Frequently Asked Questions - Registration, Licensing & Enforcement
Frequently asked question about Registration, Licensing & Enforcement
Process output for establishment license for 2015 KPI – 21 working days with complete application
Yes, you still can do the placement in Malaysia market and the medical device are responsible by the Authorised Representative
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
Refer to Act 737; Assessment procedure must be carried out by a registered CAB.
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.
COVID Self-test kit can only be sold by registered pharmacies and healthcare facilities.
Retailers must be authorized to sell the registered OTHER medical devices by the distributor, and only home use devices can be sold to the general public through retailers.
Manufacturer can also be distributor of its own medical device. ISO 13485 is sufficient if it is for the medical device it manufactures.
Distribution is an important activity in the integrated supply-chain of medical device. The activities carrying out by the establishment shall be in accordance with GDPMD throughout the supply-chain of medical device. A retailer that warehouses medical devices need to be under the purview of the distributor and the GDPMD of the distributor will require all storage facilities to be audited.
All registered medical device shall comply with labelling requirements as per MDA/GD/0026. The registered medical device shall be labelled with Malaysian medical device