The FDA’s Center for Devices and Radiological Health (CDRH) has opened a webpage to facilitate industry’s use of regulatory reliance, which allows national regulatory authorities to make more efficient use of their resources. Reliance differs significantly from harmonization, however, a distinction CDRH is keen to make.
The announcement states that the medical device industry has become increasingly globalized and that regulatory
authorities may be expending resources less than optimally in such an environment. CDRH describes regulatory reliance as a process in which one regulator takes into account the assessments performed by its counterpart in another nation. The regulatory agency that practices reliance does not forgo its autonomy, but seeks to avail itself of the regulatory activities of a trusted counterpart authority.
In contrast, harmonization is the process in which technical guidelines are adopted more or less in their entirety across national jurisdictions. Regulatory convergence lands in the middle between reliance and convergence[AK1] , consisting of a gradual process of alignment via adoption of internationally recognized standards. Convergence can also be achieved by adoption of domestic regulatory mechanisms that share the underlying principles in use by other regulators.
Reliance is useful for several reasons, including that it allows resource-strapped regulatory entities to focus their efforts on high-priority areas, such as matters that present an opportunity to impact public health in that nation. There are limitations with regard to reliance, however, such as when two regulators have applied a different risk classification to a specific device type. CDRH said there may be instances in which national laws do not allow the use of regulatory reliance, although no examples are provided.
The practice of regulatory reliance is described in some detail in a 2026 guidebook by the International Medical Device Regulators Forum (IMDRF). The IMDRF document states that reliance can be practiced by partial or wholesale adoption of the reference regulator’s decision, for instance in the context of a premarket application.
Another mechanism available to regulatory agencies is mutual recognition of premarket application approvals and clearances as well as inspections of drug and medical device manufacturing facilities. Mutual recognition agreements may be limited to low- and moderate-risk medical devices, such as the June 2025 agreement between the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia’s Therapeutic Goods Administration (TGA).
An alternative to reliance for inspections is the Medical Device Single Audit Program (MDSAP), a program of sufficient importance to merit its own website. Under the MDSAP program, inspections conducted by one regulatory entity may be recognized by another regulatory agency taking part in the program.
At present, five national regulatory authorities take an active role in the MDSAP program, including the FDA, TGA, Health Canada, the Brazilian Health Regulatory Authority (ANVISA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). MHRA and the European Union are official observers, while another nine regulatory agencies take part as affiliate members.
However, active participants may not recognize MDSAP audits for all purposes. One example of this is the CDRH pre-approval inspection for PMA devices. CDRH also does not allow MDSAP audits to serve in lieu of for-cause inspections conducted as a response to a device recall or a series of adverse events. However, MDSAP audits can be valuable in that they are conducted under ISO 13485, the internationally recognized quality management standard that is practiced by a large number of regulatory agencies across the globe.
[AK1]“harmonization”?
Last updated on October 9, 2026