Medsafe, the Ministry of Health and the Director-General

1. Key takeaways

Medical devices in New Zealand are managed by three actors. Medsafe is the business unit within the Ministry of Health responsible for medicines and device regulation; the Ministry of Health is the department recorded on legislation.govt.nz as administering the Medicines Act 1981, the Medicines Regulations 1984 and the Medicines (Database of Medical Devices) Regulations 2003; and the Director-General (the Director-General of Health) is the office-holder to whom the provisions confer powers, and the statutory counterparty to the Sponsor’s obligations.

Medsafe’s official legislation page states: Medsafe is responsible for administering the Medicines Act 1981 and the Medicines Regulation 1984. and Medsafe is responsible for administering the Medicines (Database of Medical Devices) Regulations 2003. Day-to-day administration, guidance and WAND operation rest with Medsafe; the statutory holder of the powers is chiefly the Director-General.

The Director-General’s key powers number four: under reg 4 of the 2003 Regulations, to ensure the database is established and maintained, correcting or adding information at any time; under Schedule 1(i), to declare classes of devices exempt by Gazette notice (the 2003 IVD exemption notice was made under this power); under s 38 of the Act, to issue evidence notices where a device may be unsafe; and under reg 50 of the 1984 Regulations, to order devices withdrawn from sale and require disposal or destruction. Alongside sits the ministerial s 37 prohibition notice, for periods not exceeding 1 year.

2. Legal basis

The table records each actor and matter against verified instruments and provisions.

3. Expert insights

Insight 1: Medsafe administers the instruments, but the provisions address powers to the Director-General. legislation.govt.nz marks the 2003 Regulations as Administered by Ministry of Health, and Medsafe’s own page claims administration; yet reg 4 reads, “The Director-General must ensure that a database… is established and maintained”. Operationally WAND is run by Medsafe and problem emails go to devices@health.govt.nz; legally the addressee remains the Director-General. In formal correspondence, address the Director-General of Health, or Medsafe as database maintainer acting for the Director-General, to avoid misnaming the counterparty.

Insight 2: The exemption power works by class declaration, not case-by-case approval. Schedule 1(i) empowers the Director-General to declare a whole device class exempt by Gazette notice. The exercised instance is the Exemption Medical Devices (In Vitro Diagnostic Devices) Notice (No. 1) 2003, made by the then Director-General, Dr Karen O. Poutasi, on 12 December 2003 under Schedule 1(i), in force from 1 January 2004, declaring devices commonly known as in vitro diagnostic devices to be an exempt class. (The Gazette publication date appears inconsistently across Medsafe pages; GRZAN records only the December 2003 making and the 1 January 2004 commencement.) The exemption power operates publicly, in batches and by class; companies cannot apply for individual exemptions.

Insight 3: The Director-General’s hard powers are the safety enquiry and the recall order. With no premarket approval, the regulator’s centre of gravity moves to the post-market phase. Section 38 empowers the Director-General, where there is reason to believe a device may be unsafe, to give written notice requiring evidence within 45 days; selling before the requirement is met offends s 38(8). Reg 50 of the 1984 Regulations further empowers the Director-General to order recalls from importers, manufacturers or sellers, requiring disposal or destruction and a statement of how and when compliance is intended. These two powers show why no review does not mean no regulation.

Insight 4: What Medsafe explicitly does not do is as important as what it does. Medsafe states on the WAND page that WAND is not an approval system and that notification does not mean Medsafe has assessed the device’s quality, safety, effectiveness or performance; it issues no rulings on risk classifications submitted by companies. Asking which class our product belongs to, or for confirmation of our classification, yields no official ruling; classification responsibility sits with the Sponsor and the manufacturer. This boundary shapes engagement: procedure and system-use questions are proper; requests for confirmation of technical judgements are not.

4. Practical recommendations

• Choose the counterpart by subject matter. WAND system use and adverse event reporting go to devices@health.govt.nz; matters involving record corrections, exempt classes, safety enquiries or recall orders are legally addressed to the Director-General, with Medsafe handling the practical communication. GRZAN recommends determining the counterparty before correspondence, so legal claims are not routed to a window without authority to decide them.
• Keep written records of all Medsafe communication. In a recall, the Sponsor must discuss the matter with Medsafe in advance, issue the recall notice as the manufacturer’s legal representative in New Zealand, obtain Medsafe’s agreement to the draft notice, then submit progress and final reports (under the New Zealand Medicines and Medical Devices Recall Code, current version in force from 1 December 2015). File every email exchange, draft and agreement record as evidence of duty performance.
• Put the Director-General’s powers into the risk contingency plan. The plan should cover three triggers: the s 38 safety evidence notice (a 45 day window), the reg 50 recall order (stating how and when compliance will occur, with written notice after compliance), and the s 37 ministerial prohibition notice (up to 1 year). Each scenario needs a named lead, an evidence owner and an agreed external line.
• Do not apply to Medsafe for classification rulings or approval confirmations. Classification bases should come from the manufacturer and be checked by the Sponsor against the Schedule 2 rules; external material must likewise avoid implied official endorsement (the reg 10 prohibited statements).
• Monitor change through two entry points. Version records on legislation.govt.nz and revision dates on Medsafe’s device pages. The current official version of the 2003 Regulations is 7 August 2020.

5. Verification checklist

• □ The administering department of the three instruments is the Ministry of Health, with day-to-day administration by Medsafe
• □ Formal correspondence is addressed to the Director-General of Health as the statute requires, or names Medsafe as database operator
• □ The Director-General’s four key powers are known: reg 4 (database), Schedule 1(i) (exempt classes), s 38 (safety evidence), reg 50 (recall orders)
• □ Exemptions operate by class plus Gazette notice, with no case-by-case application channel
• □ The making date of 12 December 2003 and commencement date of 1 January 2004 of the Exemption Medical Devices (In Vitro Diagnostic Devices) Notice (No. 1) 2003 are recorded
• □ No classification ruling or approval confirmation has been requested from Medsafe; classification bases are archived
• □ The contact address devices@health.govt.nz is in the internal contact table
• □ Risk plans for the s 38 evidence notice, the reg 50 recall order and the s 37 prohibition notice have named owners

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team manages Medsafe sponsor obligations and WAND entry requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com