The World Health Organization (WHO) is seeking input on its newly developed regulatory framework for medical devices and in vitro diagnostics (IVDs).
The framework, which establishes a common global model for regulating devices and IVDs and provides countries with a two-phased path to implementation, was released for public comment in May.
WHO began its work developing the framework in 2015 after the World Health Assembly (WHA) adopted Resolution WHA67.20, which called on WHO to "prioritize support for establishing and strengthening regional and subregional areas of regulation of health products that are the least developed."
Today, most countries have a national medicines regulatory authority and regulatory standards for pharmaceuticals. However, many developing countries still lack a regulatory system for medical devices and IVDs.
Transitioning to a fully functional regulatory system for devices is a massive undertaking and will require a different approach for each country.
"Many countries have neither the financial resource nor technical expertise to transition successfully from an unregulated market to a comprehensive medical devices law in a single programme," WHO writes.
The framework being proposed by WHO relies heavily on standards developed by the Global Harmonization Task Force (GHTF) and its successor the International Medical Device Regulators Forum (IMDRF).
Under the framework, WHO says that standards for medical devices should be based on, or at least reference, the GHTF lists of essential principles for medical devices and IVDs.
The framework also calls for a class-based system for regulating devices and IVDs, similar to ones used in the US and EU, that would place stricter requirements on devices as the level of risk to patients or users increases.
Figure A: Device Class
WHO also recommends that countries without a fully developed regulatory system conduct some form of batch testing or lot verification for the highest-risk class of IVDs.
Additionally, the framework places significant emphasis on establishing a mechanism for regulators to "rely upon, or recognize, the world products from trusted regulatory systems (scientific assessments, audit and inspection reports) or WHO prequalification."
|Figure B. Medical Device Regulatory Requirements|| |
|Conformity assessment element||Class A||Class B||Class C||Class D|| |
|Quality management system||Regulatory audit normally not required, except where assurance of sterility or of a measuring function is required.||The regulatory authority should have confidence that a current and appropriate QMS is in place or otherwise conduct a QMS audit prior to marketing authorization.||The regulatory authority should have confidence that a current and appropriate QMS is in place or otherwise conduct a QMS audit prior to marketing authorization.||The regulatory authority should have confidence that a current and appropriate QMS is in place or otherwise conduct a QMS audit prior to marketing authorization|| |
|Technical documentation||Pre-market submission normally not requested.||Not normally reviewed pre-market. The regulatory authority may request and conduct a premarket or post-marketing review sufficient to determine conformity to Essential Principles||The regulatory authority will undertake a review sufficient to determine conformity to Essential Principles, prior to the device being placed on the market.||The regulatory authority will undertake an in-depth review to determine conformity to Essential Principles, prior to the device being placed on the market.|| |
|Declaration of conformity||Submission normally not requested.||Review and verify compliance with requirements.||Review and verify compliance with requirements.||Review and verify compliance with requirements|| |
According to WHO, a mechanism for reliance or recognition of assessments done by other trusted regulators is especially useful for regulators in low-resource settings that might not have the capacity or resources to conduct an assessment for every device necessary for their country's health system.
WHO recommends that countries looking to build or refine their regulatory system for devices and IVDs implement new measures in a stepwise fashion based on priorities.
In order to determine what steps might be necessary to shore up a country's regulatory system for medical devices, WHO recommends conducting a gap analysis to answer questions such as:
- Are medical devices regulated at all?
- Are they currently regulated as medicines or some other product category?
- Is there a specific and sound legal foundation for regulation of medical devices?
Based on the gaps identified for each country, WHO recommends implementing a regulatory framework in a two-step process for each of the three areas of regulation: premarket, on the market and postmarket.
First, WHO says that countries should look to establish a basic level of regulatory controls and enforcement, such as establish a risk classification system, register manufacturing establishment and establish an adverse event reporting system.
Then, once the system has matured, the agency recommends expanding the system to include more advanced features, such as establishing a process to authorize local clinical trials, regulate advertising and promotion and require mandatory adverse event reporting by manufacturers.
WHO Global Model Regulatory Framework for Medical Devices Including IVDs