แนวทางการขึ้นทะเบียนและมาตรฐานที่เกี่ยวข้องกับผลิตภัณฑ์...

แนวทางการขึ้นทะเบียนและมาตรฐานทีเ่กี่ยวข้องกับผลิตภัณฑ์เครื่องมือแพทย์นายธเนศ วิริยะเมธานนท์

วิศวกรชีวการแพทย์ กองควบคุมเครื่องมือแพทย์ ส านักงานคณะกรรมการอาหารและยา

Outline

1) แนวทางการขึ้นทะเบียนผลิตภัณฑ์เครื่องมือแพทย์

2) มาตรฐานในเบ้ืองต้นที่เกี่ยวข้องกับผลิตภัณฑ์เครื่องมือแพทย์

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Medical device regulation in Thailand (In the present)

What is regulated as a Medical Device?

Definition of a Medical Device in accordance to The Medical Device Act (2nd edition) 2019

Any instrument, apparatus, accessory, machine, implant, in vitro reagent andcalibrator, software, material or other similar or related article intended by themanufacturer or product owner to be used alone or combination, for humanbeings or animals for the specific purpose(s)Achievement of the purposes according to the above in or on the human or animal

bodies must not intend by pharmacological, immunological or metabolic means.

Note. The Medical Device Act (2nd edition) 2019 has been implemented since May 1, 2019

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Entering the Thailand Market

1. Establishment Licensing &

Seller Licensing

2. Product Registration

3. Post-market Obligations

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Establishment licensing• Manufacturer’s license• Importer’s license

Local companies who manufacture or import are required to be licensed by Thai FDA

Seller licensing

Local companies who sale HIV Test Kits for Diagnostic use, Blood bag for human, Ophthalmic

viscosurgical devices or Tooth bleaching productare required to be licensed by Thai FDA

Product registration

Registration of medical device for supply in Thailand

Pre-Market controls: Establishment & Seller Licensing

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MEDICAL DEVICE REGISTRATION AND APPROVAL IN THAILAND

Medical device in Thailand is classified into 3 categories namely Group I, II and III.Unlike the risk classification adapted by most countries, group I devices in Thailand are considered the riskiest medical device and group III devices are considered the lowest risk device.

ClassificationType of

RegulationProduct lists Documentation

Group ILicensed

Medical DevicesCondom, Surgical glove, HIV Test Kits for Diagnostic use,

Contact Lens, Blood bag for human, HIV self-testing, Filler

CSDT

Group IINotified

Medical Devices

Physical therapy device, Alcohol detector, Implanted Silicone Breast Prosthesis, Breast enhancement, Methamphetamine Test Kits,

Ophthalmic viscosurgical device, Dialysate concentration for hemodialysis, Tooth bleaching products, Contact lens care

products, Alcohol Pad, Alcohol Gel

Group IIIGeneral

Medical Devices

Medical devices that does not fall under group I and group II can be classified under group III.

This group includes about 90% of medical devices

Do not prepare CSDT.Only the product

description/information, product catalogue, and the Certificate of Free

sale

Pre-Market controls: Product registration

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Only General medical device can

submit via online portal SKYNET

• Online submission

Licensed and Notified medical device

can submit via One Stop Service Center

(OSSC)

• Paper-based document submission

1 2

Pre-Market controls: Submission of Applications

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Post-market obligations

Vigilance requirements

Keep supply & complaint records

Advertising

• the registrant of the establishment has to prepare a report on the abnormal performance orany AE or Device defect of the medical device, and a report on its FSCA

• Traceability

• Thai FDA will review and consider an advertising application before issuing a license

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Medical device regulation in Thailand (In the future)

Medical device regulation reform update (In the future)

1. Risk-classification Risk-based classification rules are for medical device.

2. Listing For medical device class 1 can exempt Certificate of Free Sale (CFS)

3. GroupingThe medical device can be grouped together and submitted in one productregistration application.

4. CSDT Submission Voluntary

Manufacturer or importer medical device Class 2 to 4 can submit voluntaryCSDT document.

5. Concise EvaluationThe concise evaluation route applies to medical devices that have beenapproved in at least two of the big five countries and marketed history atleast one year.

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1. Risk-classification

Risk-based approach, in line with ASEAN Medical Device Directive (AMDD) and Medical Device Act (2nd edition) 2019

Medical Devices were categorized into 4 risk classes, aligned with the international rule-based classification system

RegulationOversight

1 2 3 4Degree of Risk

Wheel

chair

Surgical

gloves

Condom

Blood bags

with

anticoagulation

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High risk

Moderate-high risk

Low-moderate risk

Low risk

Class 4

Class 3

Class 2

Class 1

Licensed Medical devices

Notified Medical devices

Listing NEW

1. Risk-classification

IVD Non -IVD How to regulate

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1. Risk-classification

References : Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices and Non-In Vitro Diagnostic Medical Devices

Specia

l

InvasiveNon-invasive Active

Total 16 classification rules, 4 major categories of Non-IVD

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2. Listing

*** First phase ***

● Cover medical device class 1 - 4

● Medical device for animals

***Exempt medical devices which were issued as licensed and notified medical devices

ร่าง ประกาศกระทรวงสาธารณสุขเรื่อง ก าหนดกลุ่มเครื่องมือแพทย์หรือเครื่องมือแพทย์ที่ผู้ผลิตหรือผู้น าเข้าต้องจดแจ้ง พ.ศ. ….

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3. Grouping

Grouping

Effective since

October, 2018

The medical device can be grouped

together and submitted in one productregistration application.

Single

System

Family

Set

Non-IVD

Single

System

Family

IVD Test kit

IVD

IVD Cluster

(Thai Version)

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4. CSDT Submission Voluntary

CSDT Submission Voluntary

Effective since September, 2019

Manufacturer or importer medical device Class 2 to 4 can submit voluntary CSDT document

ประกาศส านักงานคณะกรรมการอาหารและยา เร่ือง หลักเกณฑ์การประเมินเอกสารแบบเต็ม (full evaluation) และแบบย่อ (concise evaluation)

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5. Concise Evaluation

Evaluation process for CSDT

Full evaluation

The concise evaluation route applies to medical devices that have been approved inat least two of the big five countries including Australia, Canada, European Union,Japan, United States and marketing history at least one year.

Concise evaluation

Effective since September, 2019

Note. In the future, the concise evaluation criteria will be improved.

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How to medical device regulation in the future

Product registration

Medical device class 1 for human beings or animals Medical device class 2 - 3 Medical device class 4

Listing● Exempt Certificate of Free Sale ● Self-declaration

CSDT CSDT

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Lifecycle of a medical device

Common problems of researchers towards commercialization

● Lacking Regulatory Strategy Review○ Product classification

(Drugs / Medical devices / Cosmetics / Consumer products)○ Standard requirement

● Lacking Commercial and Market Strategy Review○ Market validation

● Restrictions of institutional regulations○ A university Spin-off

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Concept/FeasibilityDesign Validation

/ PreclinicalClinical Market approval Post market

Managementstandards

Regulatoryrequirements

ProductStandards

Quality management

system(ISO 13485)

Risk management(ISO 14971)

Product registration

Establishment registration

Biocompatibility testing

(ISO 10993)

Electrical safety(IEC 60601)

Regulatory review

Market review

PersonnelTraining

The medical product development lifecycle

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Concept/FeasibilityDesign Validation

/ PreclinicalClinical Market approval Post market

Managementstandards

Regulatoryrequirements

ProductStandards

Product registration

Establishment registration

Biocompatibility testing

(ISO 10993)

Electrical safety(IEC 60601)

Regulatory review

Market review

PersonnelTraining

Fail

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The medical product development lifecycle

Quality management

system(ISO 13485)

Risk management(ISO 14971)

Basic standard related to medical devices

Horizontal Standards vs. Vertical Standards

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● Consensus standards ensure safety & efficacy, suggest testing methods, acceptance criteria, and processes to address areas such as risk management and usability. These types of standards include biocompatibility, sterilization, materials, software and informatics.

● “Horizontal Standards”○ Not product code specific○ Cover many different device types across various

classification panels● “Vertical Standards”

○ Product code specific○ Apply only to a specific type of device

Group of standards

Manufacture

Quality Management System: QMS

Product

Consensus standards

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Examples of Standards

QMS

Product

• ISO 13485 - Quality management systems - Requirements for regulatory purposes

• ISO 14971 - Application of risk management to medical devices

• ± Good Manufacturing Practice (GMP)

• Material (ASTM Standard)

• Biocompatibility (ISO 10993)

• Sterilization

• Medical Electrical Equipment (IEC 60601 Series)

• Software Validation (IEC 62304)

• Usability (IEC 62366)

• Clinical Evaluation (MEDDEV 2.7/1 rev 4) for Non-IVD

• IVD Performance Evaluation (EN 13612) for IVD

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Standard

ต้องด าเนินการทดสอบจาก Lab ที่ได้การรับรอง ISO 17025 / GLP

• ISO 10993• ISO 11737• IEC 60601• IEC 62304

…

• ISO 14971• ISO 11135• MEDDEV 2.7.1

…

Comply with standard

Examples of Standards

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How to search guidance from USFDA

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents

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Example product guidance from USFDA

Example

30Source: https://www.fda.gov/media/78369/download

Example

Example product guidance from USFDA

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Example

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Example product guidance from USFDA

Example

Example product guidance from USFDA

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Example

Example product guidance from USFDA

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https://www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels

● Medical devices are classified and described in USFDA Title 21 CFR 862-892

● Over 1,700 different devices

● 16 medical specialty "panels"○ e.g. as Cardiovascular devices or

Ear, Nose, and Throat devices

● General description includes:○ intended use○ device class (i.e., Class I, II, or III)

888 - Orthopedic

How to search recognized consensus standards from USFDA

Regulation Code (USFDA database)

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§ XXX.XXXX

7-digit Regulation Code

§ 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Classification Regulation Details

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Intended use + other descriptors

Product Code (USFDA database)

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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

Enter 7-digitRegulation number

Recognized consensus standards (USFDA database)

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Recognized consensus standards

Summary process (In the future)

Design & Planning

Develop Prototype

ISO 13485

Pre-Clinical

Clinical

CSDT

จด สผ.

ขึ้นทะเบียนผลิตภัณฑ์

Lab Scale

Manufacturing Scale

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Example

41Concept/Feasibility

Design Validation

/ PreclinicalClinical Market approval Post market

Automated peritoneal dialysis (APD)

• เป็นที่ต้องการของตลาด สปสช.มีความต้องการใช้สูง

• เป็นเครื่องมือแพทย์ หลักเกณฑ์ท่ี 11 ประเภทที่ 3

• การขึ้นทะเบียนผลิตภัณฑ์ต้องจัดเตรียมเอกสารในรูปแบบ CSDT

• พัฒนาต้นแบบผลิตภัณฑ์ + ISO 14971

• IEC 60601-2-39• IEC 62304• IEC 60601-1-6• Biocompatibility• Sterile• ISO 13485

• Clinical Evidence• Clinical Evaluation

Repot (MEDDEV 2.7/1 rev 4)

• จดทะเบียนสถานประกอบการผลิตเครื่องมือแพทย์

• จัดเตรียมเอกสารและยื่นค าขอขึ้นทะเบียนผลิตภัณฑ์

• ขออนุญาตโฆษณา• รายงาน AE ให้อย.ทราบ• จัดเก็บประวัติการขาย

สินค้า

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