TAIWAN MEDICAL DEVICES MARKET

INTRODUCTION

The Taiwan Food and Drug Administration (TFDA), a branch of the Ministry of Health and Welfare, is in charge of monitoring medical devices. Starting in May, the new Medical Devices Act will control the regulatory framework.

Classifying the product into one of the four categories listed below is the first step in selecting the regulatory pathway:I class (Low Risk),Type II (Medium Risk),Type III (High Risk).New (No predicate device previously approved by TFDA) (No predicate device previously approved by TFDA).

Applications for Class II, Class III, and New Medical Devices will be reviewed in two stages: administrative and technical. Products in Class I simply need to undergo an Administrative Review.

Only Class III IVDs and new products need clinical data. Class II medical devices with US or EU approval can typically substitute preclinical testing, quality control procedures, and test results with existing documentation.

The License is good for five years after it is issued. In Taiwan, licences can be transferred, although doing so requires cooperation from both the transferor and the transferee.

TAIWAN MEDICAL DEVICES MARKET SIZE AND FORECAST

Taiwan medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.

TAIWAN MEDICAL DEVICES MARKET DYNAMICS

The Taiwanese government intends to introduce new standards for distribution, unique device identification (UDI), and other processes with the publication of new medical device legislation.

Through a phased implementation plan, Taiwan's Medical Devices Act (link in Chinese) creates a new regulatory framework for medical devices. Several essential components of the new rule that the Taiwan Food and Drug Administration will implement (TFDA).

The Premarket E-Submission Portal was set up by the Taiwan Food and Drug Administration with the goal of making it simpler for manufacturers to submit their applications.

The new system, which is applicable to Class II and III items and will enable paperless submission, was introduced in March. This was done in an effort to hasten the application process after the new regulations took effect in 2021. Although not required, manufacturers are encouraged to use the system.

Only Class III IVDs and new products need clinical data. Preclinical tests, quality control procedures, and test reports are typically not required for Class II medical devices that have received approval in the US or EU. Instead, existing documentation can be used.

TAIWAN MEDICAL DEVICES MARKET COMPANY PROFILES

• Suntec Medical
• Pharmadax
• Vectorite Biomedical
• Senhwa Biosciences
• Veristat

THIS TAIWAN MEDICAL DEVICES MARKET REPORT WILL ANSWER FOLLOWING QUESTIONS

1. How many medical devices are manufactured per annum in Taiwan? Who are the sub-component suppliers in this region?
2. Cost breakup of a Taiwan medical devices and key vendor selection criteria
3. Where is the medical devices manufactured? What is the average margin per unit?
4. Market share of Taiwan medical devices market manufacturers and their upcoming products
5. Cost advantage for OEMs who manufacture Taiwan medical devices in-house
6. key predictions for next 5 years in Taiwan medical devices market
7. Average B-2-B medical devices market price in all segments
8. Latest trends in medical devices market, by every market segment
9. The market size (both volume and value) of the medical devices market in 2024-2030 and every year in between?
10. Production breakup of medical devices market, by suppliers and their OEM relationship