Hong Kong MDACS: Voluntary Listing

Is Hong Kong listing voluntary? For now, yes. But a new regulator, the CMPR, is being set up this year, and device legislation is planned. Today, the Medical Device Division runs MDACS. A Local Responsible Person in Hong Kong applies online. Class II to IV devices and Class B to D IVDs can be listed, using a conformity assessment certificate or an approval from eight recognised jurisdictions. The listing itself is free, normally vetted within 12 weeks, and valid for 5 years. But renewal has a strict window: 12 weeks to one year before expiry. Miss it, and you start again. Change is coming. The government plans a law requiring registration of all devices supplied in Hong Kong, unless exempted. On October 12, it named a Controller for Medical Products Regulation. Start with three things. One: appoint a Local Responsible Person in Hong Kong. Two: gather a recognised approval or a CAB certificate. Three: put the renewal window in your calendar. List now, prepare for registration. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.