Medical device importation
Only registered medical devices may be imported into the 6 major ASEAN countries we cover, unless the product has been exempted from registration. Each country has its own country-specific regulations, requirements and procedures not only for registration but also for the importation of medical devices and IVDs, it is therefore advisable to work with a local partner on-the-ground in your target country to ensure a successful market access strategy.
What are the typical requirements for importing medical devices?
- Typically, an importer’s license or equivalent will be required in order to import medical devices
- In general, only locally registered companies will be able to apply for an importer’s license, which means that foreign manufacturers either have to establish their own subsidiary office OR appoint a Local Authorized Representative (LAR) who can import directly themselves or who will work alongside nominated importers concerning regulatory aspects
- Some countries require importers to have Good Distribution Practice for Medical Devices (GDPMD) certification
- Depending on the country, a Letter of Authorization for Importers may be necessary either from the manufacturer or the LAR.
Are there any exemptions?
- Most countries allow for certain products to be imported using Special Access Routes such has been witnessed with emergency access and expedited registration for COVID-19 related pandemic products
- Exemptions may also exist for products that are in transit (i.e., imported for export) to bypass the need for registration locally and therefore avoid the need to obtain an import license, however this option does not exist in each country
- Exemptions typically apply for exhibitions, training or research purposes.
Importers duties and obligations
Most countries impose mandatory duties and obligations on importers of medical devices and IVDs such as:
- maintaining a Quality Management System such as GDPMD certification
- facilitating customs clearance and goods delivery.
- maintaining a record of all imports (and exports)
- maintaining records of any complaints
- reporting any adverse effects or field safety corrective actions to the relevant local medical device authority.
How Andaman Medical can help with importing medical devices:
Depending on your target country, we will act as your appointed importer as well as your independent local authorized representative or marketing authorization holder. This means you can retain the freedom to appoint as many distributors for your device as you require, while your product license remains unaffected by any changes in your distributor network.
