Understanding the Medical Device Regulatory Pathway in ASEAN - Package for 6 Countries - Course for Philippines shall be updated in June

Program ID: RP-B-001

Package Geographical Regions: Global

USD 999.00

USD 999.00

This training courses describe the regulatory framework and the general pathway for medical device registration in Singapore, Malaysia, Vietnam, Philippines, Indonesia and Thailand.

The course begins with an overview of the regulatory pathway in respective countries with an emphasis on the current regulations implemented by the authority.

We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to the local regulations and are submitted for approval to the local Authorities. The execution of all work within the main workflow will be covered with details of tasks, assessments, timelines and costs.

The courses will provide you with a good insight into the ASEAN regulatory system and sound knowledge from beginning of registration through the other stages of product life cycle.

Learning Objectives: 

  • Understanding the regulatory framework and general pathway for medical device registration in Singapore.
  • Understanding the regulatory framework and general pathway for medical device registration in Malaysia.
  • Understanding the regulatory framework and general pathway for medical device registration in Vietnam.
  • Understanding the regulatory framework and general pathway for medical device registration in Philippines.
  • Understanding the regulatory framework and general pathway for medical device registration in Indonesia.

Who Should Enroll: 

Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

Full Rebate from Us!

If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Singapore, Malaysia, Vietnam, Philippines and Indonesia the payment for this program will be offset against any future invoices.


This Program Includes:
  1. Understanding Medical Device Regulatory Pathway in Philippines - Course shall be updated in June

    This training course describes the general pathway for regulatory framework and medical device registration in Philippines.
    The course begins with an overview of the regulatory pathway in Philippines with an emphasis on the current system and the impending implementation of the new regulations by the authorities.


    We work through the basics of each step of the licensing and product registration process and explain how medical device dossiers are compiled to conform to Philippine regulations and are submitted manually for approval to the Food and Drug Administration. The execution of all work within the main workflow will be covered with details of tasks, timelines and costs.

    The course will provide you with a good insight into the Philippine regulatory system and sound knowledge of registration.

    Learning Objectives: 

    • Understanding the regulatory framework in Philippines
    • Understanding the general pathway for medical device registration in Philippines

    Who Should Enroll: 

    Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

    Full Rebate from Us!

    If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Philippines, the payment for this program will be offset against any future invoices.

    Click To Buy
  2. Understanding the Medical Device Regulatory Pathway in Indonesia

    This training course describes the regulatory framework and the general pathway for medical device registration in Indonesia.
    The course begins with an overview of the regulatory pathway in Indonesia with an emphasis on the current system and the implementation of new regulations by the authorities.

    We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to Indonesian regulations and are submitted online for approval to the Ministry of Health. The execution of all work within the main workflow will be covered with details of tasks, timelines and costs.

    The course will provide you with a good insight into the Indonesian regulatory system and sound knowledge of registration.

    Learning Objectives: 

    • Understanding the regulatory framework in Indonesia
    • Understanding the general pathway for medical device registration in Indonesia

    Who Should Enroll: 

    Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

    Full Rebate from Us!

    If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Indonesia, the payment for this program will be offset against any future invoices.

    Click To Buy
  3. Understanding the Medical Device Regulatory Pathway in Malaysia

    This training course describes the regulatory framework and the general pathway for medical device registration in Malaysia.
    The course begins with an overview of the regulatory pathway in Malaysia with an emphasis on the current regulations implemented by the authorities.

    We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to Malaysian regulations and are submitted online for approval to the Ministry of Health. The execution of all work within the main workflow will be covered with details of tasks, assessments, timelines and costs.

    The course will provide you with a good insight into the Malaysian regulatory system and sound knowledge of registration.

    Learning Objectives: 

    • Understanding the regulatory framework in Malaysia
    • Understanding the general pathway for medical device registration in Malaysia

    Who Should Enroll: 

    Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

    Full Rebate from Us!

    If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Malaysia, the payment for this program will be offset against any future invoices.

    Click To Buy
  4. Understanding the Medical Device Regulatory Pathway in Singapore

    This training course describes the regulatory framework and the general pathway for medical device registration in Singapore.
    The course begins with an overview of the regulatory pathway in Singapore with an emphasis on the current regulations implemented by the authority.

    We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to Singaporean regulations and are submitted online for approval to the Health Sciences Authority. The execution of all work within the main workflow will be covered with details of tasks, assessments, timelines and costs.

    The course will provide you with a good insight into the Singaporean regulatory system and sound knowledge from beginning of registration through the other stages of product life cycle.

    Learning Objectives: 

    • Understanding the regulatory framework in Singapore.
    • Understanding the general pathway for medical device registration in Singapore

    Who Should Enroll: 

    Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

    Full Rebate from Us!

    If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Singapore, the payment for this program will be offset against any future invoices.

    Click To Buy
  5. Understanding the Medical Device Regulatory Pathway in Thailand

    This training course describes the regulatory framework and the general pathway for medical device registration in Thailand.
    The course begins with an overview of the regulatory pathway in Thailand with an emphasis on the current system and the implementation of new regulations by the authorities.

    We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to Thailand Food and Drug Administration (Thai FDA) regulations and are submitted online for approval to the Thai FDA system. The execution of all work within the main workflow will be covered with details of tasks, timelines and costs.

    The course will provide you with a good insight into the Thai regulatory system and sound knowledge of registration.

    Learning Objectives: 

    • Understanding the regulatory framework in Thailand
    • Understanding the general pathway for medical device registration in Thailand

    Who Should Enroll: 

    Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

    Full Rebate from Us!

    If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Thailand, the payment for this program will be offset against any future invoices.

    Click To Buy
  6. Understanding the Medical Device Regulatory Pathway in Vietnam

    This training course describes the regulatory framework and the general pathway for medical device registration in Vietnam.
    The course begins with an overview of the regulatory pathway in Vietnam with an emphasis on the current system and the implementation of new regulations by the authorities.

    We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to Vietnamese regulations and are submitted online for approval to the Ministry of Health. The execution of all work within the main workflow will be covered with details of tasks, timelines and costs.

    The course will provide you with a good insight into the Vietnamese regulatory system and sound knowledge of registration.

    Learning Objectives: 

    • Understanding the regulatory framework in Vietnam
    • Understanding the general pathway for medical device registration in Vietnam

    Who Should Enroll: 

    Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

    Full Rebate from Us!

    If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Vietnam, the payment for this program will be offset against any future invoices.

    Click To Buy

Dr Claire Lacey 

Dr Claire Lacey is a Service Line Director at Andaman Medical. She was born and educated in the UK and gained her BSc. (HONS) in Biochemistry and DPhil. in Organic Chemistry at the University of Sussex. Upon completion of her postdoctoral studies as a Research Fellow at University College London, Claire gained global experience as a Medicinal Chemist within the area of early drug design and discovery. Her career spanned both the large pharma and biotech sectors, working in the UK, North Carolina and California in the USA and Singapore. Currently, Claire is applying her skills in organisation and communication within the Medical Device Registration and Representation Industry, where at Andaman Medical she is focussed on project management and global client communication.


 
Duddao Chaidee 

Duddao Chaidee is a regulatory consultant in Andaman Medical (Thailand) Co., Ltd. with a thorough specialized knowledge of regulations and product registration of medical devices in Thailand.

She holds MSc in Biomedical from Srinakharinwirot University – Bangkok Thailand. Nina has been working in medical devices sector including IVD company as a Regulatory Affairs Specialist for over 7 years. Her experience covers medical device product registration in ASEAN, cosmetics and foods product registration in Thailand.


 
Femilia Aulina 

Femilia Aulina has been working in the Medical Device sector for more than 5 years as a Regulatory Affairs. She is a regulatory consultant in PT Andaman Medical Indonesia with a thorough specialized knowledge of regulations and product registration of medical devices in Indonesia.

She holds a degree in Bachelor of Science and Apothecary.


 
Jhelum Bandyopadhyay 

Jhelum is a regulatory consultant in Andaman Medical Pte. Ltd. with a thorough specialized knowledge of regulations and product registration of medical devices in Singapore.

She holds a specialized degree in Medical Device Regulatory Affairs from National University of Singapore and RAPS Online University along with her Biotechnology and MBA degree. Jhelum has comprehensive experience in technical data interpretation and good knowledge of medical devices industry,  as well as post-market surveillances.


 
Melody Quebec 

Melody Quebec is a regulatory consultant in Andaman Medical Philippines Corporation with thorough knowledge of Medical Device regulations, specialized in licensing & product registrations for medical devices in Philppines.

Melody Quebec is a graduate of Bachelor of Science in Pharmacy. She is a licensed pharmacist in the Philippines with 14 years of regulatory compliance experience in Food, Cosmetics, Medical Devices and Drugs where scientific, technological or professional knowledge of pharmacy is applied. Likewise, she is also experienced in dealing with other Philippine government regulatory agencies such as SRA, SEC, IPO, PDEA-DDB, DENR & NTC.


 
Tan Shouzheng 

Shouzheng is a regulatory consultant in Andaman Medical Bridge Sdn. Bhd. with a thorough specialized knowledge of regulations and product registration of medical devices in Malaysia.

He holds a Bioprocess Engineering degree from University Malaysia Perlis (UniMAP). Shouzheng has comprehensive experience in clinical data evaluation, technical data interpretation and good knowledge of medical devices industry,  as well as post-market surveillances.


 

Program Highlights
Duration: 6 hrs
Released On: 02/06/2020
Downloadable Resources: 
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