Updated: 7/28/00. Taiwan announced a new medical device reclassification on June 30, 2000. See report for more information.

Updated: 6/27/01. The U.S. Medical Device Industry held consulations in Taiwan in April 2001 to discuss various medical device regulatory and reimbursement issues. Read the report.

Regulatory Agency

All medical devices are regulated by the Bureau of Pharmaceutical Affairs (BPA), the Department of Health (DOH).

Regulatory Framework

Medical devices are regulated under the Pharmaceutical Affairs Law. Devices can be broken down into two categories: those that require pre-market approval and those that do not. The route for any product not listed on either list would be for the importer to apply to the BPA for a case-by-case decision. If everything is in order, a license is usually granted within six months.

Standards Compliance

Taiwan is currently in the process of harmonizing domestic medical device classification with commonly used international classification system. In addition, all medical devices will now need to meet the Good Manufacturing Practice (GMP) requirement. The GMP is based on the ISO 13485.

GMP Requirements

Good Manufacturing Practice (GMP) requirements were introduced in February 1999. Newly established factories and all new applications for pre-market approval have to comply with GMP. There is a five year grace period for those devices already registered and on the market. Full compliance, however, becomes mandatory for these products after February 10, 2004.

The Department of Health both performs on-site inspection for local manufacturers and reviews quality system documentation provided by foreign manufacturers. Quality System Documentation (QSD) are based on the 20 requirements of the GMP (ISO13485).

The DOH and USFDA signed an Exchange of Letters on January 9, 1998. According to this Exchange of Letters, FDA agrees to provide purged copies of medical device Establishment Inspection Reports (EIR's) of the United States manufacturers that export to Taiwan upon request. As a result, medical devices manufactured in the U.S. are exempted from being required to submit quality system documentation if all the following documents are included in a submission to DOH: (1) FDA's Establishment Inspection Report (EIR's) (2) Certificate to Foreign Government; (3) ISO 13485 certificate.

Medical Device Classifications

The DOH, following the USFDA's 21 Code of Federal Regulations (CFR), has classified medical devices into three classes, as follows:

Class I:

The device is not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present the potential for unreasonable risk of illness or injury.

Class II:

The device is purported or represented to be for use in supporting or sustaining human life.

Class III:

The device is life-supporting or sustaining or for a use which is of substantial importance in preventing impairment of human health. Or, the device may present the potential for unreasonable risk of illness or injury.

The DOH reclassified the medical devices into 16 categories, as follows:

A. Clinical chemistry and clinical toxicology devices
B. Hematology and pathology devices
C. Immunology and microbiology devices
D. Anesthesiology devices
E. Cardiovascular devices
F. Dental devices
G. Ear, Nose, and Throat devices
H. Gastroenterology-Urology devices
I. General and Plastic Surgery devices
J. General hospital and personal use devices
K. Neurological devices
L. Obstetrical and Gynecological devices
M. Ophthamlic devices
N. Orthopedic devices
O. Physical medicine devices
P. Radiology devices

For detailed information on the reclassified categories of medical devices, please visit the website http://www.doh.gov.tw/new/announce/ 89/890703-1.htm for reference. Please see "attachment 1" for a list of products by category, "attachment 2" for Class I products exempt from GMP, and "attachment 4" for Class II products exempt from product registration.

Devices Requiring Pre-Market Approval

A medical device manufacturer who wishes to export medical devices to Taiwan must assign a local agent/distributor in Taiwan who can apply on the manufacturer's behalf for a product license. The following documents are required along with the application to the BPA:

A letter of authorization which:

· states the name of the device, model(type), name and address of manufacturer and of agent

· states that the agent is authorized to register the product

· shall be original

· shall be valid for one year from the issued date

A certificate of free sale which:

· states the name of the product, model(type) and name and address of the manufacturer

· states that the device(s) is/are freely sold in its home market

· shall be legalized by the Taipei Economic and Cultural Office (TECRO) representative in your area

· shall be original

· shall be valid for two years from the issued date

A leaflet (7 copies) which shall state the name, structure, specification usage, administration and manufacturer's name and address of the device (8 copies are required for radioactive equipment)

Quality control record (including testing methods and results) (2 copies). This is required for all medical devices.

Form, structure, dimension, raw material of ingredient, and quantity, performance, purpose of use, indication or effect

A sample of the device (if feasible)

Clinical reports (2 copies) for newly developed devices or for approved medical devices with a new intended purpose or some special devices such as implantable appliance, contact lenses etc.

Circuits and testing records of electrical installation (only for electrical equipment) (2 copies)

Instructions for operating security (only for electrical equipment) (2 copies)

Operating records of automatic measurement adjustment (only for automatic temperature adjusting equipment) (2 copies)

Testing records and certificate of radiation leakage (only for radioactive equipment) (2 copies)

Labels and Instruction for Use

Labels, instructions and dossiers must be provided in Chinese. English is not widely understood.

Clinical Investigations

Hospitals in which clinical investigations will be conducted with unapproved medical devices should submit a clinical trial proposal to the DOH. After approval by the DOH, hospitals will be able to import the device directly or entrust a local agent to carry out the import procedures.

In Vitro Diagnostics (Test Kits)

There are no known non-tariff barriers imposed on the importation of diagnostic test kits and diagnostic instruments in Taiwan, nor are there any impediments that threaten market access. Currently, there are no forthcoming regulations and no legislation that might prove to be an impediment to imports. To encourage the development of biotechnology, no tariff is imposed on the importation of hematology analyzers, blood cell counters

and multifunction clinical automatic analyzers. Tariff rates range from five percent to ten percent for composite diagnostic or laboratory reagents in Taiwan.

Pre-marketing registration for imported diagnostic test kits (hepatitis diagnostic reagents, human immnodeficiency virus antibody diagnostic reagents, ABO blood-grouping reagents and lymphocytic virus diagnostic reagents) is required in Taiwan.

An American supplier must first appoint a Taiwan agent or its Taiwan Branch to file an application for registration with Taiwan's Department of Health (DOH) in order to obtain an import license. The goods may be imported after the import license is obtained. The following materials are required for registration in Taiwan:

1. An authorization letter (power of attorney)

2. A free sale and origin certificate issued by the highest

health authorities

3. Company profile & plant master file, brief history, premises,

organization, detail of manufacturing and Q.C. equipment,

facilities and their capacities, capital amount, number of

employees, item of product, and G.M.P. master file

4. List of component composition

5. Three sets of samples (each set is enough to perform one assay

for this product)

6. Five sets of labels, cartons, and package inserts

7. Specifications, control procedures and analysis results of

each raw material contained in the product

8. Summary of procedure for production and in process control

9. Specifications, analysis methods and results of each active

ingredient in finished products

10. Stability test program and report for final diagnostic kit

11. For evaluation of the safety & efficacy of the product, the

clinical materials are required as much as possible.

12. Local clinical trial report (for Hepatitis products only)

13. In-house panels preparation procedures

14. Production and characterization of antigen and antibody

15. Quality control procedures and specification for final

diagnostic kit and all components

16. Certificate of analysis for final diagnostic kit

17. Performance evaluation report for final diagnostic kit

The letter of authorization, the free sale and origin

certificate, and company profile & plant master file must be

notarized by The Taipei Economic & Cultural Representative Office

(TECRO) in the United States. An American firm may contact the

DOH for further information on regulatory and registration

issues:

Department of Health, Executive Yuan
100 Aikuo E. Road, Taipei, Taiwan
Tel: 886-2-2396-7166
Fax: 886-2-23418994
Contact: Mr. Chi-Shean Chan, Director-General

Contacts:

Department of Health
Bureau of Pharmaceutical Affairs
The Executive Yuan
11th Floor, No. 100, Ai Kuo E. Road
Taipei, Taiwan

The American Institute in Taiwan is a private non-profit corporation established to carry out relations between the people of the United States, and the people of Taiwan. AIT's Commercial Section includes the mission of helping U.S. firms export their goods and services to Taiwan.

You can contact the following for more information.

Gregory Harris, Commercial Officer
Angeli Chou, Specialist
Commercial Section
American Institute in Taiwan
Rm. 3207, 333 Keelung Road, Sec. 1, Taipei, Taiwan
Tel: 886-2-2720-1550
Fax: 886-2-2757-7162
E-mail: Gregory.Harris@mail.doc.gov or Angeli.Chou@mail.doc.gov

Appendix 1: For more information, read the following 2005 Commercial Service Reports.

AACC 2005 Market Brief for Taiwan

Taiwan's Implantable Medical Device Market

Medical Device Registration in Taiwan