MDSAP Implementation on Target for 2017, FDA Says

January 22, 2016

The International Medical Device Regulators Forum’s single-audit program remains on schedule for full implementation in 2017, officials say.

Applications for participation in the Medical Device Single Audit Program have been received from 12 of 13 eligible auditing organizations. Five organizations currently are authorized to conduct MDSAP audits, CDRH spokesman Eric Pahon tells IDDM.

MDSAP was developed so that a single audit, performed by an authorized organization, meets the quality management system requirements of multiple regulatory agencies, derived from ISO 13485:2003. In December, the FDA announced it will terminate its ISO 13485:2003 Voluntary Audit Report Pilot program effective March 31, to help manufacturers transition over to the MDSAP (IDDM, Dec. 31, 2015).

Meanwhile, Brazil’s ANVISA published a resolution earlier this month listing TÜV SÜD America as an authorized company to perform auditing reports.

ANVISA will accept the MDSAP audit reports as a substitute for routine agency inspections. The validity of ANVISA’s authorization expires on Dec. 31, explains Roberto Rodrigues, an attorney with Licks Advogados in Rio de Janeiro. In December, ANVISA recognized BSI Group as an accredited auditor under MDSAP.

Canada still is planning to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with QMS requirements.

MDSAP will replace the current Canadian Medical Devices Conformity Assessment System program, even in situations when a manufacturer intends to sell only in Canada, according to a notice issued by Health Canada in December.

Effective Jan. 1, 2017, Health Canada will accept certificates issued under both CMDCAS and MDSAP. However, only MDSAP certificates will be accepted starting in 2019.

MDSAP pilot full members are the U.S., Australia, Brazil, Canada and Japan.

Read ANVISA’s resolution here: www.fdanews.com/01-16-Anvisa-RE80.pdf. Health Canada’s notice is here: www.fdanews.com/01-16-Canada-Notice.pdf. — Jonathon Shacat