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Appoint a License Holder in Taiwan
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Product Classification:Class I (low risk), Class II (medium risk)
Class III (high risk) -
QSD letter
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Product Registration
Medical Device Registration in Taiwan
TFDA announce Medical Devices Act on Jan. 15, 2020 for medical devices regulation independent from Pharmaceutical Affair Act.
Before starting application product approval, it is necessry to appoint a legal person as a license holder in Taiwan.
It is necessary to have a free sale certificate ready from the production nation.
There are two step to get product approval.
The first step is to prove that the production plant is in compliance with Taiwan quality mangment system regulation.
TFDA will grant a QSD letter.
The second step is to apply for product registration by providing technical documents for review.
These two steps could be applied in parallel. For Class III device, it is necessary
to provide documents in STED (Summary of Technical Documentation) format
according to Guidance published by Global Harmonization Task Force,GHTF.
- Step 1: QSD letter
It is necessary to apply for QSD letter in order to prove that the
physical manufacturer is in compliance with Taiwan GMP
(ISO 13485).You may provide quality system documents
for review instead of onsite inspection. There is fast track for EU member, Swiss, US and Japan.
some type of high risk device requires on site inspection. - Step 2: Product approval
Make sure that the product is allowed to be market on the original country
by providing the FSC (or CFG).Provide product dossier to prove that
the device performs as safe and effectiveness as the predicate device.
License Holder
We could be your license holder in Taiwan.
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CDRH | |
Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. The regulatory controls and marketing pathways are based on the risk of the device the regulatory controls needed to ensure reasonable assurance of safety and effectiveness. The marketing pathways include: Premarket Notification (510(k)), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA). | |
Four steps to bring a device to the market: | |
Step One: Classify Your Device and Understand Applicable Regulatory Controls | |
Device Classification Panel | |
Medical devices are categorized into one of three classes (I, II, or III), based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control, and class III devices subject to the most stringent regulatory control.
Class Risk Potential Harm Regulatory Controls Submission Type or Exemption
Class I : Lowest Risk, General Control by 510(k) or 510(k) Exempt
Class II: Moderate Risk, General and Special (if available) control by 510(k) or 510(k) Exempt
Class III: Highest Risk, General and PMA control by PMA
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Step Two: Select and Prepare the Correct Premarket Submission | |
The most common types of premarket submissions include:
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510 (k) Submission: Traditional, Abbreviate, Special | |
Some class I and most class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. | |
Step Three: Send your Premarket Submission to the FDA and Interact with FDA Staff During Review | |
Before sending your submission to the FDA, you should be aware of the following:
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Step Four: Comply with Applicable Regulatory Controls Including the Establishment Registration and Device Listing | |
Registration and Listing | |
Devices in all three classes (Class I, II, and III) are subject to general controls, unless exempted by regulations, which require, in part, that device facilities:
A device facility must register its establishment and list its devices with the FDA. Before registration , it is necessary to appoint an US Agent.
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US Agent | |
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. The responsibilities of the U.S. agent are limited and include:
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EU CE Marking |
EU Reguation MD Regulation
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Product Classification
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Medical Device Classification | |
Part I | |
Part II | |
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Health Canada |
Our service includes
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Who regulate medical device in Canada? | |
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada. | |
Medical Device Definition | |
The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. | |
Medical Device Classification | |
All medical devices have been categorized based on the risk associated with their use. This approach means that all medical devices are grouped into four classes with Class I devices presenting the lowest potential risk (e.g. a thermometer) and Class IV devices presenting the greatest potential risk (e.g. pacemakers). | |
Does a manufacturer have to obtain authorization prior to selling a medical device? | |
Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a Medical Device Licence. Although Class I devices do not require a Licence, they are monitored through Establishment Licences. | |
What is an establishment licence? | |
An Establishment Licence permits importers, distributors, and manufacturers of Class I devices who do not sell their products through a licenced importer or distributor, to operate in Canada. Establishment Licencing ensures that the TPD is aware of the identity of establishments that are selling or manufacturing devices. In addition, it requires establishments to provide assurance to the TPD that regulatory requirements related to post-production activities have been met. |
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How long does it take to review a medical device licence application? | |
Although the length of the review varies depending on the class of the device, Class III & IV Licence applications have a target review time of 75 days and 90 days respectively and Class II Licence applications have a 15 calendar day target. | |