International Benchmarks both in Health and GRPs are critical elements to consider while working towards advancing the Regulatory Convergence agenda, as well as to prevent the creation of Technical Barriers to Trade.
A wealth of resources to learn and apply these benchmarks are available in a condensed form in here.
World Health Organization
The WHO has four principle international benchmark documents constituing the global consensus regarding medical device regulatory frameworks and guidance for medical device national regulatory authorities.
World Trade Organization
The WTO has one principle international benchmark document constituting the global consensus and treaty-based legal obligations regarding regulatory processes applicable to medical device regulatory frameworks medical device national regulatory authorities.
Technical Barriers to Trade Agreement (TBT)
International Medical Device Regulators Forum (IMDRF)
The IMDRF maintains dozens of international benchmark documents constituting the global consensus regarding medical device regulatory frameworks and guidance for medical device national regulatory authorities. The following IMDRF documents comprise the core IMDRF guidance, beginning with the “N47 – Essential Principles”.
International Medical Device Regulators Forum (IMDRF) documents (all), including:
Medical Device Single Audit Program (MDSAP)
The MDSAP is a global approach to auditing and monitoring the manufacturing of medical devices. The MDSAP allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
There are over 200 international standards from standards developing organizations (SDOs) that are used by medical device regulatory authorities and industry for regulatory purposes. These documents are developed in open processes consistent with the requirements of the World Trade Organization, are updated at pace with technological changes and constitute the global consensus regarding medical device technical requirements.
A compendium of these standards is included within the following two standards from the International Organization for Standardization (ISO):
These documents can be obtained via the 168 ISO member national standards bodies, or for MDRC project countries, through the MDRC.