PROCESSING AND APPROVALS FOR NEW AND RENEWAL APPLICATIONS

Processing and approval of applications submitted by manufacturers or local agents for the registration, licensing, or market authorization of Class I to IV Products, ensuring compliance with regulatory requirements and timely access to safe Medical Devices.

Conducting thorough reviews and evaluations of market authorization applications to assess the safety, efficacy, and quality of the registered products, based peer reviewed scientific data.

PROCESSING AND APPROVALS FOR VARIATION APPLICATIONS

Processing variation applications submitted by manufacturers or local agents seeking to make changes to registered products, including modifications to manufacturing processes, labelling, packaging, or indications for use.

Conducting thorough reviews and assessments of variation applications to evaluate the proposed changes and their potential impact on the safety, efficacy, and quality of the registered products.

REGISTRATION OF IMPORTERS OF MEDICAL DEVICES

Processing of registration applications submitted by importers of medical devices, ensuring compliance with regulatory requirements.

Conducting reviews and evaluations of registration applications to assess the importer’s compliance with regulatory standards, such as Good Distribution Practice (GDP) requirements.

COLLABORATIVE REGISTRATION PROCEDURE (CRP)

The Department grants market Authorization for medical devices through the WHO collaborative registration procedure (CRP) for accelerated registration of WHO pre-qualified Medical Devices to facilitate efficient and timely market access for Medical Devices while ensuring patient safety and product quality.

Conducting collaborative review processes with regulatory Authorities from other countries involved in the registration of Medical Devices. This involves sharing the submitted documentation and coordinating assessments to streamline the review process.

REGULATORY RELIANCE

The Department grants market Authorization for medical devices using reliance on regulatory decisions made by other Authorities. To facilitate this the Authority relies on well-resourced National Regulatory Authorities (NRA’s) to exchange information and data to support reliance on regulatory decisions. This may involve sharing scientific assessments, safety data, inspection reports, and other relevant information to ensure consistency in regulatory decisions.

The Department ensures timely responses to registration applications, including acknowledgment of receipt, requests for additional information or clarification, and final decisions on approval or rejection