In accordance with FDA YaoZi No. 1041400206 announcement, Application Processing Timetable of Food and Drug Administration, Ministry of Health and Welfare, issued on June 29, 2015

According to the Announcement ShuShouShiZi No. 0991614012, the Regulations and Instructions for Simplified Registration of Class II Medical devices without a predicate approved for sale in Taiwan, issued by the Food and Drug Administration on November 16, 2010, clinical trial reports may be exempted from submission for registration and license if the following criteria are met (based on supporting documents submitted, and except for those requiring clinical trial in Taiwan as specified by the central health competent authority):

1. The expected performance of the product does not reveal race and ethnicity differences.
2. The intended use or indications claimed by this type of product has never been reported with serious adverse reactions or requested to be removed from markets overseas.
3. The differences between the product and other predicate products approved for sale in Taiwan can be proven by pre-clinical data (including testing) that these differences do not impact the safety and effectiveness of the product; or the applicant provides free sale certificates or documents in the United States (US) or the European Union (EU), the indications of the product fall within the scope approved by the US and the EU.During the course of application, if similar products are approved for sale in Taiwan, the applicant can discuss this case with the Administration. If, after assessment, the characteristics of the products are deemed similar and the risk level remains, the clinical trial report can be waived, and the application can be switched to a general medical device review. However, high-risk products always require clinical data in submission for registration and license, and the Medical Device Advisory Committee shall be consulted.

Web route directory: www.fda.gov.tw> Business Area> Medical Devices> Application for Certificates & Reference Letters> Medical Device Classification Inquiry  
Regulatory basis: According to Article 6 of the Regulations Governing the Management of Medical Devices, pharmaceutical firms or the public can pay fees and submit the following documents to the central health competent authority regarding the classification of medical devices and their management.  
Official processing time is 90 days.  
Application fee: NT$2000/copy  
Documents required: 

1. Medical device classification inquiry form 
2. Instruction for use (or catalogue) and its Chinese translation in details (including the instruction for use, function and working principle). 
3. Reference for classification of the product by the US or the EU.  
4. Any other information as defined by the central health competent authority.

The following table shows the breakdown of errors based on their frequency of occurrence, from high to low:
The most common error (68%~82%) is incomplete testing documents (i.e., testing reports to validate product safety and function, such as pre-clinical testing reports, plans and reports of important manufacturing process validation (e.g. sterilization) and quality control documents of manufacturer). It is recommended that applicants search for and refer to relevant domestic or foreign standards and guidelines during the R&D stage or first understand the testing items of other similar products. For imports, please fully communicate with the manufacturer overseas and ask the manufacturer to provide complete information to avoid delaying the process of the application. 
Lack of quality system (GMP or QSD) approved certificate and Certificate to Foreign Government issued by the manufacturing country, or incomplete or incorrect content in submitted documents. The preparation of these two documents requires a longer period of time. Delayed application and correction are often the reasons why an application for registration is not approved. Please apply as early as possible and confirm the completeness and correctness of the content.

Lack of relevant certificate of market approval or incomplete or incorrect content of submitted documents for applicants who plan to replace testing documents with the certificate of market approval issued by the US or the EU for class II medical devices. The preparation of these two documents also requires a longer period of time. Delayed application and correction, and unable to provide complete product testing documents  are often the reasons why an application for registration is not approved.

Safety and function of some class III medical devices cannot be verified only with testing documents, because they will be implanted in the human body for a prolonged period of time or are important life-support devices. Therefore, clinical trial reports are required. In this type of registration cases, applicants failing to provide clinical trial reports or the submission of incomplete reports will prevent us from verifying the safety and function of the products. Therefore, this is another reason why an application for registration is not approved. 

Incomplete or wrong instruction leaflets or labelings, including Chinese instruction leaflets, foreign original instruction leaflet (instruction manual or catalog), smallest packaging and label prepared by the manufacturer. This type of error is common, but it usually can be corrected in time, and thus an application for registration rarely fails for this reason.

Technical documents, including product structure, materials, specifications, performance, use, diagrams, etc. Unless manufacturers are not willing to provide such materials, this type of missing information can usually be corrected in time, and thus an application for registration is also seldom failed for this reason.
Errors related to authorization certificates, declaration and application forms can usually be supplemented quickly, and thus an application for registration is seldom failed for this reason.
 

It is not quicker. For applications for registration of class II medical devices, if there is a predicate product approved for sale in Taiwan, the applicants must submit documents supporting eligible sales in the US and the EU to be exempted from pre-clinical testing reports. However, exemption of pre-clinical testing is not applicable to class III medical devices or medical devices without predicated products approved for sale in Taiwan. Reviews in the EU and the US also take time.

Overall, it will not save domestically manufactured medical devices time if the applicants choose to acquire documents supporting sales in the US and the EU before having the devices registered in Taiwan. We suggest that applicants of domestically manufactured medical devices complete the registration in Taiwan first. If the applicants plan to expand in the US and the EU markets, they can apply for sales in the EU and the US simultaneously. Moreover, in order to encourage the development of the medical device industry in Taiwan, the Administration has promulgated the Key Principles for Medical Device Consultation.

Qualified applicants of innovative medical devices can apply to the Administration for consultation service during the R&D stage. The Administration will provide professional advice to help applicants shorten the pre-market preparation time. The industry is welcomed to use such counseling.

Ethylene oxide (EO) and radiation (Gamma ray) are commonly used to sterilize medical devices. Please refer to ISO11135 and ISO11137 respectively for the sterilization validation of these two standards. The Administration’s requirements for sterilization validation reports are summarized as follows:
The basis for sterilization validation shall be included in the report.
The report shall contain a description of the product to which the sterilization method is applicable, and the method shall meet the product which applicants intend to apply.

The report shall specify the set sterility assurance level (SAL).

The report shall explain the results of sterilization validation (e.g. results of bio-indicator or bio-burden tests) and how to verify that such sterilization methods can achieve the originally set SAL value. 
The validation reports should be issued recently (up to 2 to 3 years).
 

Please refer to the content of Attachment 3 of the Regulations Governing the Management of Medical Device for the medical devices requiring clinical trials in Taiwan for the application of registration as announced by the Food and Drug Administration. As to whether or not other medical devices require clinical trial in Taiwan when applying for registration, the applicants shall make the assessment in advance based on the product's characteristics (e.g. ethnic differences etc.).

If necessary, the applicants can prepare all relevant documents and consult with the Administration by letter in accordance with the FDA YaoZi No. 0920332729 issued by the Food and Drug Administration on December 2, 2003.

Because of safety and effectiveness concerns of high-risk products, such as coronary stents, carotid stents and hyaluronic acid implants, or applied products with specifications that are not totally the same as those products approved by the central health competent authority. Such products require clinical trial reports and relevant literature in addition to pre-clinical assessment. The Food and Drug Administration will review and confirm the clinical safety and effectiveness of the products before deciding whether to issue licenses.

Applications of a medical device clinical trial can be submitted to the Food and Drug Administration and Institutional Review Board for review at the same time. However, please note that the final version of the clinical trial Protocol and Informed Consent Form shall be approved by the Food and Drug Administration and Institutional Review Board.

According to Article 5 of the Pharmaceutical Affairs Act, The term "investigational medicaments" (drugs and medical devices) as used in this Act shall refer to the medicaments whose therapeutic performance and safety have not been verified and which are provided for exclusive use in the pharmacological assessment of toxicity on animals or in clinical trials. In addition, according to Article 2, Paragraph 2 of the Measures Governing Pharmaceutical Samples, if the drug (medical device) is for the purpose of research and trials only, the drug (medical device) can be applied as a sample. The medical devices approved by the central health competence authority for the purpose of clinical trial shall be labeled with the words 「臨床試驗用」 (clinical trial use only) or its equivalent English translation (research use only or investigational use only) in accordance with Article 19 of the Measures Governing Pharmaceutical Samples.

Medical devices for clinical trials shall comply with the provisions specified in Chapter 4 Medical Devices for Use in Clinical Trials of Part 3 Good Manufacturing Practices for Medical Devices in the Pharmaceutical Good Manufacturing Practice Regulations. In addition, the methods and facility of design, development, manufacturing, processing, packaging, storage and installation shall comply with Chapter 2 of Part 3 of the Pharmaceutical Good Manufacturing Practice Regulations.