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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.

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

license application.

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.

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

Answer MDA will take action to the individual involve, not only the establishment under Malaysian act

Process output for establishment license for 2015 KPI – 21 working days with complete application

AR license can be used to represent many different manufacturer and many products; However, only one (1) product must be represent by one (1) AR

Have to write to MDA and application will be open for changes. In future we will come out with system that will allow changes notification can be done anytime. Currently, write to us and MDA will facilitate for additional necessary changes. If changes of certificate, the latest certificate must be submitted to MDA. E.g. changes of manufacturing sites for GDPMD/ISO 13485, certificate must be submitted to MDA together with the application for amendment.  

The system is still on-going process of upgrading. So, it will be listed on the website once the system is ready.

Contract manufacturer only doing manufacturing for other brand owner but didn’t own the brand. Criteria for manufacturer: Brand owner; and Do manufacturing activities themselves or outsource to OEM

AELB licensed for Act 304 and for MDA, Act 737. For radiation apparatus such as x-ray, it is consider as medical device. Thus, the company need to have a licensed and registered the medical device under MDA.

It can be treated as one and it can be combine in the certification of ISO 13485- during certification process CAB have to access all the plants and covered under 1 certificate

Need to have the establishment license. To comply with the requirement you have to get the GDPMD certificate. As a distributor, you need a letter of authorization from the AR or Manufacturer. U also have to keep the distribution record and you will be the first point of complaint and after that you have to pass it to the AR. AR can have many distributor around Malaysia. As a distributor no need to apply product registration. MDA will know what types of product that distributor sell under AR.

AR, distributor and importer must be certified on GDPMD

The different between retailer and distributor, the AR must appoint you as the distributor whereas for retailer like a pharmacy outlet didn’t need the authorization from AR. Distributor need authorization letter and have a lot of stock. The concept we have in our law is the manufacture can appoint distributor. Whoever appointed, it is a distributor and after distributor is no more. Once distributor distribute to other company that is not distributor

A part of distributor responsibilities, it must make sure that reseller/retailer is operating with the requirement of the law. For example, they can ask you to certify for GDPMD but not a purpose of obtaining the licence. Distributor must make sure that product safe until it reach to consumer. If anything wrong to the product, the distributor will take the responsibilities. If distributor cannot control the reseller, then the reseller can obtain GDPMD because they will be audited and to ensure the product in a good condition.

The product already sold to the user, so the user keeps their stock in the central store; there are not distributor responsibilities anymore. The second level and third level are not covered by the Law.

Definitely one brand for one AR, in future the system will able to know it and alert MDA. At these moment, custom department will know, you have to show a letter to prove that you an AR. We will give a licence and list of products. If you cannot show a letter, custom will hold your goods. If somebody else break the law, they declare that goods not a medical device, you should inform us, then our enforcement will come

You need to tell us if affect your GDPMD certificate or not, for example previously you are distributing condom, catheter and glove. Suddenly IVD reagent, the requirement for IVD reagent storage and glove will be different so you need to tell us the new GDPMD cover the new product. You have to get confirmation from CAB. CAB will give you report and you need to submit a letter to MDA. Then we will put it in the system your new role.

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my