Don’t be labeled “Non-Compliant” when marketing medical products internationally

Traversing through the maze of regulations when it comes to domestic (US) labeling requirements can be extremely involved. As medical product manufacturers market their products internationally, this task becomes even more daunting. Remember, labeling in the medical industry is not only isolated to “what is on the box”. International bodies (i.e. European Union and the Japan Ministry of Health, Labour and Welfare) define labeling very much the same as the US. FDA:

The Federal Food, Drug and Cosmetic Act (FFDCA) Section 201(k) defines “label” as a “display of written, printed, or graphic matter upon the immediate container of any article...” As we see, this pertains to “what is on the box”; however, Section 201(m) defines “labeling” as


“all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.”

As one considers what is needed to be done to maintain compliance with international regulations, one must consider three important factors:

1- International labeling regulations from the Ministries of Health differ (if only slightly) from US Domestic FDA regulations. Harmonization efforts have been pursued for many years now but full harmonization has not been accomplished. Don’t assume that because you r labeling is compliant with the US FDA that it is also compliant with International Ministries. Many international bodies will accept compliance with the US FDA standards; however this is not an “across the board” scenario.

2- Many times there are labeling requirements for Import/Export in addition to the labeling requirements for the Ministries of Health. These governmental requirements must be considered in order to ship product into a country independent of what is required to market and sell the products once they are received in-country.

3- There ARE language requirements for labeling in every country.

The first two points above are pretty straightforward and are firsthand knowledge to Regulatory Affairs professionals who have years of experience in the medical industry. However, point #3 is not always as straightforward as it may seem. Let’s take a brief look at what is involved.

Each country has an official language in which labeling MUST be written. There are some countries where the official language is English. In the cases where the official language is not English, the defense that all operators, end users, physicians, technicians, patients, etc. read and write English is not acceptable. A manufacturer simply cannot vouch for the level of English comprehension of the different groups of people previously listed. If there is an adverse event (someone is hurt or killed- i.e. patient, doctor, nurse, technician, etc) and the cause of this adverse event is traceable back to the labeling was translated incorrectly or not translated at all, the manufacturer is liable. Claiming not to know what languages are spoken in different countries is not an excuse either. Each country has an official language or official languages that are accepted; however, do not just assume that these are the languages in which your labeling needs to be written. There are exceptions, depending upon your product or how it is being distributed (sold for commercial use vs. investigative) that also must be taken into consideration. The best way to start is to first understand what the official language(s) are for the countries you will be marketing then check the requirements released by the Ministry of Health for that country. Your government agent (or Notified Body for EU) within the country or region will provide official guidance. Your medical translation partner, although unable to provide official guidance, can also point you in the right direction (unofficially) with their experience working with other medical manufacturers (i.e. we have many clients who sell products in X country and the languages they translate into are Y.)

Do not think you chances of getting caught being non-compliant are slim to none. Apart from an adverse event triggering six to sever figure law suits and recalls, investigations can be launched based upon government audits, custom officials, competitors, or unhappy customers. The benefits far outweigh the risks maintaining compliance with international labeling requirements.

Drastic Changes to EN ISO 14155:2003 to Impact Medical Device Manufacturers

EN ISO 14155:2003 is the European Standard dating from 2003 which governs Clinical Investigation of Medical Devices for Human Subjects. Manufacturers must use this standard to demonstrate compliance with EU requirements for clinical investigations detailed in the medical device directives. The International Organization for Standardization (ISO) is currently voting on the adoption of a revised version of the standard, which, if approved, will affect all medical device manufacturers. If adopted, the revised standard will become the standard of reference for conducting medical device clinical studies in the United States, Japan and other countries.

First and foremost, the revised standard will have a new title: “Clinical investigation of medical devices for human subjects — Good clinical practices.” It will also be available as a single document (the former standard was divided into two parts) and will be twice as long as the previous version. The document now includes nine clauses (instead of 15 in the previous version) and eight annexes instead of four in the 2003 version.

Worthy of note is also the fact that new requirements have been added to the standard: they deal for the most part with sponsor responsibilities, informed consent for vulnerable subjects, Ethics Committees, study monitoring, electronic data management and risk management. The revised standard stresses the fact that it applies to all clinical investigations and should be followed not only when clinical studies are needed to generate clinical study data, but also when studies are conducted for other reasons.

If adopted, medical device manufacturers should examine carefully the changes affecting ISO 14155 in the final standard, which will be harmonized in the EU. The expected revision of ISO 14155 will have a profound effect on the way medical device manufacturers will be conducting medical device studies worldwide and should not be ignored.

Mass communication is not as effective anymore. Advertising saturation and audience segmentation make it more and more difficult for companies and brands to reach their target consumers. Traditional marketing tools are confronted with new communication and information technologies that allow a two-way and interactive communication. Consumers are increasingly knowledgeable and demanding and skillfully control online media. The IMC (Integrated Marketing Communications) approach is born in this context in the attempt to find new ways of reaching out to target audiences.

IMC (Integrated Marketing Communications) and Translation

Mass communication is not as effective anymore. Advertising saturation and audience segmentation make it more and more difficult for companies and brands to reach their target consumers. Traditional marketing tools are confronted with new communication and information technologies that allow a two-way and interactive communication. Consumers are increasingly knowledgeable and demanding and skillfully control online media. The IMC (Integrated Marketing Communications) approach is born in this context in the attempt to find new ways of reaching out to target audiences.

Integrated communications build up the foundation of a marketing strategy that pursues to deliver a cohesive and unified message with the aim of achieving a recognized and solid brand identity with a unique market positioning. The key is to strategically control and influence all messages produced by the company (throughout its own employees as well as throughout its customers and other stakeholders) using multiple media and channels. Customers are at the core of this strategy that seeks long-term relationships based on partnership and loyalty to the brand. The clarity, consistency and impact of the communication effort will determine the brand and company’s position on consumers’ minds.

How are clarity, consistency and maximum impact achieved internationally in all markets where the company operates? It will be obviously necessary to know and understand the lifestyle and behavior of target consumers as well as their media habits. Mass media advertising has traditionally resorted to visual language, but an integrated approach that intends to optimize communication with consumers, employees and all company stakeholders alike, cannot be limited to the use of images. Companies need to talk the languages used in their target markets and translation cannot be considered a secondary communication tool anymore. It is a requirement to create brand value and an unrivaled competitive advantage amidst the fierce competition of the international market.

Excel Translations is the Market Leader in ISO 9001- and ISO 13485-certified Translation Services. We provide the required hardware and software expertise as well as the in-depth knowledge of language, regulatory requirements, cultural nuances and taboos, and linguistic connotations to make the translated software application as functional for the foreign user as it is for the domestic user. Excel Translations' localization engineers routinely work with software resource and online help localization projects on Mac, Windows, NT, and Linux operating systems. Contact us for more information about our medical translation services.

SNOMED CT (Systematized Nomenclature of Medicine -- Clinical Terms)

In the years since Obama became president, the words 'electronic health care records' have been uttered and written many times. Usually they have been used in a positive context, as a factor capable of reducing health care cost and improving efficiency. It's hard to find anyone who want to retain handwritten paper medical records, and the poor legibility and consequential medical errors that come with it. Among other benefits, electronic health records help standardize forms and terminology; they facilitate data input as well as the collection, analysis and application of such data for the benefit of the individual patient (treatment) and the patient population (clinical studies).

In the years since Obama became president, the words 'electronic health care records' have been uttered and written many times. Usually they have been used in a positive context, as a factor capable of reducing health care cost and improving efficiency. It's hard to find anyone who want to retain handwritten paper medical records, and the poor legibility and consequential medical errors that come with it. Among other benefits, electronic health records help standardize forms and terminology; they facilitate data input as well as the collection, analysis and application of such data for the benefit of the individual patient (treatment) and the patient population (clinical studies).

The last years have shown an acceleration in the development of a powerful new tool in establishing uniformity in electronic health records. Enter SNOMED CT (Systematized Nomenclature of Medicine -- Clinical Terms), a systematically organized computer-processable collection of medical terminology that covers an impressive area of clinical information such as diseases, findings, procedures, microorganisms, pharmaceuticals etc. The goal of SNOMED CT is to support the development of electronic health records systems that allow for a correct retention, processing and exchange of unambiguous clinical records. There is a need to exchange clinical information consistently between health care providers, care settings and researchers and because medical information is recorded differently from place to place (on paper or electronically), a comprehensive, unified medical terminology system is needed as part of the information infrastructure.

Clinicians and organizations use different clinical terms that mean the same thing. For example, the terms heart attack, myocardial infarction, and MI may mean the same thing to a cardiologist, but to a computer, they are all different. SNOMED CT is considered to be the most comprehensive, multilingual clinical healthcare terminology in the world and it allows a consistent way to index, store, retrieve, and aggregate clinical data across specialties and sites of care. It also helps organizing the content of medical records, reducing the variability in the way data is captured, encoded and used for clinical care of patients and research.

Each year, avoidable deaths and injuries occur because of poor communication between healthcare practitioners. The delivery of a standard clinical language for use across the world's health information systems can therefore be a significant step towards improving the quality and safety of healthcare. SNOMED CT aims to improve patient care through the development of systems to accurately record health care encounters. Ultimately, patients will benefit from the use of SNOMED CT, for building and facilitating communication and interoperability in electronic health data exchange.

SNOMED CT Abroad

Excel Translations is the Market Leader in ISO 9001- and ISO 13485-certified Medical Translation Services. We provide the required hardware and software expertise as well as the in-depth knowledge of language, regulatory requirements, cultural nuances and taboos, and linguistic connotations to make the translated software application as functional for the foreign user as it is for the domestic user. Excel Translations' localization engineers routinely work with software resource and online help localization projects on Mac, Windows, NT, and Linux operating systems. Contact us for more information about our medical translation services.