Medical Device Regulatory Affairs

Specialist regulatory consulting and local representation for medical device and IVD manufacturers, covering regulatory strategy, SAHPRA compliance and ongoing product lifecycle responsibilities.

Regulatory Strategy & Compliance

Regulatory Oversight Throughout the Product Lifecycle.

Medical device regulatory compliance extends beyond initial market entry. Manufacturers and suppliers must account for changing SAHPRA requirements, product modifications, post-market surveillance, safety reporting and ongoing regulatory responsibilities.

Verion Medical supports medical device and IVD companies with regulatory strategy, local representation, compliance assessments and post-market regulatory affairs.

Our Medical Device Regulatory Affairs Services

Regulatory Strategy & Compliance Assessments

Assessment of regulatory obligations, compliance gaps and product lifecycle requirements, with practical recommendations aligned with the South African medical device regulatory framework.

Local Regulatory Representation & SAHPRA Liaison

Local regulatory representation and coordination for international manufacturers, including regulatory correspondence, authority enquiries and documentation oversight

Regulatory Intelligence & Compliance Updates

Monitoring and assessment of SAHPRA regulatory developments, revised guidelines and policy changes, with advice on their implications for medical device and IVD businesses.

Product Lifecycle & Change Management

Regulatory impact assessments for changes to medical devices, intended use, labelling, manufacturer information and other product or business arrangements that may affect compliance.

Medical Device Vigilance & Safety Reporting

Support for medical device adverse-event assessment, reporting obligations, regulatory communications and follow-up activities in accordance with applicable SAHPRA vigilance requirements.

Post-Market Surveillance & Field Safety Actions

Regulatory support for post-market surveillance, safety trend assessments, field safety corrective actions, product recalls and associated reporting responsibilities.

Explore Our Service
Discuss Local Representation
Specialist Regulatory Support

Regulatory Affairs for In Vitro Diagnostics

01.

IVD Regulatory Support

Specialist regulatory services for in vitro diagnostic medical devices, including diagnostic intended use, product classification, performance evidence, self-testing considerations and applicable SAHPRA requirements.

Why Verion Medical?

1

A Local Regulatory Contact

Work with a regulatory team that understands SAHPRA requirements and can coordinate regulatory matters on your behalf.
2

Stay Ahead of Regulatory Changes

Understand how new guidelines and regulatory developments affect your medical devices before they create compliance issues.
3

Support After Market Entry

Maintain regulatory oversight as products change, safety information emerges and post-market obligations develop.

Are Your Regulatory Responsibilities Changing?
Speak to an Expert.

Contact us now

Before You Get Started

FREQUENTLY ASKED QUESTIONS

1. What is the difference between a local legal representative and a SAHPRA Authorised Representative?
A local legal or regulatory representative may be appointed under a contractual agreement to coordinate regulatory matters on behalf of an international manufacturer. A SAHPRA Authorised Representative, however, is a designated natural person based in South Africa who fulfils specific responsibilities associated with a medical device establishment licence.

Verion Medical provides local regulatory representation.
Medical device manufacturers and relevant licence holders must assess incidents against SAHPRA’s medical device vigilance reporting requirements. Reportability depends on factors including the nature and seriousness of the event, its relationship to the device and the potential risk to patients or users.

Verion Medical supports adverse-event assessments, regulatory reporting preparation and follow-up activities in accordance with the applicable SAHPRA medical device vigilance guideline.
Post-market surveillance is the systematic collection and evaluation of information about a medical device’s safety and performance after it has entered the market. It may include complaint trends, product performance data, risk reviews and post-market clinical follow-up activities.

Medical device vigilance focuses on identifying, assessing and reporting relevant adverse events and safety concerns. Verion Medical assists manufacturers and licence holders with both activities as part of ongoing regulatory compliance.
Changes to a medical device’s intended purpose, design, performance, labelling or manufacturing arrangements may affect its regulatory status and compliance obligations.

Not every change requires a new submission, but the regulatory implications should be assessed and documented. Verion Medical assists with product lifecycle change assessments and determining whether updates, notifications or additional regulatory actions are necessary under applicable SAHPRA requirements.
Clinical evaluation considers available clinical evidence to establish whether a medical device achieves its intended purpose and meets applicable safety and performance requirements.

A clinical investigation may be necessary where existing evidence is insufficient to support the device’s safety or clinical performance, subject to the relevant regulatory requirements. Verion Medical supports regulatory assessments of clinical evidence requirements and the appropriate pathway for further evaluation or investigation.

Our Thinking

News & Insights

Explore Our Services

Related Medical Device & IVD Services

Medical Device & IVD RegistrationImport, Export & Distribution
Medical Device Establishment LicensingSales & Market Development
ISO 13485 & Quality Management SystemsIVD Regulatory Support

Partner With Us

Understand the compliance implications before your next product or operational change.

Request a Regulatory Assessment