Southeast Asia is a rapidly growing trade market, but it can be difficult for companies to enter the region. The global trend of aging populations means the demand for healthcare services will continue to rise, and healthcare spending in Southeast Asia is growing faster than anywhere else.
Medical devices worth five billion dollars were imported into the United States in 2012, and that number has been increasing over time. This article will offer some tips on importing medical devices into Southeast Asia.
1. Register with the Local Regulatory Body
Applying for a quality control certificate issued by a recognized authority is a compulsory requirement before exporting products to any country, and it must be done in advance of shipment from your facility. For medical devices in Southeast Asia, this means going through the Singapore International Medical Device Regulatory Agency (IMDRP).
2. Know What is Obligatory and Voluntary
In addition to the compulsory requirements described above, some countries may have specific rules for importing products from your country of origin. A good example would be importing your device via a balikbayan box from Singapore to the Philippineswhich is a very common method of shipping and is generally not subject to any special rules.
With other rules, this can include import taxes or licensing fees that may be charged by other government agencies, such as Indotrade (Indonesia) or JAPEMEI (Malaysia).
All requirements should be confirmed before any product is shipped to ensure import tax and licensing fees are paid. It’s also a good idea to find out if there are any legal issues associated with your product, such as patent infringement.
3. Register Your Products
Product registration can be done at each country’s regulatory body. It is the first thing that the regulatory body will want to see before approving product release, and it must be done before applying for any certificates. It should also be noted that the names of contact persons should be listed on all product registrations.
4. Prepare Documents
Various documents are required before applying for any certificates, including a commercial invoice, packing list, material safety data sheets (MSDSs), test reports, and certificates of analysis. It is also recommended that you have other supporting documents about your product, such as invoices for raw materials used.
5. Apply Early
Application for certificates should be done at least two weeks before the certification is needed. Remember that applications are not always approved immediately – approval can often take several weeks or months depending on your product and the country it is being exported to.
6. Use a Consultant
Companies and other parties that need to be involved in the application process can make things easier by using a medical device consultant. This expert will guide you through the process, ensure all documentation is accurate, provide fast-track support as required, and liaise with local regulatory bodies on your behalf.
7. Register Your Product with the FDA
In addition to certifying your product for medical use, you will also have to register your device with the US Food and Drug Administration (FDA). Companies can register their products on FDA’s website, and the registration process takes around 30 minutes. It is complete when companies receive an approval letter from the FDA.
8. Print a Certificate of Conformity
Once your product has been approved, you will need to print a certificate of conformity for each device or batch that is intended for export. You can then use this document when shipping the device from your facility to the country where it will be used.
9. Apply for a CE Mark
In addition to registering your products with the FDA, you will also need to apply for a CE mark. This is a conformity assessment standard recognized by all countries in the European Union (EU).
To gain approval, you will have to fill out an application and pay a fee before sending your product for testing at an approved lab. Once it has been tested and approved, you can print a CE mark which should be attached directly to each device or batch.
10. Ensure Your Products Are Marketed Correctly
Many countries in Southeast Asia require that products are marketed correctly and come with complete instructions. For example, in the Philippines, hospitals and pharmacies must only be supplied through authorized distributors or sellers.
If you have not already done so, it is a good idea to check that your product’s packaging and labeling are in line with the country where it will be used. It also helps to include information on how your product should be used in all documentation, such as protocols for use and clinical study holdings.
In short, it is vital to take the time to ensure your product is certified for medical use before shipping it to any destination. You should also make sure you are aware of any legal issues that could affect your products during their distribution in Southeast Asia.
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