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Here’s a clear summary of the costs and timeline involved in applying for Class D medical device MDACS registration in Hong Kong:
💰 Costs for Class D MDACS Registration
| Cost Item | Details | Estimated Amount |
|---|---|---|
| Government Application Fee | Currently, MDACS registration is voluntary and free of charge; no government fees apply as of now. | HKD 0 |
| Local Responsible Person (LRP) | If you hire a Hong Kong-based agent to act as your LRP, they usually charge a yearly service fee. | HKD 10,000 – 30,000 per year |
| Consultant/Regulatory Service Fee | Many companies engage consultants to prepare the technical file and handle submission. | HKD 30,000 – 100,000+ depending on complexity |
| Testing and Certification Costs | May include ISO 13485 QMS audit, clinical evaluation, safety and performance testing, and translation of documents. | Variable, typically HKD 50,000 – 200,000+ |
| Renewal Fee | Not currently applicable since listing is valid indefinitely or for 5 years under voluntary system; fees may be introduced after ordinance enforcement. | N/A |
⏳ Timeline for Class D MDACS Registration
| Stage | Estimated Duration |
|---|---|
| Preparation of dossier | 1–3 months (depends on document readiness) |
| Application submission | Instant via MDIS platform |
| Initial completeness check | 2–4 weeks |
| Technical review by MDD | Typically 3–6 months, can extend up to 12 months depending on complexity and queries |
| Response to MDD queries | Usually 2–4 weeks per round of clarification |
| Listing approval & issuance | Upon satisfactory review; typically within 6–12 months from submission |
⚠️ Important Notes
MDACS is currently a voluntary registration system; full mandatory registration will come after the Medical Device Ordinance (MDO) is enacted.
No official government fees are charged now, but this may change when the MDO comes into effect.
Longer timelines can occur if supplementary data or clinical evidence is required.
The costs vary greatly depending on whether you already have overseas approvals, how much documentation needs to be prepared, and if you use third-party consultants.
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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