Introduction to Medical Device Registration in Malaysia

This article deals with the Medical Device Registration in Malaysia. Malaysia is one of the most robust and dynamic markets for foreign medical device manufacturers as the government is supporting medical tourism. Due to the regulatory changes, the registration of Medical Devices is made compulsory. Submitting documents to prove that the products are compliant with the Malaysian device regulations to obtain approval is required under Malaysia’s new regulatory system. Medical device Registration and Regulations are solely done by the Malaysian Medical Device Authority (MDA).  All foreign Manufacturers need to obtain the (CAB) Conformity Assessment Body Certification, which allows them to get the MDA approval, prior to their submission of the product registration.

Registration of Medical Devices in Malaysia 

To register Medical Devices in Malaysia, the following steps are required to be followed- 

Step 1

All Foreign manufacturers with no local presence must appoint an Authorized Representative/Distributor/Establish their own Subsidiary to hold their license who will handle the registration process of their devices. The AR will act as the foreign manufacturer’s local agent or license holder during the process and after registration approval. The AR also handles mandatory post-market surveillance activities. The AR prepares technical information for the registration of the application as per Common Submission Dossier Template (CSDT) received from foreign manufacturers and submits it to the Malaysian Medical Device Authority (MDA) through the online system.

Step 2

An independent Conformity Assessment Body (CAB), reviews the registration application dossier and then issues a certificate that is submitted to the MDA. Without a CAB certification, the MDA will not approve the product for the registration process. To make the review process simple, the manufacturer should provide evidence of compliances such as  the device being recognized in the USA, EU, Australia, or Canada. 

Step 3

The Following Documents are needed for Registration- 

  1. General Information on the Medical Device
  2. Information on Manufacturer of Medical Device
  3. Grouping of Medical Device
  4. Common Submission Dossier Template (CSDT)
  5. Post-Market Vigilance History
  6. Declaration of Conformity
  7. Attestation for Medical Device Registration
  8. Instructions for use (IFU) and Label 
  9. ISO 13485 Quality certificate.

Step 4

Process of Registration

Product registration process begins once the class of the product is determined and an AR is appointed. The AR will submit the documents as per the CSDT template through the online portal. To register the Medical Devices in Malaysia there is no requirement for  Local testing and clinical studies, but approval from the Country of Origin is required. The timeline for approval is approximately Nine months and the Certificate of Approval is valid for 5 years. 

Importation 

Medical device registration can be applied by local manufacturers and  by AR. An importer can conduct his activities only on obtaining an Establishment License. In Malaysia all medical devices (goods) to be imported, must declare the registration number, description of goods, packages, value, weight, quantity, and country of origin. All duties/custom taxes imposed on imported goods need to be paid in advance by electronic fund transfer before the Customs Office Authorizes the export or the import of a good. To import the goods the applicant should submit a custom entry form, bill of lading/airway bill, Pro-forma invoice, packing list, Certificate of Registration issued by MDA, and other authorized licenses and certificates. Goods originating from ASEAN countries, (ie; China, Japan, Korea, Pakistan, Australia, New Zealand, India, Chile) imported into Malaysia may enjoy preferential rates of duty, under the relevant free trade agreements between the countries.

How can Morulaa Help?

Morulaa HealthTech as a successful regulatory and Import Consultants have delivered High levels of professionalism towards our clients. To understand how the Regulatory Approval Process in Malaysia  and other Southeast Asian Countries is done, contact us to know more. 


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