Determine product classification: Follow the classification principles established by the GHTF; the regulatory basis is the Medicines (Medical Devices Database) Regulations 2003
Designate a New Zealand sponsor: Select a New Zealand-based responsible party (Sponsor) that meets regulatory requirements to serve as the entity responsible for product compliance in the New Zealand market. Additionally, a manufacturer information registration process is required.
Compilation of Technical Documentation: Organize and compile a complete technical dossier. Key components include: product description and specifications, manufacturing information, a list of applicable industry standards, documentation demonstrating compliance with General Safety and Performance Requirements (GSPR), risk management documentation, clinical evaluation information, and statutory documents such as the Declaration of Conformity (DOC).
Submission of Registration Application: Upload the complete set of documents to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and submit the registration application.
Review of Application Completeness: The Sponsor conducts a formal review of the submitted application materials to confirm their completeness and compliance.
Supplemental Documentation (if applicable): If the review identifies missing or non-compliant information, relevant materials must be submitted in response to official feedback.
Technical File Evaluation: The regulatory authority conducts a comprehensive evaluation of the product’s technical specifications, safety, and efficacy, covering multiple professional dimensions such as medical device design principles, performance metrics, safety risk assessment, and ergonomics.
Clinical Evaluation: Medsafe reviews clinical trial protocols, results reports, and data analyses to verify the product’s clinical safety and efficacy.
Authorization Assessment: The regulatory authority evaluates the product’s authorization qualifications and technical support capabilities to ensure that market supply and post-market services meet compliance requirements.
Issuance of Review Results: Medsafe makes an approval decision based on all submitted materials and assessment conclusions; the outcome is either approval or rejection of registration.
Obtaining a WAND Registration Number and Maintaining Compliance: Upon approval of registration, the company will receive a WAND registration number; subsequently, it must submit annual product updates and compliance review reports to maintain the product’s registration.
Medsafe typically takes about one month to complete the registration of a medical device after receiving all necessary documents and information.
The registration timeline may vary depending on the product type, complexity, and other factors.
Medsafe currently does not charge any official fees.
Labeling Requirements
Under the Medicines Act 1984, medical device labeling must comply with international best practice standards. The Global Harmonization Task Force (GHTF) is an organization composed of major regulatory authorities and industry representatives dedicated to developing guidelines for the harmonization of international medical device regulatory practices. For detailed guidance documents, please consult Wiselink.
