International Medical Device Authorizations: 5 Steps to New Markets

The authorization process often drags on as a result of simple communication difficulties. The reasons for this are complex and range from language barriers, to different understandings of requirements, through to cultural customs.

Finding concrete and correct requirements is also always a hurdle. Regardless of whether it is provided by local distribution partners involved in the authorization or by authorities, the information is often incomplete or only provided bit by bit.

In addition, terms can be defined in different ways, which can lead to misunderstandings. And everyone who has ever gone through an authorization process knows the challenges of bureaucratic structures.

Some even get the feeling that the authorities act arbitrarily if the documentation the manufacturer has gone to great effort to create to the best of their knowledge still does not meet the requirements in the end.

In the survey, a lot of manufacturers also classified their own lack of knowledge as an obstacle. They also frequently mentioned the fact that there are different requirements in different countries as a difficulty.

Conclusion: Going through the international authorization process can be expensive, time-consuming and frustrating.

Step 1: Project planning

Every project starts with an objective. This should include:

• Selecting the markets
• Selecting the devices
• Time and sequence of market entry

Identify the authorities that regulate the authorization of your medical device in the country in question. The website of the corresponding authority won’t just contain (most of) the authorization requirements, it will also contain initial information on the process and the costs.

If possible, determine the classification of your device and the corresponding authorization pathway. These aspects usually have an impact on duration and costs.

These costs include the internal costs and regulatory fees and, if applicable, the ongoing costs of maintaining the authorizations. Maintaining an authorization often costs several thousand euros per year.

If you are missing information (e.g., because it is not available in English) that you need to complete the initial project planning, use:

• A local authorized representative who can communication with authorities locally
• An authorization partner who will be responsible for the registration
• A consultancy company that specializes in international authorizations
• The competent authority Particularly in the case of devices that use novel technologies, consulting with the authorities early to agree on the authorization process can be advantageous.

The checklist (linked to below) will help you ensure that you have all the relevant information for planning the project and, therefore, the duration, costs, and time and effort.

Step 2: Selecting an authorization partner

A local authorization partner is mandatory in a lot of countries. This person must, for example, carry out the registration and authorization, and communicate with the authorities as an authorized representative.

Advantages and disadvantages

Each type of authorization partner has advantages and disadvantages:

Table 1: Advantages and disadvantages of different types of authorization partners

Decision criteria

Before deciding which authorization partner is best for you, ask yourself the following questions:

• How much time and effort does changing authorization partner require? Is it even possible?
• Is having several distributors for one device permitted?
• Who is allowed to appoint more distribution partners?
• Is it possible to have a device authorized through several partners?

If you already have a partner you want to use, check whether they meet the necessary requirements for the authorization of the device. Important requirements are:

• Existence of a quality management system
• Expertise
• Regulatory approvals
• Reliability (if necessary, request references)

Content of the contract

The contract with your authorization partner should:

• Ensure you get full access to the authorization documentation.
• Ensure you get access to the certificate or a copy of the certificate.
• Cover market surveillance obligations and how customer feedback is handled
• Cover initial and ongoing costs for the authorization, communication with the authorities, feedback, etc.

Step 3: Defining the regulatory framework

You now need to establish the detailed requirements for you as a manufacturer and for the device itself. The specifications are often available as laws, as guidance documents, as referenced standards as well as information on official websites.

If necessary, get help from your authorization partner, the authorities or a consultancy company.

Documentation requirements

Above all, find out:

• Which documents you have to submit to the authorities
• The required content for these documents
• What form and what language the submission should be made in

Please note that not all countries accept English. For user and service manuals, in particular, countries generally insist on translations into the local language.

Technical requirements for international authorization

It is not uncommon for compliance with country-specific versions of standards to be required. If you know these requirements at an early stage, you can test these requirements, e.g. for IEC 60601-1, at the same time as your regular testing.

Some countries also require additional testing for certain device groups. More detailed research with regard to the following points is often worthwhile:

• Requirements for radio modules
• Requirements for electronic devices
• Novel technologies (e.g., recognition of clinical trials“)

Step 4: Creating documentation

Complete technical documentation is required for a quick and smooth authorization. Although almost every country has its own requirements, there are some common elements, such as:

• Proof of your quality management system
• Device description, including variants
• A clearly defined intended purpose
• Results of the risk analysis
• Instructions for use and labeling
• Results of the device testing, including software verification and validation.

Use the internationally accepted document structures, such as STED, which the ASEAN member states are looking for with the Common Submission Technical Documentation (CSTD).

An alternative is the ToC (table of contents) format from the IMDRF, which is what Canada and China are looking for. The ToC format also covers large parts of the technical documentation required by the MDR.

This gives you a base you can use to extract the necessary information more easily.

Your or your authorization partner submit this documentation to the corresponding authority. If the submission is successful. you will receive confirmation, e.g., in the form of a certificate.

You should first check that the certificate has been issued correctly and that the manufacturer and device information is correct. If an expiry date is given, clarify the format used for this date. It is not uncommon for the month to be given first before the day.

Step 5: Maintaining the authorization

The motto “after the authorization is before the authorization” applies. Therefore, you should determine how much time you need to plan for re-registration.

In addition, a lot of countries expect the authorization to be updated if any modifications are made to the device. Keep a record of when you have to send a modification notification to the authorities.

In most countries, post-market surveillance is an additional requirement for maintaining an authorization. ISO 13485:2016 also requires you to surveil the requirements in countries where you are selling the device.

Determine the requirements for the reporting of incidents and recalls and establish – together with your local partners – corresponding systems.

3. “International authorization” checklist

Each of the above steps requires a set of activities and results. The international authorization checklist helps you:

• Ensure you do not overlook any necessary activities
• Avoid corrections and thus project delays
• Increase regulatory security
• Make the planning of international authorizations easier

International authorization checklist V01Download

4. Conclusion

The international authorization of medical devices poses countless challenges. But good planning helps to identify and overcome these challenges.

A lot of markets are worth the trouble of international authorization. The five steps and the checklist help control the risks as well as the time and effort required for these authorizations.

What are your experiences or the biggest challenges you had to master? We want to hear your experiences of entering the market in new countries, e.g., either in the comment field or by email.

Do you have any questions on international authorization procedures? The Johner Institute's team will be happy to support you every step of the way and, if required, will also take care of the complete authorization process for you. Contact us now.