Taiwan’s Food and Drug Administration (TFDA)
Medical Devices
In Taiwan Medical Devices are regulated by the Taiwan Food and Drug Administration (TFDA), Taiwan’s equivalent of the United States FDA. The TFDA rests under the authority of The Ministry of Health and Welfare (MOHW) who performs on-site inspection for local manufacturers and reviews Quality System Documentation (QSD) provided by foreign manufacturers.
Medical Device Regulations:
Taiwan’s Pharmaceutical Affairs Act regulates the administration of pharmaceutical affairs, which includes drugs and medical devices, pharmaceutical firms, pharmacies, and other relevant matters. Various regulations were established pursuant to the Pharmaceutical Affairs Act to expand on the details not specifically covered in the Act.
Market Authorization :
All imported medical devices must obtain a registration certificate from the TFDA. The regulatory process for new medical devices in Taiwan is often complicated and unclear. Most of Taiwanese regulations are in the Mandarin Chinese language and are constantly being changed by the TFDA health authorities.
GRP Medical Device Services :
Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts and affiliated partners in Taiwan who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Taiwan’s market.
More Resources:
- TFDA check website
- More information is available under “Read More” Tab
Authorized local agent
Medical companies without presence in Taiwan, should have a local agent that can register their products, maintain their product registrations, get the QDS approved, report all adverse events, and coordinate recalls on their behalf. Global Regulatory Partners, Inc. (GRP) can act as your local agent and provides the following medical device services:
GRP Medical Device Services in Taiwan:
- Communication with the TFDA
- Assistance with TFDA inspections
- Adverse Effect Reporting
- Importation of products
- Organize and support TFDA consultation meetings
- Product registration
- Clinical Trial management
- Support importation process
- Post-market vigilance
- Manage Distributors
Regulatory intelligence
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.
At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest TFDA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Taiwan.
Regulatory Strategy
The regulatory process from product’s design to market entry for new medical devices is often complicated and unclear. Most of Taiwanese regulations are in Taiwanese language and are changing constantly.
Developing the right regulatory strategy is crucial for successful medical device registration in Taiwan. GRP regulatory team stays current with the latest medical devices’ legislation, regulatory requirements and industry initiatives, and always makes sure to communicate these changes to its clients. While developing regulatory strategies, GRP regulatory team takes into consideration the changes in the regulatory landscape.
GRP Medical Device Regulatory Strategy Services in Taiwan:
- TFDA Regulatory Background
- Product Assessment based on TFDA Requirements
- Device Classification based on TFDA rules
- Authorized Representation requirements for Taiwan
- Medical Device Registration Requirements
- Labeling Requirements
- Costs and Timeframes
- Regulatory Roadmap for Taiwan
- Post-market Surveillance Requirements
Regulatory Affairs
Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Taiwan include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Taiwan in order to successfully register and commercialize their products in Taiwan’s market and maximize the value of their assets.
Product registration
| Device Class | Risk Level |
|---|---|
| Class I | Low risk |
| Class II | Moderate risk |
| Class III | High risk |
| New Medical Device (PMA) | If there are no similar devices previously approved by the TFDA, your device will be considered a PMA device. This is the case even if your product has a Substantially Equivalent (SE) device approved by the U.S. FDA. |
Pre-Market Approval Process in Taiwan
| Determine medical device classification | ||
|---|---|---|
| Class I | Class II | Class III |
| Appoint Taiwan Agent |
|---|
| Must have a legal entity established in Taiwan, certified with a Pharmaceutical Sales License) |
Prepare QSD application (manual an manufacturing application), ISO 13485 certificate, and QSD certtificate. Submit QSD application for approval. (Certain non-sterile Class I devices are exempt from QSD registration).
Submit QSD application for review by TFDA
| Obtain QSD approval letter |
|---|
| *When approved – QSD approval letter will be valid for 3 years |
| Class II and III |
|---|
| Obtain a Certificate of Free Sale (CFS) or Certificate of Foreign Government (CFG) |
| Class II and III |
|---|
| Prepare registration application and dossier to the TFDA. |
| Class I |
|---|
| Prepare registration application for submission to TFDA. Documents include: product information such as labeling and IFU and QSD Approval Letter (if required). |
Pay Application Fee
Receive TFDA approval
Appoint Licensed Distributor
Taiwan Agent Files and authorization application for importation of products
Distributor receives TFDA approval letter
Begin marketing of device in Taiwan
Medical writing
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Taiwan. As Regulatory authorities, the TFDA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Health authority consultation
It is highly recommended to have a pre-consultation meeting with health authorities such as with the Taiwan Food and Drug Administration (TFDA), during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the TFDA before starting key milestone of your product development.
GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the TFDA health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.
Clinical
Clinical data is required for all PMA devices and Class III IVD and DOH designated medical devices. Foreign clinical data from Western countries are generally acceptable.
| Device Class | Clinical Trial Requirement | Description |
|---|---|---|
| Class I | Not required | Class I medical devices no longer need to be registered with the TFDA; instead, a notification must be filed with the relevant local level Chinese TFDA. However, for the notification application, more documents will be required than there were for Class I registration. |
| Class II and Class III Devices | Required |
• Mandarin Chinese Specification Drafting (Dossier Preparation and Specification Drafting): 1 month • Sample Testing: 6 Months • Filing to the CFDA- Preliminary review and acceptance notice: 1 Month • CMDE Review- Supplementary notice: 60-90 Business days (2-3 months) • Supplementary Dossier preparation: 1 year • CMDE Review: 60 Business days (2 months) • TFDA Final review- Registration approval: 30 Business days (1 month) |
Exceptions For clinical trials:
- The product has a clear working mechanism, finalized design, and mature production technology. A medical device of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events. There will also not be any changes to the product’s conventional usage.
- The safety and efficacy of the product can be proven through non-clinical evaluations.
- The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.
GRP’s clinical trials services in Taiwan
Clinical Trials Management
We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
Adverse Events and Post Market Surveillance
We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.
Quality Compliance and Audits
We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
Clinical Trial Consulting Services
GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
Regulatory Support
We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Taiwan. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate TFDA regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
Quality
As part of medical device registration process in Taiwan, medical device companies must register their manufacturing facilities by submitting and getting approval for their Quality System Documentation (QSD). QSD registration is only waived for Class I (non-sterile) medical devices. A QSD license (received upon QSD registration approval) in Taiwan, is similar to Good Manufacturing Practice (GMP) for medical devices.
ISO 13485:2016
ISO 13485 quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements serves as the basis for QMS compliance worldwide.
Advantages of ISO 13485 certification
If you manufacture or market medical devices you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:
- It is the “de facto” standard for global medical device QMS compliance for medical devices and is a prerequisite for access to most major markets worldwide.
- ISO 13485 certification requires effort to attain and maintain, so it gives you additional credibility and legitimacy with potential customers.
- Increased efficiency, better product quality and improved customer service within your company.
- Your commitment to quality will be evident to your consumers and partners
GRP ISO 13485 Services:
- Customization of your ISO 13485 quality system to meet your specific needs,
- Training on ISO 13485 requirements
- Ensure that your QMS is implemented on time and on budget.
- Provide qualified recommendations for third-party testing and certification firms that specialize in your category of devices.
