GH Strategies supports manufacturers, importers, innovators, and distributors by preparing high-quality device dossiers, evaluating risk class requirements, and ensuring your device is positioned for successful registration and market entry.
What GH Strategies Delivers
Device Classification & Regulatory Pathway Strategy
We determine the correct SAHPRA risk class (A–D) and define the appropriate registration pathway, documentation requirements, and evidence needed to support your device.
Technical File & Dossier Architecture
Your dossier is structured according to GHTF/IMDRF medical device standards, incorporating design evidence, safety data, performance validation, and device-specific risk controls.
Clinical, Performance & Safety Evidence Alignment
We ensure your clinical evaluation report (CER), performance studies, and risk documentation meet SAHPRA’s expectations for your device’s classification and intended use.
Labelling, IFU & Device Information Compliance
GH Strategies evaluates and aligns all device labelling, packaging, IFUs, and product descriptions to ensure compliance with SAHPRA device guidelines.
Regulatory Liaison & Submission Communication
We manage your communication with SAHPRA, coordinate responses to queries, and ensure your submission remains complete, compliant, and strategically defensible.
Post-Market Surveillance & Vigilance Integration
We align your PMS, incident reporting, and vigilance systems with SAHPRA and ISO 13485 expectations to support lifecycle compliance after registration.
Planning to register or introduce a medical device in South Africa?
Four Pillars of a SAHPRA-Ready Market Access Strategy
Strategic Value of Device Market Access
We position your medical device for successful registration by aligning it with SAHPRA requirements, strengthening regulatory credibility, and ensuring a controlled, compliant path from approval to market.
Regulatory Validation
Successful device registration confirms safety and performance, builds regulatory trust, and positions your product competitively within the South African market.
Market Access Partner
GH Strategies prepares and optimises your dossier, resolves compliance gaps, and works with licensed wholesalers to establish approved, compliant distribution channels.
Operational Confidence and Control
A strong submission accelerates registration timelines, supports ethical procurement, strengthens partner confidence, and reduces regulatory and operational risk.
Frequently Asked Questions (FAQs)
All Class B, C, and D devices require registration. Some Class A devices require listing depending on risk and intended use.
Yes, they strengthen your technical file but do not replace SAHPRA’s evidence and documentation requirements.
Yes, importers must ensure that all imported risk-based devices have valid SAHPRA registrations.
Yes, depending on the sIt is not legally mandatory for all applicants, but SAHPRA expects ISO 13485-aligned QMS evidence for most device classes.tage of production. Cultivation requires GACP principles, while processing and manufacturing require GMP alignment.
Timelines vary based on device class, evidence completeness, and SAHPRA review cycles; strong dossiers reduce delays significantly.
Yes, we assess missing evidence, non-compliant sections, and areas requiring redesign before submission.
Let’s Build Something That Lasts
Partner with GH Strategies to secure a compliant, audit-ready cannabis licence.