Import & Export Medical Devices, Supplies from Taiwan FAQ

Business Community

The following are frequently asked questions by the business community about personal protective equipment (PPE) for the coronavirus disease 2019 (COVID-19).

Vaccine

What is the COVID-19 vaccine development status in Taiwan?

There are two Taiwanese companies developing COVID-19 vaccine – one is Medigen, and the other is United Biomedical, Inc.
On July 19, 2021, Taiwan FDA has given Emergency Use Authorization (EUA) to a COVID-19 vaccine developed by Medigen. United Biomedical, Inc. is preparing more data for EUA approval. Please feel free to contact these companies directly from “Biotech” section from below link, or contact TAITRA for arranging online meetings with them.
https://www.anticovid19tw.org/treatment/

Does Taiwan have a complete supply chain of COVID-19 vaccine or biosimilars?

Taiwan has strong biotech development and provides high quality CDMO (Contract Development and Manufacturing Organization) services to international companies, which helps to build up a supply chain of COVID-19 vaccine or biosimilars. There are a couple of companies who can provide DNA/RNA/Recombinant protein/ Adenovirus based CDMO services, such as EirGenix, Inc., Mycenax Biotech Inc., Medigen Vaccine Biologics., United BioPharma, Inc., Eden Biologics, Inc., Adimmune corporation and Formosa Laboratories, Inc.

Please contact TAITRA if you are interested in having more information or cooperation with these companies.

Testing Kits

The following are frequently asked questions about testing kits for the coronavirus disease 2019 (COVID-19).

Does Taiwan have COVID-19 Antigen Rapid Tests For Home Use?

Taiwan has a complete supply chain of biomedical industry. There are about 30 companies developing COVID-19 PCR, anti-body, and antigen test kits, which are mostly for professional use.

2 companies are capable of manufacturing certified home use antigen test kits – Panion & BF Biotech Inc. has acquired Taiwan and Thailand certification., while TaiDoc Technology has received certification from Taiwan, Thailand, Vietnam and Indonesia. Both companies already export and welcome international cooperation.

What is the supply status of testing kits?

It depends on orders and ranges from 1000 kits/month to 1000,000/month.

What is the status of Taiwan’s testing kit manufacturers applying for certifications approved by EU and FDA?

Please see the link.(連結到生態系圖試劑Detection)

What are the sensitivity and accuracy rates of testing kits or rapid tests.

Test kits or rapid tests in Taiwan have average accuracy rates of around 90-100 percent.
https://focustaiwan.tw/society/202005070013
https://en.rti.org.tw/news/view/id/2003110

Oxygen concentrator

Is there any customs and VAT on exporting ventilator to EU?

Commission waives customs duties and VAT on the import of medical equipment from non-EU countries (Expire on 31 December 2021).
Please refer to :
https://ec.europa.eu/taxation_customs/covid-19-taxud-response/covid-19-waiving-vat-and-customs-duties-vital-medical-equipment_en
Or you can contacct your nearest TAITRA branch for the future question: https://officeportal.taiwantrade.com/flash/big/unitList.jsp?lang=en_US

Does oxygen concentrator need medical certificate?

Oxygen concentrator is a classified medical device and have to be comply with local regulation before on sale. There are usually specific guidance and responsibilities that medical device manufacturer, importer and distributors have to follow.

Where can I buy oxygen generators/oxygen masks and other related products?

About PPE

Are face masks(medical devices) allowed to be exported from Taiwan?

Export restrictions on non-woven face masks, including medical, surgical and N95 respirators, were removed on June 1.

Once Taiwan begins exporting face masks again, what will Taiwan’s domestic face mask supply look like?

Daily production of face masks in Taiwan has increased from 1.9 million to 20 million. At least 60 percent of that will be exported.

What is the expected delivery time for face masks?

At this time most suppliers are at full production capacity. Normally the delivery time would be at least three months, depending on the quantity. Contact the supplier directly for more details.

What type of face masks can Taiwanese suppliers provide?

Taiwan supplies a wide range of face masks and respirators including medical (for both adults and children), surgical, FFP1-FFP3, N95 and PM2.5. We welcome you to visit the link to look into more information of suppliers.

How good is the quality of Taiwan-made face masks?

Taiwan has several suppliers like CSD, Motex, Taiwan Stanch and Aero Pro producing high-quality face mask products that meet ISO 9001 and ISO 13485 standards. Taiwan has been selling FDA- and CE-certified face masks around the world, including the US, Europe, Japan and Southeast Asia.

What is the manufacturing standard of face masks in Taiwan?

All face masks produced in Taiwan must meet TFDA standards (CNS 14774:2003). Below is the comparison between TFDA, FDA and CE.

Are melt-blown non-woven masks allowed for exporting?

There is no specific export restriction on melt-blown non-woven masks. However, in order to keep Taiwan’s domestic supply of face masks stable, all masks and materials for mask production are under government management.

What is the expected time for delivery of melt-blown non-woven masks?

It should be discussed with suppliers on the basis of quantity and other details. You can find contact information in the link.

Is mask production equipment allowed for exporting?

Mask production machines are allowed for exporting. Taiwan has supported many countries in building production lines by providing automated mask production machines. You can approach suppliers via this link.

What is the expected delivery time for mask production machines?

It would take approximately 45 to 180 days for the delivery of automated mask production systems due current production capacity being fully booked. It would be even longer for N95 respiratory manufacturing systems.

What are the advantages of Taiwan’s face masks?

Taiwan has become the second largest face mask supplier in the world. The Taiwanese government has established specific regulations and standards, similar to those of the United States, to ensure the quality of face masks. Most importantly, Taiwan is willing to join forces and partner with countries from around the world to assist in the fight against the COVID-19.

Are there any export restrictions for protective clothing products?

There are no export restrictions on protective clothing products. Before February 2020, more than 80 percent of protective clothing was imported in Taiwan. After the establishment of the national team, Taiwan now has sufficient domestic production capacity.

How long is the lead time for protective clothing products?

Generally, around 1 to 2 months, depending on the quantity and protection level.

How was Taiwan able to increase production on protective clothing products so quickly?

As a result of COVID-19, the Ministry of Economic Affairs of Taiwan (Bureau of Foreign Trade); Industrial Development Bureau; Taiwan External Trade Development Council; and  Ministry of Health and Welfare collaborated with textile suppliers to develop high-quality isolation gowns for medical use and ensure successful epidemic prevention.

Who is part of the Taiwan protective clothing national team?

The national team for protective clothing consists of six leading Taiwanese companies:

EclatPublic textile company

MakalotPublic textile company

Magictex/SingtexPublic textile company

New wide – 40-year-old textile company

TexRayPublic textile company

SheicoGlobal No.1 wetsuit manufacturer

For more details, please link to: (www.XXX防護衣連結)

What are the strengths of Taiwan’s protective clothing?

Taiwan has a stable and high-quality supply chain. All Taiwanese suppliers are market leaders and major suppliers to companies such as Schoffel, Tchibo, Puma, Adidas, Nike and VF group.

Share more about the quality of Taiwan protective clothing?

All raw material is produced in Taiwan, under sustainable process and RSL standards. All quality, lead time and customer service can be guaranteed by our supplier systems. All fabrics and gowns are certified and tested by the Taiwan Textile Research Institute. https://www.ttri.org.tw/en/index.aspx TTRI Lab certified by TAF (0491).

What level of protective clothing products do you have?

Please note that our national team members all have PPE Producer Certified Numbers, which is issued by Taiwan’s Ministry of Health and Welfare. We have P1~P3 level as follows:

Regarding testing of protective clothing, are there any comparisons?

Our multiple tests apply to Protective equipment. AAMI (Association for the Advancement of Medical Instrumentation) establishes a PB70 standard to provide manufacturers with a consistent basis for creating device labeling claims regarding barrier efficacy against liquid-borne microbes. Our P1 meets level 1; P2 meets level 3; P4 meets level 4 (for more details, please confirm with our national team member for specific needs).

Can you show some pictures that illustrate type/size.

For more details, please confirm with our national team member for specific needs.

Others

The following are frequently asked questions about manufacturing and suppliers in Taiwan that can help fight the coronavirus disease 2019 (COVID-19).

  

 

What would be the main focus of Taiwan's medical device industry in the post-pandemic era?

In an era where COVID-19 and the contactless economy are the new normal, Taiwan has taken the initiative and has prioritized the development of three key areas (preventive medicine, telehealth, and smart healthcare) to meet the demand of the emerging healthcare ecosystem market.

Digital technologies have been widely used in automated detection, genetic testing, and portable and wearable devices in the clinical fields.

How did Taiwan boost domestic manufacturing in such a short period of time?

After the first confirmed case on January 21, the Taiwanese government immediately executed an export restriction on face masks and controlled its distribution within that week. In the meantime, over 80 companies worked together through government coordination to build 92 mask production lines and began operating in two months.

Is there any support from TAITRA in setting up meetings with suppliers?

TAITRA can provide you with a list of potential suppliers for you to look into. You can then set up meetings with suppliers that meet your requirements. Afterwards, we can arrange company visits for you to facilitate your cooperation with a Taiwanese partner. You can contact TAITRA by sending an email to: mdd@taitra.org.tw.

Is there any way we can learn more about the development of Taiwan’'s industry? other than directly contacting TAITRA headquarters?

TAITRA has over 60 offices overseas. They will provide prompt service regarding local inquiries. You can find an office in or near your country at: https://officeportal.taiwantrade.com/flash/big/unitList.jsp?lang=en_US

How can I learn more about Taiwan’s featured anti-epidemic products?

Beside the products listed on the website, TAITRA has held several anti-epidemic livestream product launches and will continue to do so. You may contact your local TAITRA office for further information: https://officeportal.taiwantrade.com/flash/big/unitList.jsp?lang=en_US .

I’m interested in cooperating with a supplier in Taiwan. What can I do to approach them?

We’ve set up this website to help international partners more efficiently find suitable suppliers in Taiwan and help them make direct contact. You can find contact information from suppliers on the website. (連結生態系地圖)

How is Taiwan facing the supply bottleneck ?

It was the result of hard work, professional industrial skill and solidarity. The remaining mask production equipment manufacturers in Taiwan are very small with limited staff. It will take them four to six months to build 60 lines. Overall, it’s extremely challenging for manufacturers of mask production equipment to meet government objectives. Taiwan’s machinery manufacturers have plenty of experience supporting their international customers with flexible and customized smart manufacturing solutions. This experience is one of the reasons Taiwan was able to roll out mask lines so quickly when it was required. https://twmt.taiwantrade.com/news/a-bravery-story-a-taiwan-national-machine-tool-team-for-surgical-mask-production-born-to-fight-against-covid-19-outbreak-1979557.html

Except directly contacting TAITRA headquarters, is there any way we can know more about the development of Taiwan’s industry?

TAITRA has over 60 offices overseas and they will provide prompt service regarding inquiries in local. You can find the office in or near your country through https://officeportal.taiwantrade.com/flash/big/unitList.jsp?lang=en_US

Where do I find contact information for Taiwanese mask machine suppliers?

You may refer to:

  1. The protection section of Taiwan’s anti-epidemic solutions ecosystem on the website.
  2. Taiwan Nonwoven Fabrics Industry Association. (http://www.nonwoven.org.tw/)
  3. Contct TAITRA for more suppliers’ information.
How can I find medical mask producers in Taiwan?

Please refer to:
1. The protection section of the Taiwan anti-epidemic solutions ecosystem on the website.
2. Taiwantrade’s Anti-epidemic Area (https://anti-epidemic.taiwantrade.com) for quality products from Taiwanese suppliers.
3. Contact TAITRA for more information about producers.

Where can I find contact details to order mask materials?

You may refer to :
1. The protection section of Taiwan anti-epidemic solutions ecosystem on the website.
2. Taiwan Nonwoven Fabrics Industry Association (http://www.nonwoven.org.tw/)
3. Contct TAITRA for more suppliers’ information

Where can I find companies in Taiwan that provide remote healthcare solutions?

Please refer to:
1. The smart hospital section of Taiwan’s anti-epidemic solutions ecosystem on the website.
2. Taiwantrade’s Anti-epidemic Area (https://anti-epidemic.taiwantrade.com) for quality products from Taiwanese suppliers.
3. Contact TAITRA for more information about suppliers.

Are there manufacturers in Taiwan that produce medical gloves?

Please refer to:
1. The protection section of Taiwan’s anti-epidemic solutions ecosystem on the website.
2. Taiwantrade’s Anti-epidemic Area (https://anti-epidemic.taiwantrade.com) for quality products from Taiwanese suppliers.
3. Contact TAITRA for more information about suppliers.

How do I find companies in Taiwan that provide infrared temperature detection solutions?

Please refer to:
1. The protection section of Taiwan’s anti-epidemic solutions ecosystem on the website.
2. Taiwantrade’s Anti-epidemic Area ( https://anti-epidemic.taiwantrade.com) for quality products from Taiwanese suppliers.
3. Contact TAITRA for more information about suppliers.

I'm looking for potential business partnerships. Could you recommend any pharmaceutical and biotechnology industry organizations in Taiwan?

Please contact:
1. The Institute for Biotechnology and Medicine Industry (IBMI) (https://www.taiwan-healthcare.org/about)
2. Taiwan Bio Industry Organization ( https://taiwanbio.org.tw/en/)
3. Taiwan Research-based Biopharmaceutical Manufacturers Association (TRPMA)
(https://trpma.org.tw/eng)

I'm looking for potential business partnerships. Could you recommend any medical device industry organizations in Taiwan?

Please contact:
1.Taiwan Medical and Biotech Industry Association (TMBIA)
( https://www.tmbia.org.tw/)
2.The Institute for Biotechnology and Medicine Industry (IBMI)
(https://www.taiwan-healthcare.org/about)

What medical devices could potentially be exported to my country?

Taiwanese suppliers can export medical devices around the world. This includes  a full range of anti-epidemic products from machinery to materials and personal protection equipment (PPE) to smart medical solutions. You may refer to Taiwan’s anti-epidemic solutions ecosystem on the website or Taiwantrade’s Anti-epidemic Area (https://anti-epidemic.taiwantrade.com) for quality products from Taiwanese suppliers.

Where can I find information about entry restrictions for business travelers to Taiwan?

The most recently updated regulations are provided by the Bureau of Consular Affairs, Ministry of Foreign Affairs (https://www.boca.gov.tw/mp-2.html).

Where do I find information about suitable training programs, medical fellowships and research collaboration opportunities?

Please refer to Medic-All (https://www.taiwan-healthcare.org/medic-all) for information about hospital collaboration projects.

Taiwan has established a successful model in controlling the epidemic with smart technologies,artificial intelligence (AI) and big data. Where can I find further information and details about companies that provide such solutions?

You can access more information about how Taiwan used AI and Big data to contain the pandemic in the Taiwan Model section of the following website. To find information about Taiwanese companies for business discussions, please contact TAITRA.

Where do I find information about online events to better understand Taiwan’s medical industry?

TAITRA hosts many online trade promotion events. You are welcome to check the entire list of events at https://about.taitra.org.tw/OnlineEvents. You can participate in these events from the comfort of your own office.

How does the Taiwanese government control the quality of their medical devices? What standards are used?

The Taiwan Food and Drug Administration (TFDA) is the controlling authority in Taiwan for medical device products. The TFDA issues registration certificates and the Ministry of Health and Welfare (MOHW) performs on-site inspections of medical device manufacturers. For more information about manufacturing regulations, importation and sale of medical devices in Taiwan, please visit the TFDA website: https://www.fda.gov.tw/.

I would like to import medical devices from Taiwan and export medical devices to Taiwan. Where can I find the import and export regulations for Taiwan's medical devices?

For more information on regulations regarding the import and export of medical devices in Taiwan, visit the website for the Taiwan Food and Drug Administration: https://www.fda.gov.tw/ENG/.

When will Taiwan lift the ban on mask exports?

Taiwan lifted the ban on exporting masks on June 1, 2020, according to the Ministry of Economic Affairs.

How can a foreign company invest in Taiwan’s medical sector?

Biomedicine is one of the key industries of investment promotion for the Taiwanese government. You may refer to the Invest Taiwan website (www.investtaiwan.nat.gov.tw) for information about incentive programs for foreign investors or contact TAITRA for more information.

What organizations can provide consultation services for establishing cooperative joint ventures with companies in Taiwan’s medical device sector?

The Taiwan External Trade Development Council (TAITRA) provides up-to-date information about Taiwan’s trade and investment opportunities to help foreign companies who are interested in the Taiwanese medical devices market. Please refer to their website for further information: www.taitra.org.tw.

How can I obtain trade statistics?

The trade statistics of Taiwan is issued by the Customs Administration, Ministry of Finance. You can access from the website :https://portal.sw.nat.gov.tw/APGA/GA30E

Are there any sourcing e-commerce platforms for anti-epidemic products?

You may access Taiwantrade’s Anti-epidemic Area ( https://anti-epidemic.taiwantrade.com) for information about quality products from Taiwanese suppliers.

I would like to visit a trade show in Taiwan. Can I apply for a Buyer Incentive Program?

Yes, you can contact the TAITRA Overseas Office in your region (https://officeportal.taiwantrade.com/flash/big/unitList.jsp?lang=en_US).

Are there any medical-related virtual exhibitions in Taiwan?

Yes. You are welcome to check out these virtual exhibitions:
1. Taiwan Excellence Healthcare Virtual Pavilion (https://www.taiwanexcellence.org/en/healthcare)
2. Bio Asia-Taiwan (https://bioasiataiwan.com/)
3. Medical Taiwan 2D Exhibition (https://www.medicaltaiwan.com.tw/) (the show will be launched on October 15, 2020)

Which trade shows in Taiwan are showcasing epidemic prevention products?

You are welcome to visit:
1.Medical Taiwan (October 15-17, 2020)
2.Bio Asia (July 22-26, 2020)
3.Taiwan Healthcare+ (Dec 3-6, 2020)

COVID-19 has boosted the contactless economy. What kind of contactless products can we source from Taiwan?

Taiwanese suppliers can provide contactless solutions ranging from telework, distance learning and gaming. You can find more information about contactless products in the contactless section of the Taiwan anti-epidemic solutions ecosystem on the website.

Where can I find information about products and offerings from Taiwan?

You can find up-to-date information and catalogs on 660,000+ products by Taiwanese companies on Taiwantrade.com, the top B2B portal of Taiwan.

Where can I connect with Taiwanese suppliers?

You can connect with 70,000+ Taiwanese suppliers via the various customized sourcing services available free for buyer members on Taiwantrade.com.

How can I become a buyer member on Taiwantrade.com?

Sign up for your buyer account free via the following link: https://www.taiwantrade.com/register/buyer?language=en

I need assistance on finding a specific product/supplier…

Get the most out of your sourcing experience on Taiwantrade.com and use our customized services, available free for buyers:

Use “Trade inquiry” and let our team help you find a product/supplier that meets your needs => https://www.taiwantrade.com/business/TradeInquiry

Use “Meet Suppliers Online” for our team to help you arrange a video meeting with potential suppliers for your business => https://www.taiwantrade.com/business/MeetSupplierOnline

A trade show was postponed. Where can I find up-to-date info about products in my industry?

Check out the industry categories on Taiwantrade.com. For a specific product in your industry, try browsing through the sub-categories under each industry field.

I’d like to source anti-epidemic products from Taiwan…

You can find over 10,000 quality anti-epidemic products on the Taiwantrade.com Anti-Epidemic Online Showcase (https://anti-epidemic.taiwantrade.com/). You can make small quantity orders and message suppliers directly via the website.

I’d like to see a full showcase of anti-epidemic products…

The Taiwantrade.com Anti-Epidemic Online Showcase (https://anti-epidemic.taiwantrade.com/) exhibits over 10,000 quality anti-epidemic products, including face masks, thermometers, isolation gowns, medical gloves, mask making machines and sanitation supplies. You can message suppliers directly via the website.

Can you recommend me suppliers based on my requirements?

Yes. Place a request on https://www.taiwantrade.com/business/TradeInquiry, and our team will email you a list of potential suppliers based on your needs.

I’d like to have a video call with a supplier…

We can help arrange online meetings for you with a list of potential suppliers. Apply for a session here: https://www.taiwantrade.com/business/MeetSupplierOnline.

About the Taiwan Anti-Epidemic Solutions Ecosystem

Taiwan can provide a wide variety of anti-epidemic solutions, including: equipment and machinery, medical materials, protective gear, medical devices, and COVID-19 testing kits, as well as all types of smart health solutions and medical services. See a full list of suppliers on the Taiwantrade.com Anti-Epidemic Online Showcase: https://anti-epidemic.taiwantrade.com/.

About TAITRA

TAITRA is Taiwan's foremost nonprofit trade promoting organization. Sponsored by the government and industry organizations, TAITRA assists enterprises to expand their global reach. Headquartered in Taipei, TAITRA operates 5 local offices as well as 63 branches worldwide.

⦿ UPDATE:Participants in Medigen Phase 3 clinical trials receive first shot ⦿ UPDATE:Long COVID treatment now available at Taipei hospitals ⦿ UPDATE:Medigen accepted for travel in four countries: CECC