Understanding Medical Device Registration and Adverse Event Reporting in New Zealand

Regulatory Authority

Medicines and Medical Device Safety Authority (MEDSAFE)

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.

Medsafe is responsible for administering the Medicines Act 1981 and Regulations 1984.
Enquires relating to pharmacy licensing and the Misuse of Drugs Regulations 1977 should be referred to Medicines Control officers

Link for Regulatory Authority

https://www.medsafe.govt.nz/index.asp

Local Regulation

• Medicines Act 1981
• Medicines Regulation 1984
• Medicines (Database of Medical Devices) Regulations 2003

Classification of Medical Devices

Listing or Registration Requirements

• Medical Device registration is processed via the WAND (Web Assisted Notification of Devices) database
• Determine the Device Classification
• Appoint an Authorized Representative
• Determine the product description as per the GMDN system
• Premarket approval of medical devices is NOT necessary. However, the product must be listed on WAND within 30 days of commercialization 

Documents Required for Registration

• Application on the letterhead of the applicant
• Completed appropriate form
• Declaration of Conformity (DoC)
• EC certificates for medical devices in question
• EN ISO 13485, etc.
• Free sale Certificate
• Insurance policy
• Statement by the manufacturer to provide technical file for a specific medical device, upon the request of the Institute
• Evidence on registration of a manufacturer in the Register of the Institute
• Labelling of outer and inner packaging of a medical device
• Instruction manual for a medical device

Registration Timeline

Approval timeline within 30 days of commercialization.

Registration Fee

No Direct Fee

License Validity

Does not Expire

Special Labelling Requirements

The Medicines Regulations 1984 establish minimum requirements for labelling of medical devices in New Zealand. Medical devices are expected to be labelled in accordance with international best practice.

Safety Information

Recall and Non-Recall Actions

Safety related actions taken by manufacturers and suppliers to address issues affecting products in the market are called recall and non-recall actions. These should be conducted in consultation with Medsafe according to the New Zealand Medicines and Medical Devices Recall Code.

• Recall Action Classification

• Responsibilities of Sponsors

Sponsors are responsible for identifying potential issues with their products, assessing the risks of any identified hazards, and mitigating those risks. In addition, sponsors and local manufacturers are responsible for maintaining records and establishing procedures which will assist in facilitating a recall action should such action become necessary. 

Sponsors should have access to staff with the required knowledge and expertise of the products and the regulatory process to affect a recall action.

• Recall Preparation and Planning

Every sponsor should have in place a written recall procedure that describes how a recall action will be initiated and carried out and should ensure that relevant staff members are appropriately trained in the procedure. Detailed requirements are to be listed in the procedure and must include requirements which correspond to the agreed recall action strategy and reporting requirements.

• Advising Medsafe

Sponsors should discuss the issue with Medsafe prior to initiating any recall or non-recall action.  Medsafe should be informed as soon as possible and advised of the proposed actions for New Zealand.

• Drafting a recall action notice

As the legal representative of the manufacturer in New Zealand, the sponsor must issue a recall action notice to their customers about the issue. The notice must be clear and concise and comply with the Recall Code.  The draft recall notice must be reviewed and agreed to by Medsafe before it is distributed to the affected parties.

• Conducting the recall action

Conducting a recall action involves; informing the respective persons / organisations (health care professionals, patients, hospitals, retailers, wholesalers, or distributors as appropriate), monitoring the effectiveness of the recall action, and implementing the communication strategy.

• Reporting to Medsafe

The sponsor should provide Medsafe with progress reports on the implementation of the recall action, the response rates, the investigation into the issue and any corrective and preventive actions planned or implemented.

• Closure of a recall action

At the conclusion of the recall action the sponsor is to provide a final report summarising the action taken, its causes, manufacturer’s actions to prevent a recurrence, status of the recalled product, or confirmation the product correction has been applied to all affected units.

Adverse Event Reporting

Medical device issues can be reported by patients, caregivers, healthcare professionals, and suppliers. If an incident has occurred and there is concern about the device’s safety or use, anyone can file an adverse event report. The appropriate form can be selected from the table below:

• Reporting Timelines

• Medsafe Process

Medsafe reviews all adverse events, considering safety and quality issues. If a trend is identified, evaluation and analysis may be conducted to investigate the relationship between the device and the adverse event. Further information may be requested from the reporter and/or the device supplier, and Medsafe may contact overseas regulatory agencies to confirm similar reports.

Medsafe can take various actions in response to safety concerns, such as requesting further information from the medical device supplier, informing healthcare professionals and consumers through communications on the Medsafe website and Prescriber Update, issuing advice or alerts, and requesting the supplier to provide corrective action.

Details from each report are entered into a secure database, which is available for analysis by Medsafe staff to identify possible trends associated with a particular device or group of devices. Medsafe may publish some information on the reporting form, but this data will not include names or other identifiable details of the person who made the report or who the report was about.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk