(1) DITTA activity
In Fiscal 2013, we dispatched our representatives to the following IMDRF meetings as DITTA. We collected the information and submitted our opinion at the meetings.
IMDRF Brussels meeting (November 12-14, 2013)
IMDRF San Francisco meeting (March 25-27, 2014)
During the Brussels meeting, we held a workshop on the themes of Software as a Medical Device (SaMD) and the Medical Device Single Audit Program (MDSAP). We invited administrative officials as a speaker. We joined the DITTA task forces for Medical Software, Unique Device Identification (UDI), Medical Device Single Audit Program (MDSAP), Regulated Product Submission (RPS), Environment, Good Refurbishment Practice (GRP), and Standard.
(International Committee)
(2) Response to overseas laws and regulations
- FDA published the UDI guidance. We held a seminar to help the member companies understand it and start their preparations.
- With regard to the Medical Device Regulation in Europe, the European Commission draft was issued as a proposal in September 2012. The European Parliament draft was proposed in October 2013. We surveyed the situation as of March 2014, considering problems and future prospects.
- The Chinese regulatory authority issued the following notices. China Food and Drug Administration (CFDA) issued notice (No. 9) related to medical equipment re-registration. CFDA issued the notice (the revised draft) of the list of data required for medical equipment re-registration. We offered the related information to the member companies.
- We dispatched our representatives to the 18th annual meeting of the Asian Harmonization Working Party (AHWP) and the 17th Technical Committee Meeting (December 1-5, 2013). We surveyed the trends of the AHWP.
- China has six categories of medical devices. We submitted our opinion related to "6870 Medical Software", a new classification.
(International Committee) |
