In a bid to improve the health sector, most governments and private parties import medical devices. However, it is not a “one call settles it all” kind of scenario. Depending on factors such as the prevailing market, international relations, foreign trade policies, your home country’s GDP, and the current regulations, the entire process can be a bit overwhelming.
All the while, you will also want to ensure you get the best quality of standard medical devices at the best price to make a profit as you sell them to the (established and ready) local market. Nonetheless, you are likely to be in competition with a bunch of other providers, including governmental and non-governmental organizations. With these and other challenges at play, you need to be smart and well informed as an entrepreneur before making a big move. After all, adequate preparation and planning is the best weapon you can have as a businessperson.
To help make it clearer for you, here are some essential details you want to keep in mind before importing medical devices for sale.
1. Regulation
Depending on the country of origin or destination, there are various regulations imposed. The FDA, for instance, is the body tasked to regulate these products in the US. It is responsible for performing pre and post evaluation analyses and tests to find out the effectiveness and safety of such devices.
The set laws and regulations are meant to ensure the safety and quality of devices getting into the country. Failure to adhere to the set guidelines may lead to your products being held by the authorities. This is why it makes sense to check out the relevant medical device regulations (MDR) website in your state or country before placing your order abroad or finalizing your shipment request for the products. This way, you can avoid a plethora of unpleasant scenarios, including getting your shipment held at the port or incurring heavy penalties for importing and selling certain medical products to consumers. You can also stay compliant with other requirements, like the CER literature review and MDR post-market surveillance for some medical devices.
2. Device Registration
Due to increased cases of importation of unlicensed devices, many countries have opted for device registration. The importing parties are supposed to have documents indicating the conformity of the devices to the set standard. The quality standard department checks to ensure that the products are in line with the country’s code and technical aspects. The particulars of this often vary per country.
3. Pre-Market Approval
This ensures that products sold have data showing their safety and efficiency. It is a lengthy process, often nerve-wracking for many manufacturers. A device that has a track record of usefulness is exempted from this process. However, for medical devices used in life support treatment, this step is vital. Having a device go through this process is necessary to avoid lawsuits when there is a negative effect on the patient. Though it is costly, in the long run, it is worth the extra bucks and waiting time.
4. Medical Device Classification
Most medical devices entering the country must be labeled. In the United States, the FDA medical device classes are I, II, and III. The labeling is influenced by the level of risk posed by the device to the patient or intended user. Class I is seen as low risk, while class III medical devices are deemed high risk. Classification determines how much duty is paid for the device. Also, it influences the regulation for the sale of a product. Therefore, before importing, you should go through the classification guide. It will help you know if your device is in line with the regulations set for its intended use. It will also go a long way in shedding some light regarding market clearance and the total costs of the product, as well as your selling price.
5. Device Reporting and Tracking
This is not necessary for all devices. However, for some class II and III devices, there is a need for reporting and tracking. The regulatory body checks for complaints associated with the product. If there is any, access is denied. Tracking is mostly done when a medical device reaches the market. This is to make sure it does not pose any danger to the consumer. In case of proven doubts, the product can be discontinued and withdrawn from the market.
All these rules and guidelines are imposed due to the delicate nature of the medical sector. A mishap or overlooking of a process poses danger to the citizens. Therefore, critical caution is required from suppliers, distributors, and retailers who import and sell medical devices. Everything has to be in order if one is to avoid hefty fines, fees, and losses, some of which can be overly costly to your finance and reputation as a brand.