Appoint a License Holder in Taiwan
Product Classification：Class I (low risk), Class II (medium risk)
Class III (high risk)
QSD letter
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.

US FDA
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

Step Two: Select and Prepare the Correct Premarket Submission
The most common types of premarket submissions include: 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request HDE (Humanitarian Device Exemption)
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: Medical Device User Fees: There is a user fee associated with the submission of certain marketing applications. Please see Medical Device User Fees. Small Business Determination (SBD) Program: A business that is qualified and certified as a "small business" is eligible for a substantial reduction in most of these user fees. Please see Reduced Medical Device User Fees: Small Business Determination (SBD) Program. eCopy: Premarket submissions must include an electronic copy (eCopy) on a compact disc (CD), digital video disc (DVD), or a flash drive. Please see eCopy Program for Medical Device Submissions.

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: register their establishments and list the medical devices they market with FDA; manufacture their devices in accordance with Good Manufacturing Practices; label their devices in accordance with labeling regulations; and cannot be adulterated or misbranded. If a device is exempted from one of the general controls, such exemption is stated in the classification regulation for that device. A device facility must register its establishment and list its devices with the FDA. Before registration , it is necessary to appoint an US Agent.

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: assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States, assisting FDA in scheduling inspections of the foreign establishment and if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

	EU CE Marking
EU Reguation MD Regulation IVD Regulation Directive 93/68/EEC: CE marking Directive 93/42/EEC: Medical Devices Directive 98/79/EC: In vitro diagnostic medical devices Directive 2000/70/EC: medical devices incorporating stable derivate of human blood or human plasma Directive 2001/104/EC: amendment Directive 2007/47/EC: amendment harmonised standards under Directive 93/42/EC for Medical devices harmonised standards under Directive 98/79/EC for In vitro diagnostic medical devices
Product Classification MD：Class I, Class II a, Class II b, Class III IVD：Class A, Class B, Class C, Class D Preclinical Study Counseling Technical construction File preparation Acquire ISO 13485 and EC certificate by notify body Appoint an authorized representative in EU
Medical Device Classification
Part I
Part II

	Health Canada
Our service includes Product Classification：Class I, Class II, Class III, Class IV CAMCAS ISO 13485 certificate Preclinical Study Counseling Submission package preparation Response to Reviewer’s questions
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.

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.

​License Holder

License Holder