When is a manufacturer's authorisation letter needed?

UNDP lists it, as applicable, among the requirements for suppliers, to confirm that the bidder is authorized by the manufacturer; WHO (2024) asks for it for a distribution agent, if applicable.

Can a plant be serviced by someone the manufacturer has not trained?

Global Fund warranty contract guidelines (2024) list maintenance by hospital staff or others not trained by the manufacturer among the conditions that void the warranty.

What is a manufacturer's authorisation in an oxygen plant tender?

Q: What is a manufacturer's authorisation in an oxygen plant tender, and which buyers ask for it?

In UNDP procurement (REQ-OXY-001, 2025), a manufacturer's authorisation is a letter or certificate from the manufacturer confirming that the bidder is authorised to supply its oxygen plant, as applicable, current and valid at submission; WHO's 2024 specifications list a letter of authorization for the distribution agent, if applicable.

What is a manufacturer's authorisation in an oxygen plant tender, and which buyers ask for it?

What the procurement documents ask for

Document	What it asks
UNDP, REQ-OXY-001 (effective 1 January 2025), Annex I	Under requirements for the supplier: name and address; a quality management system certificate and a good distribution and storage practice certificate or equivalent; and a letter or certificate of authorization from the manufacturer confirming that the bidder is authorized for provisions, as applicable. Copies of all documents shall be current and valid at the time of submission, and the supplier is responsible for checking certificate expiry
WHO, Technical specifications for health facility based medical oxygen systems (December 2024)	Documentation includes a letter of authorization for the distribution agent (if applicable); the after-sales service agreement is suggested with a qualified provider authorized by the manufacturer; it asks for a lifespan of at least 10 years guaranteed by the manufacturer, and for spare parts availability of at least 10 years from acceptance
WHO, Technical specifications for PSA oxygen plants, interim guidance (8 June 2020), superseded by the 2024 specifications	Life span guaranteed by a letter from the manufacturer, not only from the authorised distributor; contact details of the manufacturer, authorized distributors (if applicable) and local service agent; advanced maintenance by a third-party trained technician authorized by the manufacturer
Global Fund, Quality Assurance Policy for Medical Devices and Core PPE (amended 15 November 2023)	The manufacturer and manufacturing site of the medical devices disclosed in all applicable solicitation and procurement-related documentation

UNDP also says that the bidder shall provide clarifications if proof or certificates that are mandatory at the time of submission are not available, and that bidders that are not manufacturers are expected to comply with all the requirements of ISO 13485 for medical device products. See what certificates a PSA supplier should provide.

Where the manufacturer's role shows up after award

Installation and training: UNDP asks for the plant to be installed with manufacturer-certified competent personnel and for training to be conducted by certified trainers from the manufacturer. WHO (2024) says that, for service contracts, certifications of trainers by the original manufacturer, and the content and modality of delivery, should be agreed on by all parties before engaging in a contract.
Warranty: Global Fund warranty contract guidelines (20 May 2024), which list what a warranty contract for an oxygen plant should include, name two of the conditions that void the warranty as maintenance by hospital staff or others not trained by the manufacturer, and modifications, alterations or repairs by unapproved personnel.
Spare parts: Global Fund guidance on spare parts (25 September 2025) says parts can be bought directly from the manufacturer or through an authorized distributor, not from an unauthorized supplier, because purchasing from unauthorized suppliers may void the warranty.

Ultra Controlo

Ultra Controlo designs and manufactures its systems, including ULTRAOX oxygen plants, in Portugal in its own factories, and is certified to ISO 13485:2016; see is Ultra Controlo a manufacturer or a distributor.