Frequently Asked Questions - Registration, Licensing & Enforcement
Frequently asked question about Registration, Licensing & Enforcement
Please refer to document:
MDA/GL No. 2 - How to apply for establishment License under medical device act 2012 ( Act 737)
Please refer to document:
MDA/GL/004 - Application For Renewal Of Establishment License
All establishments, ie manufacturer, authorised representative (AR), importer and distributor must apply for establishment licence. However, only manufacturer and AR need to apply for medical device registration.
A distributor is a person or company appointed by an AR (for medical device manufactured in foreign country) or a manufacturer (for locally manufactured medical device) to further medical devices registered by the AR or the manufacturer into the Malaysian market. A distributor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an establishment license to conduct its activity.
There is no issue if the name of the distributor differs with the name of the manufacturer. However, an AR cannot be the brand owner.
Various people or entities who are responsible for procurement, transportation, delivery, storage, device tracking, installation, commissioning, service, maintenance and calibration, need to be appropriately managed and regulated to ensure safety and performance of medical devices at the point of use. The level of risks associated with these activities may be of similar degree as those in the manufacturing environment and the lack of control over these activities may affect safety and performance of the devices. GDPMD specifies the requirements for a quality management system (QMS) to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with medical device regulatory requirements as stipulated in Act 737 and its subsidiary legislations. GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the regulatory requirements throughout the supply-chain. The requirement for GDPMD is stipulated as the QMS requirement for those involved in medical device supply chain, namely the AR, importer and distributor as required para 11 of Third Schedule of MDR2012.
GDPMD is a requirement for establishment licensing of distributor. It is a type of QMS to ensure the safety
and performance throughout the medical device supply chain. The GDPMD will be assessed and certified by
the CAB. The certificate issued by the CAB shall be submitted as part of the requirements for establishment
Only certain non-confidential information on licensed establishments and registered medical devices will be made available for public access. Sections 67, 68 and 69 of Act 737 and Regulations 21 and 22 of MDR2012 give the provisions on how the Authority shall handle the information.
No, as long as they do not involve in any activities related to distribution. Tendering agent are strictly for the purpose of procurement with the government hospital
You may asked for the copy of establishment licensing certificate directly from your manufacturer/ Authorized representative (AR) / distributor. It is a requirement for Ministry of Health procurement division to ascertain that this products are from a licensed establishment and registered. MDA will not provide any letter for tendering agent. If they are still facing a problem, the tendering agent may call directly to MDA.
Requirement for CAB recognition must be from a local CAB in Malaysia that are registered under Section 10, Act 737.
For manufacturer, it is required to have ISO 13485, not GDPMD
Please write an official letter to MDA to notify us on this
Establishment can apply establishment license once they get provisional certificates. Establishment need to update MDA once they get full certificates.
If the distributor is not licensed, then, as AR, you are responsible to not appoint the establishment as your distributor.
If our Singapore office staff is handling everything in Singapore, is this acceptable? Answer If the medical device is place in Malaysia market, then it is subjected to Act in Malaysia. AR must have licensed and domicile in Malaysia
MDA will refer to legal manufacturer only.
Answer MDA will take action to the individual involve, not only the establishment under Malaysian act