This Regulation is established pursuant to Paragraph 3, Article 40 of the Pharmaceutical Affairs Act (hereafter referred to as the Act).

The registration of medical devices, and the change, transfer, extension, reissuance of damaged or lost medical device permit licenses shall conform to this Regulation. Matters not included in this Regulation are subject to other regulations, orders or proclamations made by the central health competent authority.

For all registrations mentioned in the preceding article, the applicant shall pay the application fee and submit completed application forms with all required documents pursuant to this Regulation to the central health competent authority for approval.
The application forms referred to in the foregoing Paragraph include application form for the registration and market approval of medical devices, application form for change of registration, application form for extension of permit license validity, affidavit, form for attaching outer box instruction label, and other form and document formats associated with the application procedures.
If the documents submitted for an application filed in accordance with this Regulation are not in traditional Chinese or English, a traditional Chinese or English translation shall be additionally provided.

When application for registration is approved, the applicant shall, in accordance with the permit license collection notice, pay the permit license fee, and collect the license by the designated deadline.
For medical devices requiring testing, the applicant shall, in accordance with the testing notice, pay the testing fee by the designated deadline, and submit said medical devices to the examination process with adequate samples for examination.

In any of the following situations, the application shall be disapproved:
1.Fees have not been paid in accordance with regulations, or attached materials are incomplete, or are inconsistent with the contents of the application.
2.The applicant has failed to collect the permit license or to submit samples for testing by the designated deadline, or the samples submitted for testing do not meet requirements.
3.The applicant has failed to publish, revise, or change the packaging, labeling, or instruction leaflet of the medical devices in accordance with regulations.
4.The medical device under application is considered to be hazardous to human health, or raises safety, quality, or efficacy concerns.
5.Other situations in nonconformity with this Regulation, other related laws or regulations, or proclamations of the central health competent authority.

When an application fails to comply with regulations and must be corrected, the applicant shall make correction by the deadline designated by the notification of the central health competent authority. The correction deadline shall be two months after the issue of the notification.
If the applicant cannot make correction by the deadline, the applicant is entitled to apply for an extension of the designated deadline for one month before the original deadline expires; such extension shall be granted only once.
If the applicant fails to make correction before the deadline, or fails to make correction before the expiration of the one-month extension period, the central health competent authority may perform review on the basis of existing information and accept or reject the application.

The manufacture and free sale certificates of the country of origin referred to in this Regulation are verifying documents issued by the highest health authority of the country where the imported medical device is manufactured. The content of such documents shall state the name and the address of the manufacturing factory, the name of the medical device, the specifications and model of the medical device, the circumstances of manufacture, and the certification of approval for domestic sale in that country. If it is confirmed that the medical device is not regulated by the highest health authority in the country of the manufacturer, said manufacturing and sales approval documents may be issued by the local health agency or an organization approved by Taiwan's central health competent authority.
With regard to the manufacture and free sale certificates in the foregoing Paragraph, if an imported medical device is commissioned to manufacture, and the device is not on sale in the country of the commissioned manufacturing factory, a free sale certificate issued from the country’s highest competent health authority of the commissioning company and a manufacture certificate issued from the country’s competent authority of commissioned manufacturing factory may be submitted instead of the foregoing manufacture and free sale certificate.
If an imported medical device is commissioned to be manufactured, the manufacture and free sale certificates in Paragraph 1 are allowed to be issued by respective highest health competent authority of the country either of the commissioning company or of the commissioned manufacturing factory.
The manufacture and free sale certificates in Paragraph 1 is allowed to be substituted by a certificate of manufacture issued by the government of the country where the imported medical device is manufactured and a certificate of free sale issued by the highest health competent authority of the United States of America, or any member state of the European Union.
The verifying documents in the four preceding paragraphs shall remain valid for two years after the date of issuance, and shall be notarized by Taiwan's embassy or consulate, representative office, other official office, or overseas organization in that country authorized by the Ministry of Foreign Affairs (hereafter referred to as the overseas representative organization of Taiwan). A Chinese or English translation shall be attached when the verifying documents are not in English, and the translation shall also be notarized.

A foreign original manufacturer authorization letter (hereafter referred to as authorization letter) mentioned in this Regulation means an authorized agent letter issued by a foreign original manufacturer of the imported medical devices, provided the following requirements are met:
1.The content of an authorization letter shall explicitly state that the original manufacturer authorizes the importer in Taiwan to apply for registration and market approval, and shall specify the commissioned or authorized company's name and address, and the name, specifications, and model of the medical device.
2.The authorization letter shall be valid within one year from its issuance date. If the authorization letter is not written in English, either a Chinese or an English version of translation of the authorization letter shall be submitted as well.
The authorization letter in the preceding paragraph may be substituted by the following document:
1.An authorization letter issued by the headquarter of the imported medical devices, that clearly indicates that the headquarter authorizes the importer to register, shall explicitly state the name and address of the manufacturing factory, and shall specify the commissioned or authorized company's name and address, and the name, specifications, and model of the medical device.
2.An authorization letter issued by the original manufacturer of the imported medical device to its foreign agent, and another authorization letter issued by the foreign agent that authorizes the importer to register, that shall explicitly state the name and address of the manufacturing factory, and shall specify the commissioned or authorized company's name and address, and the name, specifications, and model of the medical device.
The substitution in the preceding paragraph shall be valid within one year from its issuance date. If the substitution is not written in English, either a Chinese or an English version of translation of the substitution shall be submitted as well.

In Vitro Diagnostic Device (hereafter referred to as IVD) referred to in this Regulation is a medical device such as diagnostic reagents, instruments or systems used to collect, prepare, and test specimens from human body in order to diagnose disease or other conditions (including a determination of the state of health).

Class I, Class II, and Class III medical devices in this Regulation are determined in accordance with the Regulations for Governing Management of Medical Devices.

When applying for registration and market approval, change of registration, or extension of permit license validity for a medical device using bovine or ovine/hircine tissues, the applicant shall attach an explanation of animal raw material source control procedures and proof of raw material source from the original manufacturer in order to verify that the processes associated with the medical device and the ultimate finished product do not use any bovine or ovine/hircine product from the bovine spongiform encephalopathy (BSE) epidemic areas announced by the Council of Agriculture, Executive Yuan, and have not been contaminated by BSE pathogens.
For the applications conforming to the announcement from the central health competent authority regarding the exemption from submitting the documentation in the preceding paragraph after considering the international regulatory guidelines for controlling bovine or ovine/hircine tissues in accordance with the risk of contamination of the tissues by BSE pathogen, this provision shall not apply.

Pre-clinical testing and the test specifications and methods, the original test records, and the test reports for the quality control conducted by the original manufacturer, referred to in this Regulation, include documents of safety and functional testing for ensuring the claimed indication for use, structure, materials, design, and quality of the product.
For applying the registration, the change of specification or indication for use for a Class II medical device with a predicate product approved to market by the central health competent authority, documents in the preceding paragraph may be substituted by any of the following document:
1.A certificate of market approval issued by the government or other competent authority of the United States of America, and any member state of the European Union. The efficacy and indication of the device should be consistent with those described in the above-mentioned certificate.
2.An affidavit of pre-clinical testing document in conformity with the proclaimed items of the central health competent authority.
Application document in the preceding paragraph exempted from submitting shall be kept in the plant for possible inspection. The central health competent authority may order its submission when necessary.
The commissioned laboratory responsible for inspection in Paragraph 1 shall carry out biocompatibility, electrical safety, and electromagnetic compatibility (EMC) tests in conformity with any of the following:
1.ISO/ IEC 17025.
2.Good Laboratory Practice for Nonclinical Laboratory Studies (GLP).