Medical Questionnaire – AFrpharmac Consulting

Step 1 of 5 20%

Medical Medical Track — Step 1 of 5

Medical Type & Classification

Tell us about the medical Medical you are seeking to register.

1What is the Medical risk classification?

Class I — Low risk (e.g. bandages, examination gloves) Class IIa — Moderate risk (e.g. hearing aids, contact lenses) Class IIb — Higher risk (e.g. ventilators, infusion pumps) Class III — Highest risk (e.g. pacemakers, implants) In Vitro Diagnostic (IVD) Not sure of classification

2Which category best describes your Medical?

Diagnostic Equipment Therapeutic / Treatment Medical Surgical Instrument Implantable Medical Consumer Health / Wellness Medical Other

Medical Medical Track — Step 2 of 5

Target Market

Which regulatory authorities are you targeting?

3Primary target regulatory authority (select all that apply)

NAFDAC (Nigeria) PPB (Kenya) / TFDA (Tanzania) SAHPRA (South Africa) FDA Ghana Other African Market

4Does your Medical already hold approval in another major market?

Yes — CE Mark (EU) Yes — US FDA 510(k) or PMA Yes — both CE Mark and US FDA Yes — other reference market No — first-time market application

Medical Medical Track — Step 3 of 5

Technical Documentation Readiness

Rate your current status for each required technical document.

5Medical Description & Specifications

Complete In Progress Not Started

6Risk Management File (ISO 14971 or equivalent)

Complete In Progress Not Started

7Biocompatibility / Safety Testing (ISO 10993)

Complete In Progress Not Started Not Applicable

8Clinical Evidence / Performance Data

Full clinical investigation data available Literature review / equivalence data only Partial data / ongoing study No clinical data yet

9Quality Management System (ISO 13485)

Yes — ISO 13485 certified In progress / audit pending No — not yet implemented

Medical Medical Track — Step 4 of 5

Manufacturing & Post-Market

Final checks on manufacturing and post-market surveillance readiness.

10Do you have a local authorised representative in the target market?

Yes — agreement signed In discussion / not yet signed No — not yet identified Registering directly (no distributor needed)

11Do you have a Post-Market Surveillance (PMS) plan?

Yes — documented and in place Partially in place Not yet developed

12What is your estimated timeline to submit your dossier?

Under 3 months 3–6 months 6–12 months More than 12 months / still exploring

Medical Medical Track — Step 5 of 5

Get Your Pre-Submission Gap Report

Enter your details to receive your personalised Medical pre-submission gap analysis.

Full Name *

Email Address *

Company / Organisation *

Country *

Job Title / Role

By submitting you agree to receive your gap report and occasional regulatory insights from afrpharmac.com.

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