2019年 6月 5日
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:
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.
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.”
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.
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.
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.
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.
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.