International – Emergo by UL Regulatory Recap: Global Trends November 2018

This is our second installment of global medical device regulatory updates and observations related to global trends. In the past few months (July through November 2018), we have observed data to support several global trends. We could wax philosophical on what constitutes a trend, though suffice it to say, our professional judgement has identified the following themes:

  • Initiatives that enhance device tracking and traceability,
  • The increasing activity of the Medical Device Single Audit Program or MDSAP (in spite of Health Canada’s newly announced flexibility), and
  • Proposals to simplify the regulatory process for the lowest risk medical devices.

The IMDRF continues to foster harmonization among the medical device regulators, and in this context sets the framework for many of these initiatives.

Global Post-Market Surveillance (PMS): Device traceability and tracking

Globally there continues to be an interest in collection of total product lifecycle data, and in digital and regulatory initiatives that facilitate data collection on explicit devices supplied to the market.

  • IMDRF: The IMDRF published three draft UDI documents (7/12/2018) N48, N53, and N54. The consultation of these documents closed in mid-October. This represents significant efforts made by the IMDRF as N54 is a tome of a draft UDI System Application Guide.
  • EU: In this period, the Medical Device Coordination Group (MDCG) released five guidance documentson UDI.
  • China NMPA: We had previously reported that the CFDA was to be renamed the CDA. Our tea leaves were inaccurate, and the moniker adopted by the regulators was actually National Medical Products Administration (NMPA). The NMPA  has released a revised UDI document (link in Chinese) for consultation. Again, consultation has been closed though this further advances the countries’ interest in implementing a UDI system for medical devices. Generally related to PMS, the NMPA has announced an interest in data on total product life cycle and PMS.
  • Brazil ANVISA: Related to the ANVISA National Implant Registry (RNI),  RDC 232/2018 (links in Portuguese) was promulgated to require GS1 or HIBCC barcodes  on labels of coronary stents and hip and knee prostheses, effective June 2020.


Our discussion from our last blog post, doesn’t waiver: Regulators are assiduously working to implement systems for device traceability (UDI). This trend will only continue to develop as other regulators adopt these initiatives.


Interest in the Medical Device Single Audit Program (MDSAP) strengthens (from both regulators and medical device manufacturers), enough to warrant a separate section in our blog this time. Our experience suggests there is a four-to-six- month delay in receiving an issued MDSAP certificate, though we continue to observe more clients interested in securing a MDSAP certificate. The US FDA publishes and maintains a list of the Auditing Organizations (AOs)  authorized and recognized to conduct MDSAP Audits. ANVISA, as required by Brazilian legislation, continues to publish in its official DOU AOs that have been officially recognized…