Regulation of Medical Devices
in South-East Asian Nations
Department of Drug Regulatory Affair
College Of Pharmacy
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OUTLINE OF THE PRESENTATION: –
1. Introduction
2. Classification Of Medical Devices And IVD’s With Examples
3. Common steps for medical device registration process in ASEAN
4. ASEAN Medical Devices Directive (AMDD)
5. Structure of AMDD
6. ASEAN Medical Device Regulation Comparison Table
7. Common Submission Dossier Template (CSDT)
8. New in line Regulations for the ASEAN Medical Device in 2022
9. References
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INTRODUCTION
What is ASEAN?
• Association of Southeast Asian Nations
• A political and economic union of 10 member states in Southeast Asia and was established
on 8 August 1967 in Bangkok, Thailand, with the signing of the ASEAN Declaration (Bangkok
Declaration).
• The member nations are working to create harmonized standards in order to remove technical
barriers to trade and support the establishment of an integrated market.
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Conti..
Medical Devices regulation in South East Asian Countries
• The advancement of the healthcare market with harmonized standards is one of the most
important goals of ASEAN.
• Medical devices Product Working Group ( MDPWG) was founded in 2004. The aim of MDPWG
was to implement specific measures to facilitate the integration of the medical device sector.
• The MDPWG came up with the ASEAN Medical Devices Directive (AMDD) , which is based on
the European Medical Devices Directive ( EMDD) and the guidelines of the GHTF.
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CLASSIFICATION OF MEDICAL DEVICES AND IVD’S WITH EXAMPLES
Medical Devices IVD Medical Devices
Class Risk level Device example Risk level Device examples
A Low risk Surgical retractors, Low individual risk and Clinical chemistry
tongue depressors low public health risk analyzer, prepared
selective culture media
B Low-moderate risk Hypodermic needles, Moderate individual risk Pregnancy self testing
suction equipment and /or low public ,urine test stripes
health risk
C Moderate-high risk Lung ventilator, bone High individual risk and Blood glucose self
fixation plate /or moderate public testing, HLA typing
health risk
D High risk Heart valve, implantable High individual risk and HIV blood donor
defibrillator high public health risk screening, HIV blood
diagnostic
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COMMON STEPS FOR MEDICAL DEVICE REGISTRATION PROCESS IN ASEAN
Class A Medical
Devices does not
need registration
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ASEAN Medical Devices Directive (AMDD)
In 2015, the Association of Southeast Asian Nations (ASEAN) signed an agreement, formally called
the ASEAN Medical Device Directive (AMDD), that aimed to harmonize medical device regulations.
What are the Requirements Under AMDD?
• In Annexure 1 of AMDD Essential Principles of Safety and Performance of Medical Devices
is given. A Declaration of Conformity (DoC) stating compliance with the EPSP and also listing its
device name, applicable standards, location of test results, manufacturer information and
responsible person is required.
• Classification of devices is done according to the rules specified in Annex 3.
• A Common Submission Dossier Template (CSDT) is needed for product approval including
samples of labeling, packaging materials and full instructions.
• Post-marketing alert system for identification of unsafe and defective devices and adverse events
reports is required.
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STRUCTURE OF AMDD
How is the AMDD structured?
The ASEAN Medical Device Directive (AMDD) has 24 Articles and 8 Annexes. Out of the 24 articles,
last 6 articles are related to the legalities of the Directive and are not related to the device.
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ASEAN MEDICAL DEVICE REGULATION COMPAIRISION TABLE:
SINGAPORE MALAYSIA INDONESIA PHILIPPINES VIETNAM THILAND
1. AMDD Fully Fully Fully New Regulation New Regulation CSDT format for
Compliance (Phase 1) following AMDD Class II (MD to be
commencement will be notified) and
on March 13, 2020 implemented in Class I (MD be
2022 licensed)& PMAS
2. Regulator Health Medical Ministry of Philippines Food Ministry of Thai Food and
Sciences Device Health and and Drug Health (MOH) Drug
Authority Authority Drug (MoH) Administration Administration
(HAS) (MDA) (PFDA) (TFDA)
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SINGAPORE MALAYSIA INDONESIA PHILIPPINES VIETNAM THILAND
3. Laws No. S Act 737 MOH AO 2018:002 Decree No. Medical Device
334Regulation/ Medical Device Regulation No. Circular 2020- 36/2016/ND- Act 2008 &
2016 Health Act 2012 62 year 2017 001 CP & Decree 2019
products (Marketing No. 169/2018
(Medical authorization
Devices) License
regulation Manufacturer)
4. Review by GDPMD/ISO ISO NA NA NA NA
conformity 13485 13485/GDPMD
Assessment First stage of
Body (CAB) PR
5. Who shall Local registrant Authorized Local importer Importer Local AR or Importer
do the Representative Distributor
registration (AR)
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SINGAPORE MALAYSIA INDONESIA PHILIPPINES VIETNAM THILAND
6.Classification A, B, C, D A, B, C, D A, B, C, D A, B, C, D A, B, C, D I,II,III,IV
7. Validity of Annual 5 years 2-5 years CMDN (Class Class A: Class I, II: 5
Certificate Retention According LOA A): Permanent Permanent years
CMDR (Class B, Class B, C, D: 5 Class III:
C, D) : 5 years years according to
FSC
8. QMS ISO 13485 ISO 13485 ISO 13485 ISO 13485 Or ISO 13485 ISO 13485 Or
Requirements local GMP local GMP
equivalent equivalent
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Common Submission Dossier Template (CSDT)
ASEAN Common Submission Dossier Template (CSDT) is a common template for medical device
manufacturers intending to venture into the ASEAN markets.
• This template is the ASEAN counter part of International Medical Device Regulatory Forum’s
(IMDRF) Summary Technical Documentation (STED)
• The CSDT template is applicable to general medical devices and Class B, Class C & Class D In-
Vitro Diagnostic medical devices.
• AMDD requires the CSDT technical documentation to be presented in English unless the ASEAN
Member State (AMS) require it in any other language.
Key elements of a device CSDT technical file
•Executive summary
•Essential principles and methods used to demonstrate conformity
•Device description
•Summary of design verification and validation
•Preclinical and clinical data (if necessary)
•Device labeling
•Risk analysis
•Manufacturer information – shall include details of manufacturing information, QA measures, and
sterilization methods
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NEW IN LINE REGULATIONS FOR THE ASEAN MEDICAL DEVICE IN 2022
2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies.
Which were supposed to be implemented in 2022, stakeholders need to be well-equipped to face
them and prepare a contingency plan to adopt them for the medical devices already in the market.
MALAYSIA
1. Medical Devices (Establishment Duties and Obligations) Regulations 2019
• From July 1, 2022, this regulation was meant to be effectively enforced by MDA.
• Focus is on: – local medical device establishments’ responsibilities in conducting post-
market (eg. Supply chain) activities.
• Guidance document that to be referred: –
i. Distribution records
ii. Complaint handling record
iii. Mandatory problem reporting
iv. Field Corrective Action (FCA)
v. Medical Device Recall
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CONTI…
2. Medical Devices (Advertising) Regulations 2019
• All forms of advertisement used for registered MD in Malaysia must now comply with the
conditions set out in Section 44 of the Medical Devices Act (Act 737) and the Medical Devices
(Advertising) Regulations 2019.
• To advertise registered medical devices: –
➢ Manufacturers are required to receive written approval from MDA, upon submitting a paid
application (Distributing unregistered advertisement materials is an offense)
• MDA has also published the following guidance documents:
i. MDA/GD/0032: Code of Advertisement (COA) – explains the advertising code that must
be followed when advertising a registered medical device.
ii. MDA/GL/04: Guideline Application for Medical Device Advertisement Approval –
Requirements, which explains how to apply for approval of medical device advertisements.
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CONTI…
INDONESIA
1. Devices that are no longer defined as medical devices
• These kind of medical devices do not require a MA license, prior to circulating the products in Indonesia.
i. Vaccine and pharmaceutical (medical) storage /refrigerator
ii. Oxygen Cylinders that do not have thermally insulated containers
2. Halal Certification in Indonesia
• The Ministry of Religion is gradually developing a halal policy for products and medical devices containing
animal derivatives.
• This policy itself started on 17 October 2021, but the due date of full enforcement for medical devices
varies according to the risk classification as follows:
Class A: 17Oct’26 Class c: 17 Oct’34
Class B: 17 Oct’29 Class D: To be determined
• In addition to this, the Ministry of Religion has also described 17 categories of medical devices that
must be certified halal, as stipulated in “Decree of the Minister of Religion Number 748 of 2021”
concerning Types of Mandatory Products Halal Certified.
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CONTI…
3. Updates on the regulation concerning registration of medical devices in Indonesia.
• To improve the ease of licensing process, the MOH has simplified the registration route for certain
class A medical devices that have the following criteria:
i. Home-Use,
ii. Non-Sterile, and
iii. Non-IVD
• NOTE: MOH is still in the improvement stage and has yet to announce the date of implementation.
4. Post Market Activities Guidance for medical device in Indonesia
• In March 2021, the MOH had issued guidelines for handling post-market activities of medical devices
in Indonesia and also launch the online reporting system called e-watch.
• Following are the related articles and guidance’s:
i. Procedures for Withdrawal and Destruction of Non-Conforming Medical Device
ii. Medical Device Adverse Event Reporting and Procedure
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CONTI…
SINGAPORE
• Singapore’s Health Sciences Authority (HSA) is the first southeast Asian regulatory agency to
introduce and fully implement the Unique Device Identification (UDI) system, to improve
medical device safety and traceability in the country.
• Singapore market registrants selling Class B, C, and D devices may begin submitting UDI
Device Identifier (UDI-DI) data into HSA’s Medical Device Information and Communication
System (MEDICS) online submission system on August 31, 2021.
• The HSA has set up a phased implementation schedule for UDI compliance based on device
type and risk classification:
November 1, 2022 for coronary stents, orthopedic joint replacement implants,
and intraocular lenses
November 1, 2024 for all Class D (high-risk) general medical devices and in-
vitro diagnostic (IVD) products
November 1, 2026 for all Class C general medical devices and IVDs
November 1, 2028 for all Class B general medical devices and IVDs
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CONTI…
THAILAND
• The Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4
in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be
exempted from the Specialist Review requirement in Thailand.
• Intends of Program:
– Reduction of review time to 60 days.
– saving Review fee of manufacturers i.e $1,700 (53,000 Baht).
– Leverages device conformity assessments performed by the Singapore HSA for expedited
registration in Thailand.
– Shortens market entry timeline for their class 4 medical devices in Thailand.
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CONTI…
VIETNAM
1. Risk classification of medical devices will be determined by the license holder.
2. Class A and B will apply for a Declaration of Applicable Standard, while classes C and D submit
applications for a Certificate of MD Registration.
3. Registration Number (Declaration of Applicable Standard or Certificate of MD registration) is
permanently valid.
4. Class A/B application is reviewed by the Department of Health in approximately 10 business days
while Class C/D application is reviewed by the Minister of Health in approximately 40 days.
5. Quick issue for class C/D application is reviewed in approximately 10 business days. Two cases
that can apply for quick issue are:
a. MD that has been granted 1 CFS from reference countries including US, Canada, Japan,
Australia, EU countries, England, Switzerland, China, and Korea.
b. MD that has been granted an Import Permit (IP).
6. No CSDT format is required to be submitted until January 1st of 2023.
(NOTE: Some of these regulations are implemented while others are waited to be enforced)
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CONTI…
PHILIPPINES
• Medical device regulations are set to change greatly in 2022 for PFDA.
• After the first quarter of the year, there will no longer be direct importation or exemption to
registration/notification of medical devices prior to marketing in the country.
• Importers and distributors are now required to disclose their financial relationship with
medical establishments and medical practitioners twice a year.
• Interested parties and affected entities must also watch out for the effectiveness and start of
the transition period to the regulation of medical device retailers.
• Changes to the COVID-19 related regulations are also expected depending on the supplies
and products needed to combat the pandemic.
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Thank You!
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