TFDA
Medical Device Registration in Tawian
Regulation: Medical Device Act

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

TFDA announce Medical Devices Act on Jan. 15, 2020 for medical devices regulation independent from Pharmaceutical Affair Act. Before starting application medical device 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 devices require on site inspection.

• Step 2： Product approval

Make sure that the product is allowed to be market at the original country by providing the FSC (or CFG). Providing 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.

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 in clude: 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:

1. register their establishments and list the medical devices they market with FDA;
2. manufacture their devices in accordance with Good Manufacturing Practices;
3. label their devices in accordance with labeling regulations; and
4. 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 devicesthat 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).

Medical Device EU Reguation 

• MD Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )
• IVD Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

Step 1: Medical Device Classification

• MD：Class I, Class II a, Class II b, Class III 
• IVD：Class A, Class B, Class C, Class D

Please go to EUDAMED system to find European Medical Device Nomenclature (EMDN) for your devices. The Classification Rules please follow MDR 2017/745 / IVDR 2017/745 Annex VIII.

Step 2: Prepare Technical Documentation

Prepare tehcnical documentation according to Regulation 2017/745 or Regulation 2017/746 Annex I, Annex II and Annex III.  

Step 3: Prepare EU Declaration of Conformity or Acquire ISO 13485, MDR certificate.

Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the confromity of their products by issuing the EU declartaion of conformity after drwaing up the technical documentation. if those devices are palced on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manfuacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited.

Step 4: Appoint an Authorized representative in EU member state and Register in EUDAMED

Before placing a device, other than a custom-made device, on the market, manufacturers shall appoint an authroized representative in EU and submit information to the EUDAMED system in registration of manufacturers. After having verified the data entered, the competent authority shall obtain a single registration number (SRN) from the electroinc system and issue it to the manufacturer, the authroized representative or the importer. The Unique Device Identification (UDI system) on Label is required for the identification and facilitate the traceability of devices, other than custom-made and investigation devices, and shall consist of UDI-DI and UDI-PI. 

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.

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Medicines & Healthcare Products 
Regulatory AgencyRegulation in Great Britain

UK MDR 2002
all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market

• if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration.
• CE marking will continue to be recognised in Great Britain until 30 June 2023
• certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
• Legislation that applies in Great Britain Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period, gave effect in UK law to the directives listed below:

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
This means that the Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.

Registrations in Great Britain

All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA. In addition, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the Great Britain market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.

The MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, they must appoint a UK Responsible Person. This UK Responsible Person will then assume certain responsibilities on behalf of the manufacturer as described below in the guidance for UK Responsible Persons, including registering the device with the MHRA.

UK Responsible Person

The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. In summary, in addition to the above registration requirements, the UK Responsible Person must:

• ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
• keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
• in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
• where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
• where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
• cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
• immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
• if the manufacturer acts contrary to its obligations under these Regulations: terminate the legal relationship with the manufacturer; and inform the MHRA and, if applicable, the relevant Approved Body of that termination.

Regulation of medical devices in Northern Ireland

The rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland). The Government has introduced new legislation to make changes to how the Northern Ireland Protocol will apply.  There is a requirement, in certain cases, to register devices with the MHRA and to have a UK Responsible Person if the manufacturer is based outside the UK, as set out below.The following requirements apply to manufacturers wishing to place medical devices on the Northern Ireland market:

• Since 26 May 2021, the EU MDR has applied in Northern Ireland. The EU IVDR will apply in Northern Ireland from 26 May 2022
• CE marking is required for the Northern Ireland market. In addition, the UKNI indication is required if a UK Notified Body undertakes mandatory third-party conformity assessment
• certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the MHRA
• all custom-made devices must be registered with the MHRA within 28 days of being made available on the Northern Ireland market
• when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative
• IVD manufacturers based outside the UK may be required to have a UK Responsible Person in place to act as a regulatory point of contact within the UK and comply with the registration requirements.