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.
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:
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.
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).
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.
By following these procedures closely, exporters can ensure safe delivery of their products while also complying with the Malaysian regulations governing exports. This process enables exporters to benefit from the potential offered by Malaysia’s thriving medical device industry without running into any legal problems down the line.
Alongside following the requirements set out by MDA, companies exporting medical supplies from Malaysia must also ensure that their products are safely transported while meeting all international regulations and standards concerning the transportation of healthcare products. This is where medical logistics services DHL Express' Medical Express (WMX) can help.
WMX provides customers with a range of benefits like round-the-clock assistance during the shipment process, insurance coverage up to US$25,000 per shipment and coolant material for temperature-sensitive shipments. Experienced logistics providers will be able to store, transport and deliver temperature-sensitive pharmaceuticals and medical equipment with utmost care and professionalism. Coupled with a specialised medical logistics service, businesses can rest assured that their exported products will arrive at their destination safely and efficiently.