Regulatory reliance should accelerate access—not dilute accountability.
Regulatory reliance can reduce duplicated assessment and help health systems use scarce expertise more effectively. For diagnostic manufacturers, however, reliance is not a passport, an automatic registration or permission to reuse evidence without control. It works only when the product version, evidence, manufacturing site and local requirements remain traceable.
On 14 July 2026, WHO published its first transitional WHO Listed Authorities list for medical devices. The document identifies 12 national or regional regulatory authorities or networks whose listed scope includes medical devices and in vitro diagnostics. WHO describes the arrangement as time-limited and intended to support regulatory reliance while the permanent medical-device WLA pathway is finalised.
Reliance is cooperation, not delegation of responsibility
WHO defines the practical value of reliance as the ability of one regulator to use, where appropriate, assessments, inspections or decisions produced by another authority. The relying authority still owns its national decision. That distinction matters: a reference assessment can reduce duplication, but it does not remove local legal requirements, public-health priorities or the regulator's responsibility to decide whether a product is appropriate for its market.
The technical list also states that the ultimate decision on how to use the tWLA-MD list belongs to users such as regulatory authorities and procurement agencies. It notes that the precise scope of each transitional designation will be further defined. A transitional designation should therefore not be presented as permanent WLA status or as a universal approval route.
What the 2026 IVD pathway adds
WHO's revised IVD procedure, effective from 1 January 2026, separates performance evaluation from prequalification assessment. For IVD categories that require it, performance evaluation is a prerequisite. WHO states that a full prequalification assessment includes product-dossier review, manufacturing-site inspection and labelling review; an abridged assessment may use prior work by a recognised regulatory authority when the applicable conditions are met.
This architecture makes the evidence chain visible. Independent performance evaluation, dossier evidence, manufacturing controls and labelling remain distinct workstreams. Reliance may change how evidence is reviewed, but it does not erase the need to show which product was evaluated, where it is made, how changes are controlled and whether the submitted labelling matches the intended use.
The manufacturer's practical evidence map
Vision interpretation: a reliance-ready submission should be built as a controlled map rather than a collection of certificates. Before entering a new market, the manufacturer and local partner should be able to answer six questions:
- Reference decision: which authority assessed the device, under which legal route and for which intended use?
- Product identity: is the submitted configuration the same device, assay version, software version, specimen claim and manufacturing site?
- Evidence scope: which analytical, clinical, stability, usability and operational data support the exact claims?
- Gap analysis: what country-specific language, labelling, performance, vigilance, importer or local-representative requirements remain?
- Change control: how will design, supplier, site, software and labelling changes be evaluated across every affected registration?
- Post-market accountability: who receives complaints, investigates signals, reports incidents and coordinates field action?
Why this matters for localisation
A production transfer can create a new regulatory question even when the assay design is unchanged. A different manufacturing site, local raw-material source, packaging configuration or release laboratory may affect the evidence and notifications required by each authority. Localisation planning should therefore begin with product-version control and regulatory comparability—not after equipment installation.
That conclusion aligns with WHO's July 2026 account of the Private Sector Engagement Forum on local manufacturing. WHO reported that sustainable production depends on an ecosystem of quality systems, regulatory capacity, skilled people, supplier networks, financing and predictable demand—not production facilities alone.
The Vision Biotechnology response lens
Vision Biotechnology views regulatory reliance as an opportunity to design one disciplined evidence core that can support multiple authorised pathways without pretending those pathways are identical. In practice, that means maintaining a controlled product master, mapping claims to evidence, documenting manufacturing-site comparability, aligning quality agreements with local responsibilities and preparing country-specific gap assessments before submission.
For localisation projects, the same discipline should extend through technology transfer, training, process verification, lot release, stability oversight, complaint handling and regulatory change management. The goal is not to make a local factory look equivalent on paper. It is to demonstrate, through controlled evidence, which processes and responsibilities are equivalent and which require additional verification.
Use regulatory reliance to remove unnecessary duplication, never to hide differences. Build a traceable bridge between the reference assessment, the exact submitted device, the active manufacturing system and the local authority's requirements.
Primary sources
This article separates WHO-published information from Vision Biotechnology interpretation. It provides general regulatory and quality-system information; it is not legal advice, a market authorisation, a procurement recommendation or a claim about any specific Vision product. Applicable national requirements and authority decisions remain controlling.