Regulatory Support

Device Registration

Section 5(1) of the Malaysian Medical Device Act 2012 (ACT 737) requires a medical device to be registered with the Medical Device Authority (MDA) before it can be imported, exported, or place on the market.

The manufacturer or authorized representative (of a foreign manufacturer) shall be responsible for registering a medical device through the web-based Medical Device Centerized Online Application System (MeDc@st)

We provide Medical Device Registration on behalf of the manufacturer or authorized representative.

Post Market Support

Section 40 of the Malaysian Medical Device Act 2012 (ACT 737) and Regulation 5 of the Medical Device (Duties & Obligation of Establishments) Regulations 2019 requires an establishment to submit a mandatory problem report to the Medical Device Authority (MDA) when incident relating to the medical device occurred, carry out an investigation to determine the root cause of the incident, and carry out corrective and preventive actions to eliminate or reduce the risk of recurrence.

We provide regulatory support in mandatory problem reporting and field corrective action.

Program No.	1000197062
Course Title	NPRA's Cosmetic GMP Guideline
Course Objectives	Cosmetic Products in Malaysia are regulated under the Control of Drugs & Cosmetic Regulations 1994. All cosmetic products must be manufactured in accordance with the Guideline for Cosmetic GMP or its equivalent. This program aims to provide participants with an overview of the regulatory control of cosmetic products in Malaysia and an understanding of the NPRA’s GMP Guideline.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Key Staffs, Supervisors, Internal Auditors.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.
Course Title
Course Objectives
Training Hours
Target Group
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000168606
Course Title	Good Distribution Practice for Medical Devices (GDPMD)
Course Objectives	The GDPMD specifies the Good Distribution Practice for Establishments placing medical device on the Malaysian market. This course is designed to provide participants with the practical knowledge to ensure the safety and performance of the medical device at point of use. By the end of this course, participants will understand, apply and comply with the GDPMD.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in GDPMD.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000168607
Course Title	ISO 9001:2015 Internal Audit
Course Objectives	This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct audit through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the QMS for conformance to the ISO 9001:2015 and applicable regulatory requirements.
Training Hours	14 Hours (2 Days)
Target Group	Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000166932
Course Title	ISO 9001:2015 QMS Requirements
Course Objectives	The ISO 9001:2015 requirements are generic and intended to be applicable to any organization, regardless of its type, size, products and services offer. This course is designed to provide participants with the practical knowledge to understand the requirements. By the end of this course, participants will understand, apply and comply with the ISO 9001:2015 requirements.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is in implementation of ISO 9001:2015.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Establishment License

Device Registration

Post Market Support

Second-Party Audit

Program No.	1000184201
Course Title	MDSAP - Internal Audit
Course Objectives	This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct internal audit (MDSAP Model) through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the medical devices QMS and applicable regulatory requirements in accordance to the Medical Device Single Audit Program (MDSAP).
Training Hours	14 Hours (2 Days)
Target Group	Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000155045
Course Title	ISO 13485:2016 Internal Audit
Course Objectives	This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct audit through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the medical devices QMS for conformance to the ISO 13485:2016 and applicable regulatory requirements.
Training Hours	14 Hours (2 Days)
Target Group	Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000169149
Course Title	Understanding the Requirements of MDSAP (Medical Devices Single Audit Program)
Course Objectives	This course is designed to provide participants with the practical knowledge to understand the MDSAP requirements. By the end of this course, participants will be able to understand the MDSAP requirements, the Audit Model & Sequence and the details Audit Tasks (for the primary MDSAP processes and the supporting processes).
Training Hours	14 Hours (2 Days)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Medical Devices Single Audit Program.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000156854
Course Title	CE Marking of Class I Medical Devices - EU MDR 2017/745
Course Objectives	This course is designed to provide participants with the practical knowledge to comply with the Regulation (EU) 2017/745 on Medical Devices. By the end of this course, participants will: Understand the obligations of manufacturer, authorized representative, importer and distributor for placing a Class I medical device on the EU market. Aware of the conformity assessment procedure, general safety and performance requirements, requirements of technical documentation, clinical data, post market surveillance, vigilance and market surveillance.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in CE Marking of medical devices.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000169145
Course Title	Fundamental & Practices of Process Validation
Course Objectives	This course is designed to provide participants a systematic approach and the practical knowledge to carry process validation. By the end of this course, participants will be able to: Understand the fundamental of process validation. Conduct process validation.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in validation of production process.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000184100
Course Title	ISO 14971:2019 Risk Management
Course Objectives	This course is designed to provide participants with the practical knowledge and skills to identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls are in placed. By the end of this course, participants will be able to manage risks associated with the medical device in accordance to ISO 14971:2019.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in risk management of medical devices.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000168654
Course Title	ISO 9001:2015 Risk-based Thinking
Course Objectives	The ISO 9001:2015 require companies to continual align the QMS with the Strategic Direction and Organization Context in order for the company’s QMS remain relevant. This course is designed to provide participants with the practical knowledge to apply risk management process in the context of ISO 9001:2015. By the end of this course, participants will be able to manage the risks & opportunities within the scope of the QMS and organizational context in a systematic manner.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in risk management of ISO 9001:2015.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000185439
Course Title	ISO 13485:2016 QMS Requirements
Course Objectives	This course is designed to provide participants with the awareness of the ISO 13485:2016 throughout the product life cycle of a medical device, with emphasize on the applicable regulatory requirements. Having completed this course, participants will gain the knowledge of ISO 13485:2016 and aware of the applicable regulatory requirements of a medical device.
Training Hours	7 Hours (1 Day)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is responsible implementation of the medical devices QMS.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000155042
Course Title	Understanding the Requirements of ISO 13485:2016
Course Objectives	This course is designed to provide participants with the practical knowledge to interpret and apply the ISO 13485 requirements throughout the product life cycle of a medical device and comply with the applicable regulatory requirements. By the end of this course, participants will: Understand the requirements of ISO 13485:2016. Interface of the ISO 13485:2016 with applicable regulatory requirements throughout the product life cycle of a medical device.
Training Hours	14 Hours (2 Days)
Target Group	Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is responsible implementation of the medical devices QMS.
Primary Language	English
Secondary Language	Bahasa and Mandarin

Program No.	1000196863
Course Title	Cosmetic GMP Internal Auditor
Course Objectives	This course is designed to provide participants with the practical knowledge and audit skills to conduct audit on NPRA's or ISO 22716 Cosmetic GMP Guideline. By the end of this course, participants will be competent to conduct internal audit on the QMS for conformance to the NPRA’s or ISO 22716 Cosmetic GMP Guideline.
Training Hours	7 Hours (1 Day)
Target Group	Internal Auditors, Responsible Person, Managers, Key Staffs, Supervisors.
Primary Language	English
Secondary Language	Bahasa and Mandarin