Late last year, Hong Kong’s Medical Device Department made public Technical Reference TR – 007. The guidance defines and classifies Software in a Medical Device (SIMD) and Software as a Medical Device (SAMD). SIMD is used for medical purposes and controls or operates a medical device, whereas SAMD is a standalone product able to achieve its intended medical use without being tied to a hardware medical device. Both versions follow Hong Kong Medical Device and IVD Registration Requirements per technical references TR-003 and TR-006.
For product registration, the technical documentation required includes – a QMS system, the Medical Device Administration Control System Essential Principles Conformity Checklist, detailed labeling requirements, risk management, clinical evaluation, etc. In addition, software products also require software verification and validation and cybersecurity management. For cybersecurity, an applicant should take note of ISO 27032 and ISO/IEC 27001. Registration can be expedited if the device is approved in two countries, including the US, EU, Japan, Canada, Australia, and now China and Korea too.
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.
Source used in the article: https://www.mdd.gov.hk/en/home/index.html