Exporting medical supplies from Malaysia: MDA's procedures

In recent years, the global healthcare market has become increasingly competitive with a growing consumer interest in health products. Countries such as Malaysia can capitalise on this trend by positioning themselves as a major exporter of medical supplies. The Malaysian government has streamlined the export process with the Medical Device Authority (MDA), making it easier for companies to export medical equipment, devices and consumables. 

Let's take a closer look at what you need to know about exporting medical supplies from Malaysia. 

Requirements & procedures for exporting with MDA 

The MDA is responsible for regulating the safety and quality of medical devices in Malaysia prior to their local sale or export overseas. All exporters must register with MDA in order to be able to obtain an Export Permit before they can begin shipping any products abroad. To apply for an Export Permit, exporters must provide information about their intended destination country, product details, and other relevant documents such as Certificate of Free Sale or Quality Assurance Certificates. Once all documents are approved, exporters will be issued an Export Permit which allows them to ship their goods out of the country. 

The details of the export procedure are as follows:

1. The MDA registration process 

The first step in exporting any medical product from Malaysia is registering with the MDA. All manufacturers, importers and local agents for foreign manufacturers must register their devices with MDA in order to export their products abroad. This registration process requires submitting an application form along with supporting documents such as a valid business licence as well as product certification or evidence of quality management systems. Once the registration has been approved, the manufacturer will receive an MDA Registration Number which they can use to complete further steps in the export process. 

2. Quality assurance requirements 

Exporters must comply with all relevant Quality Assurance requirements outlined by the Ministry of Health (MOH) and MDA prior to exporting any medical device. The requirements vary depending on the type of product being exported, but generally, it includes ensuring that all devices have CE Marking or similar international certifications from countries like Australia or Japan that indicate that they meet quality standards set by those countries’ regulatory bodies. Additionally, exporters are responsible for providing instructions of use in both English and Bahasa Melayu (the official language of Malaysia). 

3. Shipping process 

Once the medical devices have been registered and approved by MOH/MDA, exporters must obtain shipping permits for their devices from customs authorities before they can be exported out of Malaysia. This permit serves as proof that all necessary documentation has been provided and that all applicable taxes have been paid on the shipment. After these documents have been secured, exporters can proceed with shipping their products out of Malaysia via air or sea freight depending on their needs. Exporters must take caution that all export licences and special permits are obtained, and global customs law and regulations are adhered to.