Registration Process of Medical Products (Class II & III) in Taiwan
Due to the complex registration process and strict regulatory supervision of medical products worldwide, medical product manufacturer shall be able to understand the local registration process and regulatory affairs exactly, so that a market success of the product can be achieved.
Acronym / Description
TFDA: Taiwan Food and Drug Administration
DOH: the Department of Health
MOHW: the Ministry of Health and Welfare
GMP: Good Manufacturing Practice
QSD: Quality System Documentation
WD: Working day
CFS: Certificate of Free Sale
CFG: Certificate to Foreign Government
As in many other countries, the registration process of the medical device in Taiwan is regulated by the ministry of food and drug, which is named the Taiwan Food and Drug Administration or shortly known as TFDA. TFDA was established in 2010 under the country’s Department of Health (DOH) to act as the competent authority overseeing food, drugs, medical devices, and cosmetics. In 2013, the DOH was reorganized into the Ministry of Health and Welfare (MOHW). TFDA regulates medical devices in 17 categories according to their risk-based classifications. TFDA also adopted its own good manufacturing practice (GMP) for quality systems, which is harmonized with ISO 13485. Similar to regulators in many other Asian countries, TFDA requires also a local qualified distributor to act as the applicant for quality system review and product registration, if the manufacturers don’t have a local representative office in Taiwan.
Foreign registrants must ensure that their Taiwan Agents are legally established in Taiwan, and that they hold pharmaceutical sales license certifications. Key duties Taiwan Agents perform on behalf of registrants include:
- Submitting all necessary registration documentation to TFDA;
- Securing QSD approval letters;
- Ensuring that registrants’ QSD licenses and device registrations are kept up to date;
- Managing any serious adverse event (SAE) reporting involving registrants’ devices;
- Filing import authorization requests to TFDA for each distributor a registrant uses in Taiwan.
Quality Management System requirements
The quality system documentation (QSD) review is the precondition to prepare for the product registration process, which the manufacturers of class II and III medical products shall consider at the very beginning of preparing phase for the product registration. For foreign manufacturers, in addition to the options of on-site inspection and full QSD review, TFDA provides two additional modes to simplify the review process:
1. Simplified mode for US factories compliant to ISO 13485
For manufacturers located in the US and certified to ISO 13485, the applicant can provide a valid ISO 13485 certificate, Establishment Inspection Report (EIR), and Certificate to Foreign Government (CFG) issued by the US FDA to apply under this simplified mode.
2. Simplified mode for European Union factories
For manufacturers located in the EU region (as well as Switzerland and Liechtenstein) that have ISO 13485 certificates issued by one of several TFDA recognized Notified Bodies, based on the current Technical Cooperation Program (TCP) II notice, applicants can provide their manufacturer’s ISO 13485 certificate, inspection reports, and Certificates of Free Sale (CFS) to apply under this simplified mode. Upon approval, the manufacturer will receive a QSD approval letter valid for three years. From January 1, 2018, manufacturers must apply for on-site inspections if they produce devices within the scope of TFDA device classification number E.3925 – Replacement heart valve. This rule applies to manufacturers that are newly established, relocated, expanded, and re-established. From January 1, 2019, the rule will apply to devices within the scope of device classification number E.3450 (Vascular graft prosthesis), M.3400 (Keratoprosthesis), and N.3025 (Passive tendon prosthesis).
TFDA regulates medical devices in three classifications (class I, II, and III) according to increasing risk levels. The medical product manufacturers can determine the product classification by using the database offered by TFDA, which is similar to the system used by the US Food and Drug Administration.
Some typical examples for the classifications:
Class 1 – Surgical microscope and accessories
The surgical microscope and its accessories are devices powered by alternating current and used to magnify the field of view of the surgical field during surgery.
Class 2 – Diagnostic intravascular catheter
Diagnostic intravascular catheters are devices used to record blood pressure in the heart, collect blood samples, and introduce substances into the heart and blood vessels. Such equipment usually includes right heart catheters, left heart catheters, and blood photography catheters, among others.
Class 3 – Arterial embolization device
Arterial embolization device is an intravascular device used to control internal bleeding or prevent arterial blood from flowing to certain abdominal tumors (such as nephropathy, hepatoma) and malformed arteries and veins. This equipment is not available for intracranial arteries.
Registration process & timeline
The registration process and timeline are described as following table:
Requirements for registering application documents
Required application documents include:
- Completed application forms,
- Copies of labeling and IFU (translated to Chinese),
- Device information, including structure, materials, specifications, performance, technical drawings,
- Summary of basic specifications and technical documents for the safety and efficacy of medical equipment,
- Copies of manufacturer and dealer license,
- Declaration letter,
- Market approval in the country or region where the manufacturer bases,
- Proof of QSD application submission,
- Product testing reports, and preclinical testing data (if applicable).
For detailed statements of required documents see the checklist offered by TFDA. Testing conducted outside Taiwan is usually accepted by the TFDA. (Class I and II devices approved for sale in the US and Europe qualify for a Simplified Application Route and do not require a review of preclinical testing results by the TFDA.)
Requirements on the license change
The manufacturers are allowed to apply for a license change if there are any changes in product or registration information, the following table shows the required documents for license change application according to allowed changed items:
Links & Source
Laws & Regulations Database of The Republic of China
Medical Device Database
- For product classification
Online application of TFDA
- Registration guidance
- Links for downloading application forms
- Contact of responsible
Centre for Drug Evaluation, Taiwan
- Official regulatory affairs consulting