Hong Kong Offers Tips on Listing Medical Devices
Manufacturers of medical devices approved for marketing in one or more of the Global Harmonization Task Force’s founding member jurisdictions by Dec. 31, 2004, may skip a key requirement for listing their products in Hong Kong, a recent directive from the Medical Device Control Office says.
Applicants whose products received authorization by that date in the U.S., EU, Canada, Japan or Australia are not required to complete a form MD-CCL: Essential Principles Conformity Checklist, according to the notice.
Firms that previously have prepared the Essential Requirements Checklist in accordance with the EU’s Medical Devices Directives and “have sufficient evidence that their products also comply with the [Medical Device Administrative Control System] MDACS requirements” may submit the checklist and a declaration of conformity in place of the MD-CCL, the notice says.
Certificates from recognized conformity assessment bodies in other jurisdictions must demonstrate compliance with the MDACS requirements for conformity assessment. Those applications should include the MD-CCL, a risk analysis summary and clinical trial data.“Supplementary Notes for Submitting Applications for Listing Medical Devices Under the Medical Device Administrative Control System” is available at www.mdco.gov.hk/english/mdacs/mdacs_gn/files/supp_notes_20080611.pdf.