In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified themes:

  • Initiatives that enhance device tracking and traceability,
  • The increasing activity of the Medical Device Single Audit Program or MDSAP (now that we’ve past Health Canada’s March deadline), and
  • Proposals to simplify the regulatory process for the lowest-risk medical devices.

We note the fervor of recent International Medical Device Regulators Forum (IMDRF) activity and initiatives: eight final guidance documents were published in March, representing four working groups. The IMDRF continues to set the framework for global harmonization.

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

Globally, initiatives to collect total product lifecycle data and to facilitate digitized data collection on explicit devices supplied to the market abound.

Interest continues to wax in the collection and interpretation of total product lifecycle data, and in the corresponding initiatives to foster data exchange. So much so that the US FDA announced the reorganization of the CDRH in mid-March along product lines and into “teams responsible for device oversight throughout the product’s development and commercialization.”

  • IMDRF: Three previously mentioned draft UDI documents have been finalized..  A document on the terms and codes for categorized Adverse Event Reporting, based on ISO 19218, was also finalized.
  • GMDN Agency: While not an April Fool’s joke, the GMDN Agency declared on April 1 that basic membership was complimentary. This was after news about the cooperation with the Eurasian Economic Commission. 
  • EU: The Medical Device Coordination Group (MDCG) continues to provide guidance on UDI. There are now also documents related to the publicly accessible database, Eudamed, including the timing of the Medical Device Regulation (MDR) (EU) 2017/745 requirements. The global nomenclature was revealed as the Italian CND (Classificazione Nazionale dei Dispositivi medici) (link in Italian). And, a vigilance form that makes IMDRF Medical device problem codes mandatory has been published.
  • Australia TGA:  In January, the TGA shared their proposed UDI system.  Their consultation proposal contained references to the IMDRF, US FDA, and EU MDR, replete with an AusUDID (UDI database) which would link with the ARTG listings.
  • Japan PMDA: In January, we learned that the PMDA had finally posted the Japanese Medical Device Nomenclature (JMDN) Codes to their website in English.
  • Taiwan TFDA: Specification for UDI based on IMDRF (published in 2018).

Discussion

Our position from our last blog post doesn’t waiver: Regulators are assiduously working to implement systems for device traceability (UDI). The Australian TGA has proposed a system now, as well. Health Canada declared via email correspondence that they are monitoring UDI developments and intend to update Canadians later in 2019. In Taiwan, the TFDA has a UDI system, though voluntary. The South Korean MFDS has issued guidance to support manufacturers of Class IV devices with their impending UDI deadline of July 1, 2019. This trend will only continue to develop as other regulators announce and adopt these initiatives.

For nomenclature enthusiasts, it was a pleasant surprise that the Europeans selected the Italian CND. (Albeit the CND is linked to GMDN Codes.) And, the JMDN Codes, based on GMDN Codes (2003), are finally translated in English and accessible to more than the Japan Association for the Advancement of Medical Equipment (JAAME) members. It is also exciting that the EU has implemented the IMDRF codes in their New Incident Report form (version 7.1).

We note the potential with these global nomenclatures--but continue to advocate for one singular system--and clearly the opportunities if these IMDRF vigilance problem codes are adapted as published by the IMDRF.

ISO 13485:2016 and MDSAP

Advances with ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) from both regulators and medical device manufacturers further strengthen the concept of a global quality management system.

  • Brazil ANVISA: ANVISA shared the status of MDSAP use at Hospitalar (May 2019) and announced many proposed changes. ANVISA RDC 183/2017 will be revised to more clearly specify when certification will be granted for desktop certification, and that Brazilian Good Manufacturing Practice (BGMP) based on MDSAP will be valid for four years.
  • South Korea MFDS: MFDS Notice No. 2019-25  finalized the revision of K-GMP requirements to align with ISO 13485:2016, effective 1 July 1, 2019.
  • India CDSCO: At the 82nd Drugs Technical Advisory Board (DTAB) Meeting, there was agreement to align QMS requirements with ISO 13485:2016 (currently :2003).

Discussion

ANVISA stated that 4,415 companies now participate in the MDSAP program. In 2019 alone, 40% of the BGMP certificates issued were through MDSAP (123 BGMP certificates). These are noteworthy statistics, and the proposed changes to RDC 183/2017 GMP certificates for foreign establishments inspection program and administrative procedures will likely further encourage MDSAP use. The deadline for the Health Canada requirement for MDSAP has passed.

While we remain optimistically cautious, the momentum with endorsement of MDSAP from Health Canada and ANVISA is exciting.

Simplification of regulatory processes for lowest-risk medical devices

We have compiled several examples where lower-risk medical devices have a simplified regulatory process, or for which the entire regulatory process will be eased.

  • Brazil ANVISA: RDC No. 270/2019, and accompanying Guidance, announced the Class I notification route, effective May 1, 2019.
  • Ecuador ARCSA: Resolution ARCSA-DE-030-2018-JCGO, amends Resolution ARCSA-DE-026-2016-YMIH (regulation on registration and control of medical devices), with  a simplified route for Class I and II devices with registration in a recognized country (US/CAN/AUS/JP/SKR/EU).
  • Costa Rica Ministry of Health:  N° 41387-S  (September 2018) established that Class I devices no longer require registration.

Discussion

The FDA finalized classification of suitable accessories into Class I, effective May 13, 2019, and promised to publish another proposed list of Class I accessories. Brazil officially enacted another regulatory process for the lowest-risk devices (Class I notification pathway): on-line submissions, processed within 30 days, no expiration, and published by ANVISA. Ecuador developed an easier registration process for certain Class I and II devices, and Costa Rica has eliminated entirely the registration requirement for Class I devices.

The medical device sector continues to embrace and welcome all these programs, and particularly those that foster efficiency while permitting focus on seminal safety and performance aspects.

Evangeline Loh, Ph.D., RAC is Global Regulatory Manager at Emergo by UL.