แนวทางการขึ้นทะเบียนและมาตรฐานที่เกี่ยวข้องกับผลิตภัณฑ์เครื่องมือแพทย์ นายธเนศ วิริยะเมธานนท์ วิศวกรชีวการแพทย์ กองควบคุมเครื่องมือแพทย์ สานักงานคณะกรรมการอาหารและยา
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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