The Third House Emma Tong, Medical Device RA
Every step to market,
grounded in evidence.
See the problem clearly before deciding what comes next. Regulatory work is not the final gate.
Product definition, use context, risk, technical data and market strategy shape one another early. The sooner a clear structure is in place, the more a team can spend on the evidence and decisions that matter. Markets and products differ, so the work begins with what is already known, never with one answer applied to every project.
Clear Boundaries
Advisory work does not guarantee approval. Market authorisation rests with the authority, on formal evidence and procedure. Our value lies in making product information, documents and workflow clearer and traceable.
I. Four Questions Before the Regulations
Every product needs
its own chain of evidence.
What is the product?
Are its characteristics, intended use, users and environment clear?
Where will it go?
Are the target market, business model and product role confirmed?
What evidence exists?
Where are the technical, performance, risk, clinical or usability data today?
What remains to be confirmed?
What must be judged further by the authority, a test laboratory, the quality system or a regulatory professional?
II. Modules and Fees
Complex regulatory work,
broken into steps you can begin.
The starting point is not a package but your product as it stands and the market you intend to enter.
Module 01 Initial Regulatory Review
Describe the product as it stands, then decide what comes next.
| Service | Scope | Billing | Fee |
|---|---|---|---|
| Thirty-minute initial review | Product type, intended use, stage, target markets and existing documents; afterwards a note of what is known, what remains open, and the next practical step | per review, fully credited on engagement | NT$3,000 |
Module 02 Regulatory Strategy and Positioning
Define the product's boundary, intended use, risk and priority markets before choosing a path.
| Service | Scope | Billing | Fee |
|---|---|---|---|
| Product and regulatory scope review | Scope, initial comparison with one market's authority, gaps and priorities | per product | NT$60,000 |
| Additional market comparison | Classification and pathway for each further market: TFDA, FDA or EU MDR | per market | NT$28,000 |
| EU MDR gap assessment | Gaps between existing documents and MDR requirements, with an order of remedy | per device family | NT$120,000 |
Module 03 Technical Documentation and Submission
Existing evidence, technical data and document structure, organised to support your submission.
| Service | Scope | Billing | Fee |
|---|---|---|---|
| TFDA Class I listing support | Document preparation and electronic filing support | per device | NT$25,000 |
| TFDA Class II registration support | Technical File or STED structure, submission checklist and tracker, testing coordination | per device, from | NT$150,000 |
| TFDA Class III registration support | As above, with clinical and risk management documentation | per device, from | NT$320,000 |
| US FDA 510(k) documentation | Substantial equivalence structure, submission package, FDA interaction planning | per submission, from | NT$560,000 |
| EU MDR technical documentation | Structure and compilation support for Class I and IIa | per device family, from | NT$420,000 |
Module 04 Overseas Brand Agency and Introduction
Helping overseas brands understand regulation, agency qualification and local readiness before entry.
| Service | Scope | Billing | Fee |
|---|---|---|---|
| Pre-entry feasibility review | Classification, agency qualification, required documents and timeline | per brand | NT$68,000 |
| Agency and product documents | Agency papers, product data and Chinese labelling advice | per project, from | NT$38,000 |
| Clinic and hospital readiness | Product briefing and communication preparation for institutions | per project | NT$32,000 |
Module 05 Post-Market Change and Licence Maintenance
When product, documents or supply chain change, a steady rhythm for assessment and updates.
| Service | Scope | Billing | Fee |
|---|---|---|---|
| Change registration support | Initial review of the change and document updates | per change | NT$28,000 |
| Annual licence maintenance | Maintenance checklist, internal handover and tracking | per month, annual term | NT$15,000 |
Module 06 Hourly Counsel and Compliance Review
Small questions also deserve careful answers.
| Service | Scope | Billing | Fee |
|---|---|---|---|
| Regulatory consultation | Written | per hour | NT$5,000 |
| Compliance review of device marketing | Claims and wording in one article, brochure or web page | per item | NT$6,800 |
| Medical device content assets | Regulatory review by Emma Tong, knowledge graph and content structure by GuanCheng Martech | per project | NT$86,000 |
All amounts are in New Taiwan Dollars and exclude 5% business tax. Media budgets, government fees, testing, notified-body fees and other third-party costs are separate. Where a price reads “from”, the final figure is fixed in the written proposal according to the number of brands, markets, pages or contacts, and does not change thereafter. TFDA registration fees, US FDA user fees, EU notified-body fees, testing and clinical costs are paid separately by the client.
III. Two Disciplines, One Path to Market
Enter lawfully first,
then be understood clearly.
Emma Tong Leads
- Regulatory strategy and documentation
- Overseas agency qualification and introduction
- Clinic and hospital relationships
- Post-market change and licence upkeep
Shuoguo Zhixin Leads
- Digital strategy and content, by GuanCheng Martech
- Online visibility and lead development
- Marketing copy and proposals from product data
- Market feedback gathered for the team’s next decisions
On collaboration. Emma Tong and Shuoguo Zhixin Advisory provide independent professional services under separate contracts, scopes, data permissions and responsibilities. Marketing content never replaces product labelling, approved indications or regulatory requirements.
IV. Official Resources
Before you search,
ask whether it is evidence.
- Taiwan TFDA device registrationOfficial portal for registration, licences, changes, renewals and e-filing
- US FDA premarket submissionsGuidance on 510(k), PMA, De Novo, HDE and IDE
- EU MDR and IVDREuropean Commission updates, guidance and implementation resources
- Taiwan device registration fee scheduleGovernment fees are charged separately under this schedule
Service statement. This page offers general information on device regulation and an introduction to advisory services. It is not legal, medical or clinical advice. TFDA, FDA and EU MDR requirements, guidance and timelines may change; classification, document lists, strategy and eligibility must follow the latest official notices and a formal case assessment.
Please do not enter confidential technical data, patient data or unpublished designs in the initial form. Before any technical review, both parties complete a confidentiality arrangement.
Part of Shuoguo Zhixin Advisory