Hong Kong’s Medical Device Division has updated its document checklist for medical device listing applications under the Medical Device Administrative Control System (MDACS). The MDACS framework requires all medical devices supplied in Hong Kong to demonstrate compliance with internationally adopted safety, quality, and performance standards.
Device manufacturers must submit a valid Quality Management System certificate. Accepted forms include ISO 13485, China’s GB/T 42061, an NMPA Manufacturing License, an MDSAP certificate, or Korean GMP certification. In addition, device manufacturers must also provide marketing approval from one of eight recognized jurisdictions: Mainland China, Australia, Canada, the EU, Japan, Singapore, South Korea, or the USA, or alternatively, an MDACS Conformity Assessment Certificate.
The Local Responsible Person (LRP), the manufacturer’s representative in Hong Kong, will need to provide its own set of documents, including a Hong Kong Business Registration Certificate, a manufacturer’s letter of designation, documented operating procedures, and any relevant local licenses such as a Wholesale Dealer License.
Device-specific documentation requirements include labelling samples, a risk analysis report, a clinical or performance evaluation report, a recall and adverse event history, and an Essential Principles Conformity Checklist. The Medical Device Division may request additional information at any time, and failure to respond can result in closure of the application. As previously reported, Hong Kong authorities are taking a more active role in device approvals, moving beyond reliance on foreign regulatory clearances.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.