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The cost and time required for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) depend on several factors, including the completeness of the application, the complexity of the device, and the current workload of the Medical Device Division (MDD).
💰 Cost of Registration
As of now, MDACS does not charge an application fee for the listing of Class IV medical devices. However, applicants should be aware of potential costs associated with the registration process:
Local Responsible Person (LRP) Fees: If the manufacturer is based outside Hong Kong, appointing an LRP is mandatory. The fees for LRP services can vary, typically ranging from HKD 10,000 to HKD 50,000 or more annually, depending on the service provider and scope of responsibilities.国瑞中安集团
Documentation Preparation: Costs may be incurred for preparing necessary documentation, including technical files, clinical evaluation reports, and translations if documents are not in English or Chinese.国瑞中安集团
Quality Management System (QMS) Certification: Obtaining or updating certifications like ISO 13485 for the manufacturing facility may involve additional expenses.国瑞中安集团
⏱️ Time Required for Registration
The registration timeline for Class IV medical devices under MDACS can vary based on several factors:
Initial Acknowledgment: Upon receiving an application, the MDD typically acknowledges receipt within 2 weeks, assigning an application number. 医疗器械处
Review and Approval: The MDD aims to complete the vetting and approval process within 12 weeks following the submission of a complete application and all required supporting information. 医疗器械处
However, the actual processing time can extend beyond this period due to factors such as:
Completeness of Application: Incomplete or unclear submissions may lead to requests for additional information, causing delays.国瑞中安集团
Device Complexity: High-risk or novel devices may require more extensive evaluation.
MDD Workload: Periods of increased submissions can affect review timelines.国瑞中安集团+2国瑞中安集团+2国瑞中安集团+2
In practice, the total time from submission to approval can range from 6 to 12 months or more. 国瑞中安集团
📌 Summary
| Item | Details |
|---|---|
| Application Fee | None (currently) |
| LRP Service Fees | Approximately HKD 10,000–50,000+ annually |
| Other Costs | Documentation preparation, translations, QMS certification |
| Initial Acknowledgment | Within 2 weeks of application submission |
| Review & Approval Time | Typically 12 weeks; may extend to 6–12 months or more depending on factors |
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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