Being an internationally approved regulatory device can be one of the most challenging things you might undertake. It’s worth it in the end to have your device approved in multiple countries.  It’s best to contact three or more countries with different regulatory bodies. An online search will provide you with lists of country regulatory bodies. Your device must meet international standards and regulations before being considered commercially available anywhere in the world. But before your device can be sold in any country, you must have regulatory approval in at least one country. Then you can begin to write a dossier and have that dossier accepted by a regulatory body. Here are some tips on how to get that international approval.

1. Define the Product

Know what you are creating and make sure it has medical value.  Medical value means it will help people with certain medical conditions. Even if your device is simple, you must ensure your machine will help the physicians’ patients. If your device has no value, the approval process may not interest the regulatory body. Since regulations applicable to medical devices are created by governmental bodies, the regulatory body will evaluate your device based on its medical value.  You need to prove that your device has a medical benefit and does not cause harm.

2. Identify the Relevant Regulatory Requirements

You’ll need to get a list of all applicable regulations from the country you intend to apply for international approval. The regulatory body should be informed about all the rules that need to be met and would like it if you had obtained certification in a regulatory body before applying. Make sure each requirement is followed correctly and correctly filled out.  Otherwise, your application will be rejected, and your time will be wasted.  If your product is appealing enough, they will allow you extra time if needed. They provide documentation on their company’s quality management system (QMS) and will inform you of any issues regarding the non-conformity of your product.

3. Establish a Test Plan

Your test plan is the key to any certification process. Since regulatory bodies request devices tested to meet international standards, you need to follow these standards. The test plan is the basis of a successful application. If no problems exist during testing, your device will likely be approved and sold internationally. The regulatory body won’t find value in supporting your device without a proper test plan.  You must ensure the regulatory body approves your plan before moving forward with your project.

4. Review and Evaluate Your Risk Management File

A risk management plan for your project is essential to new product development; therefore, you must include this in your dossier.  The regulatory body will be sure to check it.  It would help if you addressed risks, the severity of those risks, and ways to minimize them.  If the chances aren’t there or handled properly, making an international application can be difficult because it’s up to the regulatory body’s discretion if they want your application approved or not. Provides a practical framework for the project’s risk management, and other critical documents that the relevant regulatory body will request will also have to be submitted.

5. Verify RoHS Compliance

Medical device compliance software regulations mean the policies and standards adopted by the healthcare market regulation authorities. Medical device regulations have been implemented per the European Union’s requirements (RoHS) chemicals directive.  Companies must strictly adhere to this regulation, or they will be penalized. RoHS is designed primarily to address the increasing concern about the toxicity of materials and chemicals used in electronic device manufacturing.  RoHS regulations are meant to reduce waste, improve production efficiency and decrease costs while ensuring safety.

6. Assemble Representative Samples and Accessories for Testing

When it comes to international requirements, test samples are necessary. You need to provide a sample that meets the regulatory body’s acceptance criteria. You don’t want to leave your final product in foreign hands without a supporting piece of the device for testing. You must ensure your device is correctly assembled according to international regulations and standards.  You can ask the regulatory body for an opinion on the sample if you want to apply for approval in other countries.

7. Prepare the Required Documentation

You will come across numerous documents in the application process. The regulatory body will ask for all the documentation needed to make an application.  Detailed information on your device and your company needs to be included.  Information regarding quality management, design, production, packing, and storage of your device should be provided. Companies need to show that they know all the applicable laws in the country where they want to market their devices. The regulatory body may ask you for more information on how your product was made. You’ll be able to provide them with a detailed list of all materials used in the manufacturing process.

8. Submit the Device for Testing

Medical device testing can encompass various steps, each of which needs to be carefully planned.  The regulatory body will make sure that you do everything correctly. They’ll ask for all the necessary documents, test part information, and samples of your product. The company can follow up on their application later after the process has been completed with all required tests conducted.  

9. Obtain Product Certifications Under Relevant Standards

Once the approval process is complete, you can expect your product to be distributed to other countries.  The regulatory body will take a long time to release your approval, and it’s not uncommon for them to reject your device.  If there are any delays, you may have to pay heavily as a penalty or delay all further deliveries. If the regulatory body rejects your application, they’ll provide you with feedback and will ask if any changes should be made in the future.

10. Obtain Regulatory Approval as Well for Marketing

Once the regulatory body has approved your product, you need to apply for registration with the appropriate bodies in your country.  The regulatory body will provide you with information on how to obtain marketing approval. If you want to market your device in other countries, then it may be necessary for you to file international registrations and also file a materials declaration.  When exporting, one of the things that you can be very careful about is compliance with applicable standards and regulations in other countries.

Conclusion

The Medtech industry has been developing over the past years, and today, it is worth more than $300 billion.  It has become one of the fastest-growing markets in the world.  To be successful, you must go through all the necessary steps before releasing your product into other markets and getting approval from other regulatory bodies. You’ll be able to save a lot of time and money by doing it properly from the start of your project.