Worldwide Medical Device Regulatory Updates

Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.

According to the Saudi Food & Drug Authority’s (SFDA) website as well as email communication from BSI, foreign medical device manufacturers must provide the regulator with documents proving that their products are authorized to be sold in one or more Global Harmonization Task Force founding members—Australia, Canada, Europe, Japan or the US. Devices must also provide documentation showing compliance with MDIR requirements, after which the SFDA will issue marketing authorizations allowing manufacturers to begin or continue selling their products in the country.

New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding post-market surveillance requirements for pediatric products.

 The guidance stems from changes made to Section 522 of the FDA Amendments Act of 2007 that authorize the FDA to order postmarket surveillance periods of longer than 36 months for Class II and III devices with significant pediatric applications; 510(k) clearance or PMA approval of those devices would be contingent upon meeting those postmarket surveillance requirements.

The FDA emphasizes that section 522 postmarket surveillance requirements apply not only to devices labeled for pediatric use, but also devices with off-label pediatric applications. The agency may order postmarket surveillance studies of durations longer than 36 months in instances where a device’s impact on growth and development needs to be assessed.

The FDA’s Center for Devices and Radiological Health (CDRH) has the authority to require postmarket surveillance studies at any point in a device’s lifecycle. The guidance lists several examples of when in the pre- or post-market process the CDRH may order surveillance:

• To confirm the nature, severity or frequency of issues contained in adverse event reports or published literature
• To gain more experience with a change in the device’s use from hospital to home settings, or with new patient populations
• To address long-term or infrequent safety and effectiveness questions regarding implantable devices and other products that premarket testing does not adequately cover
• To better define a device’s problems stemming from unexpected adverse events after that device’s marketing has begun

In the event that the CDRH orders a manufacturer to conduct a postmarket surveillance study, the guidance lists key elements to include in a study plan, including device description and indications for use, study purpose and objectives, design, and timelines. Guidelines for submitting interim and final study reports, as well as content and formatting requirements, are also covered.

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications.

In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).

First, the FDA considers measures for effectiveness of devices. Under this category, reviewers measure the type, magnitude and probability of benefits provided by a device, as well as the duration of those benefits for the patient.

Second, the agency considers measures for safety of devices. These include device-related serious and non-serious adverse events, procedure-related or indirect harms stemming from the device under consideration, and probability and duration of harmful events. Risks from false-positive or false-negative results produced by diagnostic devices also fall under this category of factors.

Additional factors the FDA lists in the guidance include uncertainty in terms of reviewers’ ability to determine reasonable assurances of safety and effectiveness; characterization of the disease or condition a device is designed to diagnose or treat; patient tolerance for risk, which can be affected by issues such as disease severity and chronicity; availability of alternative treatments; use of risk mitigations such as warning labelsto minimize the likelihood of harmful events; and novelty of technology used in a particular device.

The guidance also includes examples of how FDA reviewers use multiple combinations of factors to evaluate benefits and risks of particular medical devices. The FDA has also provided a draft of a Worksheet for Benefit-Risk Determinations in order to maintain more consistency in the PMA process, especially for devices requiring reviews across different agency divisions. 

Mexico’s medical device regulator COFEPRIS is considering utilizing third-party reviewers (link in Spanish) to speed up submissions under the standard registration process.

In mid July, the regulator published a notice to interested companies to apply within 30 days for consideration to be designated third-party reviewers. Class I, II and III device registration submissions would be eligible for third-party review according to the notice.

Firms applying to serve as third-party reviewers for COFEPRIS must meet five general requirements.

First, application forms must be submitted to COFEPRIS within 30 days of the notice’s publication.

Second, applicants must be legally incorporated under Mexican law, or in the case of individuals, naturalized Mexican citizens.

Third, applicants bust provide written attestation under oath that their products, processes or services comply with Mexican Standard NMX-EC-17020-IMNC-2000.

Fourth, applicants should meet the requirements of Article 211, Section II of the Rules of Inputs for Health in terms of having the technical and financial resources—including liability insurance—to properly conduct third-party reviews and inspections.

Fifth, applicants must be under no direct influence of any manufacturer, importer or other party that could cause conflicts of interest regarding registration reviews.

Additional documentation requirements are listed in the COFEPRIS notice; an English translation (via Google) of the requirements is available here.

If COFEPRIS ultimately does implement a third-party review system for standard medical device registrations, the move would add additional efficiencies to the Mexican device registration process and further increase the market’s appeal to foreign manufacturers.