Medical Devices Act and Regulations Governing Issuance of

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Yu Ping Hsieh, ReviewerDivision of Medical Devices and Cosmetics

Taiwan FDA

Medical Devices Act and Regulations Governing Issuance of Medical Device

License, Listing and Annual Declaration (focus on abbreviated review)

Oct. 14, 2021

9th Joint Conference of Taiwan and Japan on Medical Products Regulation

General Overview of Medical Devices Act

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Basis of Medical Devices Regulation

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Medical Devices Act

• Enforcement Rules of Medical Devices Act• Regulations Governing Issuance of Medical Device

License, Listing and Annual Declaration• Regulations Governing the Classification of Medical

Devices• Regulations for Management of Medical Devices

Technicians• Regulations Governing Contract Manufacturing of

Medical Devices• Regulations of Medical Device Tracking Management• Regulations on Good Clinical Practice for Medical Devices• Regulations for Medical Device Recalls…etc

Act

Regulation

Guidance

• Standards for Preclinical Testing of Medical Devices• Principles of Compiling Chinese Instructions for Medical Devices• Guidance of Cybersecurity for Medical Devices Manufacturers …etc

Regulatory Framework for Total Product Life Cycle in MDA

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Clinical Trial Regulation

Listing & Registration

Manufacture &

Sale RegulationAdvertisement

Regulation

Supervision &

Prevention

Inspection

& Enforcement

Premarket Control Postmarket Surveillance

Chapter IVManagement of Medical Device Clinical Trials

Chapter IIIListing and Registration and Market Approval of Medical Devices

Chapter IIManagement of Manufacturing and Sale

Chapter VManagement of Medical Device Advertisements

Chapter VISupervision and Prevention

Chapter VIIInvestigation and Interdiction

Definition of Medical Devices

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Medical Devices Act, Article 3：The term "medical devices", as used in this Act, shall refer to

instruments, machines, apparatus, materials, software, reagents forin vitro use, and related articles thereof, whose design and useachieve one of the following primary intended actions in or on thehuman body by other than pharmacological, immunological,metabolic, or chemical means:

1. Diagnosis, treatment, alleviation, or direct prevention ofhuman diseases.2. Modification or improvement of the structure and functionof human body.3. Control of conception.

Risk Based Classification of Medical Devices

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Regulations Governing the Classification of Medical Devices,Article 2 and Article 3：Medical devices are classified into 16 categories according totheir function, intended use, operating instructions, andworking principle, depending on the applicable medical specialty；and they are classified into 3 classes according to their risk level.

Clinical chemistry

and clinical toxicology

devices

Cardiovascular devices

General, plastic

surgery, and dermatology

devices

Ophthalmic devices

Hematology, pathology,

and genetics devices

Dental devices

General hospital and personal use

devices

Orthopedic devices

Immunology and

microbiology devices

Ear, nose, and throat

devices

Neurological devices

Physical medicine devices

Anesthesiology devices

Gastroenterology and urology

devices

Obstetrical and

gynecological devices

Radiology devices

Risk level

Low risk

Medium risk

High risk

Class I

Class II

Class III

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration

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Documents required for registration

Low risk High risk

Class 1 Class 2

• Administrative documents

• Basic documents• Technical documents• Clinical evidence

information


• Basic documents• Technical documents• Clinical evidence

information

Class 3

QMS/QSD QMS/QSD QMS/QSD


• Basic documents• Technical documents

(few product items)

QMS: Quality management systemsQSD : Quality System Documentation

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• Listing (product items announced by the central competent authority)

or

Framework of Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration

⚫ Chapter 1 General Provisions

⚫ Chapter 2 Registration and Market Approval of Medical Device andIssuance of License

⚫ Chapter 3 Change, Re-issuance, or Replacement of License

⚫ Chapter 4 License Extension

⚫ Chapter 5 Listing and Annual Declaration

⚫ Chapter 6 Supplementary Provisions

➢ Appendix 1： Documents and information that shall be submitted for an application of

registration and market approval to manufacture or import Class 1 medical devices


registration and market approval to manufacture or import Class 2 or Class 3 medical

devices

➢ Appendix 3： Applicable Product Items for Class 2 Medical Device Product Comparison and

Preclinical Test Data Conformity Statement


change, re-issuance, or replacement of medical device license

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Alternative pathway for simplifying technical documents-A

Appendix 2: Documents and information that shall be submitted for anapplication of registration and market approval to manufacture or importClass2 or Class 3 medical devices:

Instructions:

7.Test specifications and methods of preclinical testing and quality control conducted by the

original manufacturer, the original test records, and the test reports:

(2)For Class 2 medical devices with predicate device(s) that have been approved for marketing

by the central competent authority, this document may be replaced by one of the following

documents:

①Marketing approval certification document issued by the government of a country that has

established technical cooperation agreement with the Republic of China (Taiwan) for the

premarket review of medical devices, as well as Essential Principles (EP) of Safety and

Performance of Medical Devices and Summary Technical Documentation (STED).

②Affidavit of preclinical testing conformity for medical device that is a product announced

by the central competent authority whose manufacturer has a predicate device of the same

classification and approved for marketing by the central competent authority.

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Affidavit of preclinical testing conformity for medical device

⚫ Same manufacturer has a predicate device of the same classification

and approved for marketing by the central competent authority.

⚫ The license status of the predicate device is accepted when it is either

valid or expired.

⚫ Announced 8 product items are applicable:

✓ Infrared ear thermometer

✓ Clinical electronic thermometer

✓ Surgical drape

✓ Surgical gowns

✓ Infrared forehead thermometer

✓ Surgical lamp

✓ Static electric therapy apparatus

✓ Infrared lamp

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⚫ Information of the similar

device(s) from the same

manufacturer with the same

classification number in the same

class which has/have received

market approval from the

MOHW:

醫療器材許可證字號

Medical device License

Number

產品中文名稱

Product Name (Chinese)

產品英文名稱

Product Name (English)

規格/型號

Model or type

⚫ Product applied for registration and the Declaration of Pre-clinical testing conformity:

產品中文名稱 Product Name (Chinese)

產品英文名稱 Product Name (English)

規格/型號Model or type

臨床前測試符合性聲明(請依附表、「醫療器材品項及其應符合之臨床前測試基準或標準」內容填列，以“

及”列出者須全部符合，以“或”列出者可擇ㄧ符合；如基準或標準中未訂有規格者，須另提供廠規或與類似品比對之數據資料)Declaration of Pre-clinical testing conformity(Please fill in the form referring to the guidance/standards listed in the Table of the Annex “Conformity Assessment of Medical Device to the recognized Standards and Guidance”. When quoted as “and”, all the stated information must be supplied accordingly; when quoted as “or”, it is sufficient to provide one of the stated information. If there are no specifications given by the stated guidance/standards, then the data based on the manufacturer’s own specification or the comparative data comparing the device with a predicate device must be provided).

一、請擇ㄧ勾選填列：check on one box only:

□符合公告之臨床前測試基準(依C欄所列，請詳列基準名稱)

The device stated above conforms to the guidance published by the MOHW (please fill in the corresponding guidance referring to the “Guidance for pre-clinical testing” in column C of the Annex)._____________________________________

□符合本項產品對應之功能性及安全性標準(依D兩欄所列，請詳列標準名稱及年份)

The device stated above conforms to the recognized performance/safety standards (please fill in the corresponding standards and the published years referring to the “Recognized Standards” in column D of the Annex).

1. 功能性(垂直)標準/List of performance standard (standard/year):

_________________________________________1. 共通安全性(水平)標準/List of safety standard (standard/year):

_________________________________________

二、請擇ㄧ勾選填列： check on one box only:

□前列基準/標準中已訂有全項規格。The applied guidance/standards listed above provide all the acceptance criteria and specifications.

□前列基準/標準中未訂有規格者，另提供廠規或與類似品比對數據備查，附於後。There are no specifications given by the stated guidance/standards. Instead, data based on the manufacturer’s own specification or the comparative data comparing the device with a predicate device are attached in case of review.

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A.品項名稱Device name

B.分級分類代

碼

Classification

number

C.對應臨床前

測試基準

Guidance for

pre-clinical

testing

D.對應標準

1.功能性(垂直)標準

Essential performance (vertical)

standards

2.共通安全性(水平)標準

General Safety (horizontal)

standards

紅外線耳溫槍

(Infrared ear thermometer)

J.2910 紅外線耳溫槍臨床

前測試基準

1. ISO 80601-2-56:2017/Amd 1: 2018

Medical electrical equipment - Part 2-56:

Particular requirements for basic safety and

essential performance of clinical

thermometers for body temperature

measurement；或

2. ASTM E1965 - 98(2009)

Standard Specification for Infrared

Thermometers for Intermittent

Determination of Patient Temperature；或

3.中華民國國家標準CNS 15042 間歇性測定

患者體溫之紅外線體溫計(2007)

1. IEC 60601-1:2005+Amd 1:2012 Medical

Electrical Equipment – Part 1: General

Requirements for basic Safety and

Essential Performance；及

2. IEC 60601-1-2:2014 Medical electrical

Equipment - Part 1-2: General

requirements for basic safety and essential

performance – Collateral Standard:

Electromagnetic disturbances –

Requirements and tests；及

3.產品與人體接觸部位(如探頭、護套等)：

ISO 10993-1:2018 Biological evaluation

of medical devices - Part 1: Evaluation

and testing within a risk management

process

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⚫ Product items of the medical device & the guidance/standard for pre-

clinical testing

Appendix 2: Documents and information that shall be submitted for anapplication of registration and market approval to manufacture or importClass2 or Class 3 medical devices:

Instructions:

7.Test specifications and methods of preclinical testing and quality control conducted by the

original manufacturer, the original test records, and the test reports:

(3)For Class 2 medical devices in Appendix 3, if the same manufacturer has a predicate

device approved for marketing by the central competent authority that has the same

product classification and its license is still within the validity period, this document

may be replaced by the Class 2 medical device product comparison and preclinical test

data conformity statement.

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Alternative pathway for simplifying technical documents-B

Class 2 medical device product comparison and preclinical testdata conformity statement

⚫ Same manufacturer has a predicate device of the same classification

and approved for marketing by the central competent authority.

⚫ The license of the predicate device is still within the validity period.

⚫ 34 product items: see Appendix 3.

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產品資訊Product Information

新申請產品New Application

Product

比較產品Comparison

Product

異同處比對說明Comparative Explanation

for Differences and

Similarities

1中英文品名Chinese and English Name of Product

--

2衛生福利部核准字號License Number Approved by Ministry of Health and Welfare

--

3

製造廠名稱/地址Manufacturer Name/Address

(註：請填寫製造廠)

(Note: Please fill in the actual manufacturing facility.)

--

4產品類別Product Category

5

產品敘述效能/適應症/預期用途Product Description

Efficacy/Indication/Intended Use

6工作/設計原理/方法Work/Design Principle/Method

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材料/成分配方Material/Ingredient Formula

(註：適用體外診斷試劑及接觸人體之醫療器材)

(Note: Applicable to medical devices that are IVD reagents and contact human

body.)

8規格、型號Model or Type

9使用/操作人員資格User/Operator Qualification

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新申請產品與比較產品之差異處，不影響新申請產品臨床使用安全及有效性之說明Explanation that differences between the new application product and the

comparison product do not affect safety and effectiveness for clinical use of the

new application product

⚫ Comparative table of differences and similarities between the new application product and the comparison product:

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⚫ Safety standards that the new application product conforms to:

⚫ Performance standards that the new applicationproduct conforms to and summary ofperformance test items:

序號

Order

No.

評估項目

Evaluation Item

符合標準/製造廠規範

Conformity Standard /

Factory Specification

報告編號

Report No.

1電性安全

Electrical safety

2電磁相容性

Electromagnetic compatibility

3

生物相容性Biocompatibility(請逐項列出評估試驗項目)

(Please list one by one the evaluation test

items.)

3.1…

3.2…

4軟體確效

Software validation

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滅菌確效

Sterilization validation

(註：請說明使用之滅菌方法)

(Note: Please explain the sterilization

method used.)

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其他適用之安全性標準

Other applicable safety standards

(請廠商依需求自行增加項)

(Please have the firm voluntarily add items

according to needs.)

序號

Order

No.

測試項目

Test Item

符合標準/製造廠

規範

Conformity

Standard /

Factory

Specification

報告編號

Report No.

1如:安定性

Example: Stability

2

其他適用之評估

試驗……

Other applicable

evaluation tests…

(請廠商依需求自行

增加項)

(Please have the firm

voluntarily add items

according to needs.)

3

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Thank you for your attention!

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