July 2018 Global Medical Device Regulatory Trends: Traceability, Simplified Market Access
Regulatory Updates | Medical Devices
In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices.
Periodically, we review all the global regulatory updates and changes for global trends. These are Emergo’s observations, fueled only by review of regulatory current events (and perhaps a few large cups of coffee). And, our analysis and assessment of them. We should also acknowledge that the International Medical Device Regulators Forum (IMDRF) has been working diligently to foster harmonization among medical device regulators.
Global Post-Marketing Surveillance (PMS): Device traceability and tracking
As we all appreciate, globally there is an emphasis on collection of total product lifecycle data, and on digital and regulatory initiatives that facilitate data collection on explicit devices supplied to the market. These efforts include adoption of a global naming convention. This issue itself could be the topic of a dissertation.
Progress seems to be made to advance the Global Medical Device Nomenclature (GMDN) system as the global system (signaling success of the IMDRF and the GMDN Codes as part of global harmonization), even with a subscription required to access the codes. There has been much development the past six months.
In the GUDID, the FDA included the text descriptors of the GMDN Codes, though not the actual numbers. The European MDR had previously referred to GMDN Codes in their draft legislation, though this was removed upon publication of the MDR in May 2017. The Australian TGA has included GMDN Codes in their ARTG listings, though the regulator also accepts template terms for Class I medical devices.
The FDA had already exceeded most other regulators with the legislative requirements for UDI and GUDID. However, when GUDID Release 2.3.2 was launched, the FDA catapulted to star status. One of the changes was to include Premarket Approval (PMA) and 510(k) clearance numbers associated with the entries. To Emergo’s knowledge, this is the first time that explicit device models will be systematically associated with 510(k)s. No longer will US market applicants performing regulatory research on their competitors’ devices (or their own devices) wonder about the regulatory path of a particular device—this will now be documented.
The Medical Device Regulation (MDR) (EU) 2017/745, whose May 26, 2020 date of application is now two years closer, promulgates UDI and EUDAMED, the European versions of the US FDA UDI and GUDID. To this end, the EU COMM and MDCG have made progress with both. In line with Article 34(1), the EU COMM has shared the implementation plan for functional specifications of EUDAMED in advance of the database’s May 26, 2018 launch deadline. By April 2018, the EU welcomed both the EUDAMED test sessions for the actor registration module and EU UDI Work Group and MDCG guidance documents on UDI, as well as a future EU medical device nomenclature.
The CFDA (to be renamed the China Drug Administration, or CDA) has released guidance on UDI, based on the US FDA and the IMDRF. Further, recently proposed draft changes (link in Chinese) to State Order No. 650 state that the CFDA intends to develop a UDI system for the medical device market in China in the future.
Health Canada has announced that they intend to apply GMDN Codes to improve “access to medical devices information.” GMDN Codes will now be part of Medical Device Licenses. As Health Canada stated in their announcement, they are effectively endorsing the IMDRF’s recommendation. Health Canada now joins other regulators in requiring the use of GMDN Codes related to medical devices on their market.
ANVISA has introduced the National Implant Registry (RNI) (link in Portuguese). The online system will initially collect voluntary registration information on surgical procedures for hip and knee prostheses, and coronary stents. The RNI will eventually be compulsory for all health services in Brazil, and may also be expanded to include other implantable devices. So, yet another regulator-mandated program to collect device data.
As one notes from the above highlights, regulators are feverishly working to launch systems for device traceability. These systems require methods to identify the devices, UDI and nomenclature, and there has been global development with adoption of UDI and GMDN Codes. There is also the important concept of compatibility among the regulators’ sites, and the IMDRF is helping with some of these efforts.
Last, while not discussed, interest in MDSAP appears to be strengthening (from both regulators and medical device manufacturers). The FDA recently proposed adoption of ISO 13485:2016 in place of current Quality System Regulations (21 CFR 820), and data from ANVISA presented at Hospitalar in May 2018 confirmed an increase in the number of companies using MDSAP to obtain Brazilian Good Manufacturing Practices (BGMP) approval.
Simplification of the regulatory process for the lowest-risk medical devices
Regulators generally develop a regulatory system where requirements are proportionate to the risk of the medical device. The US FDA and the EU regulators advocated regulatory systems where the lowest-risk medical devices have largely depended on a notification system (Class I and Class I self-certified, respectively). There are of course other countries’ regulatory regimes that implement analogous systems as well.
Emergo consultants have observed that some regulators initially promulgate their nascent systems with rigorous requirements for even the lowest-risk medical devices. As experience and confidence in the function of the system waxes, the system evolves. As noted in our examples, the lowest class of medical devices now (or will now) have a significantly simplified regulatory process.
ANVISA has released Public Consultation No. 528 of 2018 (link in Portuguese) on a proposed regulatory process change for Class I devices (including IVDs) from Cadastro registration to a simple notification. There is a 60-day comment period, and this revision to the regulatory system (Class I simplified notification, Cadastro, Registro) will align with the US FDA’s essentially three-tier system notification: Class I, 510(k), PMA.
Saudi Arabia SFDA
The SFDA added a Medical Device National Register (MDNR) (link in Arabic) regulatory process in Q4 of 2017, for Class I non-sterile, non-measuring devices. Further to this, there is now SFDA guidance from April 2018 on the MDNR route and the “Direct MDNR medical devices listing path,” which doesn’t require authorization from a GHTF founding member.
Major updates to Health Products (Medical Devices) Regulations 2010 (June 2018) (implemented all amendments proposed in February 2018) included exempting all Class A devices (sterile and non-sterile) from registration. Importers are now required to list all Class A devices on the HSA Class A database.
These developments align the risk of the medical device with regulatory requirements, and Emergo believes that these types of developments help make regulatory systems more efficient. These diminished regulatory requirements potentially also heighten the importance of PMS systems, so even with simplified regulatory requirements for the lowest risk medical devices, PMS data is still reviewed and device information tracked.
Evangeline Loh, Ph.D., RAC is Global Regulatory Manager at Emergo.