Cleanroom contractor in New Zealand: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your plant

Medsafe says manufacturers and packers with premises in New Zealand must hold a current licence to manufacture or pack medicines. The licence must be issued for the site and the type of operation before manufacture for distribution can start (Medsafe, Manufacture of medicines guideline, edition 5.4, November 2024).

Medsafe uses the New Zealand Code of GMP to decide licence applications under the Medicines Act 1981 and the Medicines Regulations 1984. The Code is aligned with the PIC/S Guide, and Medsafe's page, revised on 19 April 2021, gives the current edition as PE 009-14, effective 1 July 2018 (Medsafe). Ask the owner if Medsafe has updated it.

Who builds cleanrooms here

Companies that manufacture or pack medicines in New Zealand are the regulated buyers, because the licence is issued for the site before manufacture starts. Medsafe's guideline lists sterilisation sites and packers of the finished product among the sites that need GMP evidence, so a sterile or packing room is within scope. For overseas sites, Medsafe asks for current GMP certification with each application and, if acceptable evidence is missing, can audit the site at the applicant's request and expense. This reading comes from the Medsafe pages, not from market statistics.

What a foreign supplier must arrange

The Building (Building Product Information Requirements) Regulations 2022 apply to designated building products manufactured in or imported into New Zealand on or after 11 December 2023. Manufacturers and importers must publish a free product statement covering the product description, the scope and limits of use with reference to Building Code clauses, design, installation and maintenance requirements, and whether the product is subject to a warning or ban under section 26 of the Building Act 2004. The Ministry of Business, Innovation and Employment can issue corrective action or infringement notices, or prosecute (Simpson Grierson). Ask the owner's engineer whether the panels and doors are designated building products, and which New Zealand party acts as importer.

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the plant is new or existing, whether the rooms are sterile, and whether the owner holds a Medsafe licence for the site. Name the quality head who will deal with Medsafe.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• Writing a cleanroom URS: contents and testable wording
• How long does it take to build a cleanroom?
• Building a cleanroom inside an existing building
• How to choose a cleanroom contractor: questions and evidence
• Turnkey cleanroom contractor
• Room list builder

Sources

• Medsafe, Guidelines on the Regulation of Therapeutic Products in New Zealand: Manufacture of medicines, edition 5.4, November 2024
• Medsafe, New Zealand Code of GMP, Part 1 introduction (page revised 19 April 2021; checked 1 November 2026)
• Simpson Grierson, New building regulations now in force (checked 1 November 2026)
• PIC/S, list of participating authorities (checked 1 November 2026)