting procedure?Yes No
Does your country require distributors/importers to report adverse events?Yes No Unknown
Does your company maintain a field safety corrective action / recall procedure?Yes No
Can your company rapidly identify customers receiving a specific lot/batch?Yes No
Describe post-market surveillance and regulatory reporting requirements in your country
23. COMMERCIAL FORECAST
Requested Commercial Launch Timeline *— Select — Immediately After Approval Within 3 Months 3–6 Months 6–12 Months 12–18 Months More Than 18 Months Dependent on Regulatory Registration
Estimated First-Year Purchase Volume
Estimated Second-Year Purchase Volume
Estimated Third-Year Purchase Volume
Estimated Initial Order
Currency Used for Commercial Transactions *
Preferred Shipping Terms / IncotermsEXW FCA FOB CIF CIP DAP Other / To Be Negotiated
Preferred payment structureAdvance Payment Wire Transfer Letter of Credit Credit Terms – Subject to Approval Government Procurement Terms Other / To Be Negotiated
24. EXCLUSIVITY REQUEST
Are you requesting exclusive distribution rights? *No Yes
If requesting exclusivity, explain the commercial basis for the request
Proposed minimum annual purchase commitment
Marketing investment your company is prepared to commit annually
25. FINANCIAL & COMMERCIAL CAPABILITY
Company Ownership *— Select — Privately Held Publicly Traded Government Owned Subsidiary Joint Venture Other
Parent Company, if applicable
Approximate Annual Medical Device Sales
Can your company provide commercial/trade references upon request? *Yes No
Can your company provide financial information if required for credit approval? *Yes No
26. BUSINESS REFERENCES
Reference #1
Company
Contact Name
Email
Telephone
Business Relationship
Reference #2
Company
Contact Name
Email
Telephone
Business Relationship
27. COMPLIANCE & BUSINESS INTEGRITY
Has the company, any owner, officer, or director been debarred or prohibited from participating in medical-device or government procurement activities? *No Yes
Has your company been subject to material medical-device regulatory enforcement during the previous five years? *No Yes
Has your company been subject to a material product recall during the previous five years? *No Yes
Has your organization or any controlling owner/officer been sanctioned for bribery, corruption, fraud, customs violations, or healthcare procurement violations? *No Yes
If any answer above is Yes, provide details
Does your organization maintain anti-bribery / anti-corruption policies?Yes No
Does your organization maintain a compliance or code-of-conduct policy?Yes No
Does your company conduct compliance training for relevant employees?Yes No
28. DOCUMENT UPLOADS
Certificate of Incorporation / Business Registration *
Medical Device Distributor License
Medical Device Importer License
ISO / QMS Certificate
Government Supplier / Tender Registration
Company Profile / Corporate Presentation
Proposed First Diagnostic™ Market / Launch Plan
Additional Supporting Document
29. ADDITIONAL INFORMATION
Why does your organization want to represent First Diagnostic™ Corporation? *
What differentiates your company from other medical-device distributors in your market? *
Describe the market opportunity for First Diagnostic™ products in your country *
Identify major competitors in your market
Additional information or comments
30. CERTIFICATION & AUTHORIZATION
I certify that the information provided in this application is accurate,
complete, and current to the best of my knowledge and that I am authorized
to submit this application on behalf of the applicant company.
I authorize First Diagnostic™ Corporation to verify company registration,
regulatory licenses, business references, certifications, and other information
submitted as reasonably necessary to evaluate this distributor application.
I understand that acceptance or appointment by First Diagnostic™ Corporation
as a distributor, importer, representative, or commercial partner does not
constitute governmental regulatory approval. No product may be marketed,
promoted, imported, distributed, tendered, or sold unless all applicable
regulatory and legal requirements in the applicable country have been satisfied.
I acknowledge that any appointment will be subject to applicable medical-device
laws, import/export requirements, sanctions and trade-control laws,
anti-bribery and anti-corruption requirements, contractual requirements,
and First Diagnostic™ Corporation compliance policies.
I consent to First Diagnostic™ Corporation contacting the applicant and
processing the business information submitted for distributor qualification,
regulatory due diligence, commercial evaluation, and related communications.
Name of Authorized Signatory *
Title *
Company *
Date *
Electronic Signature / Type Full Legal Name *
