By requiring mandatory CE marking, the Medical Device Directive 93/42/EEC has greatly contributed to the harmonization of regulatory requirements in the 27 EU member states. By contrast, the regulatory requirements in the emerging markets outside of the European Union are prone to change and vary substantially from country to country. New regulations for medical devices in the emerging markets often pose major challenges for the medical device industry. The combined region of Europe, Africa, and the Middle East is characterized by a multitude of cultures, languages, and regulatory requirements.
The European Union: The Promised “CE Land”?
A growing number of countries are demanding national registration of medical devices. The reason for this demand is understandable: The national authorities desire a high level of transparency for medical devices marketed in each respective country. In the European Union, for example, the marketing of medical devices is subject to national registration in Italy, France, Hungary, Spain, and Poland. This obligatory registration is costly, sometimes requiring almost as much investment in expense and effort as the CE certification itself.
For example, the national laws of all 27 EU member states require translation of product information into the native language of each particular country. With the transposition of the Medical Device Directive 93/42/EEC, translation of all printed documents is obligatory, including package inserts and screen contents. Essentially, product labeling must be available in 23 languages to comply with the requirements of the EU member states if the device is intended to be sold in all EU member states. It is still possible to sell a product with just one language, provided this product is exclusively sold to the single country where the inhabitants speak that language. For example, if a company intends to exclusively sell in Italy, Italian-only product labelling is acceptable).
Beyond Schengen: Outside the European Union
Many previously unregulated markets are also extending their legislative texts and requirements. As a result, new laws relating to the requirements for medical device registration have already come into force in Turkey, Ukraine, Russia, Egypt, Saudi Arabia, Jordan, Croatia, and Serbia. This has resulted in increased costs for the compilation, submission, and follow-up for documents required for local registration. Also, these recently created regulations, which are often based on those applicable to medicinal products, are a major challenge because the corresponding authorities are in many cases newly created. It is frequently suggested by industry experts and industry associations that the authorities themselves are not yet au fait with the complexity of the new rules. The situation, however, still offers the possibility of exerting some influence on the authorities and, accordingly, on future rules through teaching, seminars, meetings, and soon, industrial associations such as Eucomed, in Europe; AdvaMed, in the United States; and Mecomed, in the Middle East. These associations are helpful platforms that enable effective cooperation between the industry and authorities. They also make it possible to stimulate meaningful discussions on the potential implications of new laws.
Individual companies are striving to explain existing regulatory systems to individual national authorities.
For example, representatives from the regulatory affairs departments of three Abbott divisions recently provided training to the Jordanian FDA on the Global Harmonization Task Force (GHTF) and the regulatory systems in Europe and the United States. The training covered several device types and was well received by the Jordanian authority. Similar training supported by industrial associations is currently planned for staff officials, including the review staff at the Egyptian Ministry of Health. Product-specific training may help authorities with product evaluation and, thus, support and accelerate the registration process.
Many medical device manufacturers trade globally. Consequently, there is much interest in promoting transparency and harmonization among the regulatory systems of individual countries. A proliferation of country-specific rules would lead to enormous complexity, high costs, and delays in market access for companies acting on a global level.
No Risk, No Fun
Investment in a new market always poses a risk. For small companies taking their first step into a market, registering and distributing products through a distributor can help substantially reduce these risks. The product, however, must meet the requirements in the country, such as the necessary certificates and product labeling.
Many medical technology companies view Turkey, Russia, Ukraine, Egypt, Saudi Arabia, and the United Arab Emirates as emerging markets. Despite the possible opportunities arising from the development of new markets, some of the regulations may pose difficulties.
Possible Pitfalls of Cooperation with a Distributor
Even if cooperation between a company and a distributor initially appears to be perfectly pleasant, the devil is often in the seemingly trivial details. If one relies exclusively on information from the distributor regarding the current state of national legislation and the documents required for registration, the information may not be completely accurate. This has to do with incentives: The distributor gains revenue from the sale of medical products—not from spending time with an authority to figure out national laws applicable to the products targeted for import. Also, the distributor is not usually an expert in regulatory matters. It cannot be assumed or expected that subtle details and nuances of the rules among several emerging markets will be understood and implemented correctly. A healthy amount of mistrust makes sense here. It is likely that a distributor will know more about customs guidelines for the importation of goods.
Language issues may represent an important obstacle in some emerging markets: the distributors’ staff members often do not speak English sufficiently. Even if they thoroughly understand their market and customers, communication may still be difficult.
Communication by telephone between the company and distributor represents a challenge that should not be underestimated. First, the time difference can be several hours between countries throughout Europe, Africa, and the Middle East. In addition, negotiations between Arabic and Central European business partners can only take place a maximum of four days a week because the weekends in these different regions do not necessarily coincide.
If it is believed that e-mail is the path to the philosopher’s stone, it should be noted that using e-mail can prove challenging when dealing with certain Slavic countries. A high amount of spam e-mail is sent with the country suffixes .ru (for Russia) and .ua (for Ukraine). This has resulted in the information technology (IT) equipment of many companies and e-mail providers immediately transferring e-mails with these country suffixes to the spam folder. These folders must, therefore, be monitored to ensure that important registration documents are not missed. Companies should have their IT department configure the computer network firewall settings to minimize such delays. The storage period for e-mails in the spam folder may need to be adjusted so that messages can be retrieved at regular intervals.
As in the European Union, there is a growing tendency for local labeling of products in the emerging markets cited above. All product information frequently must be available in the local language. The review process for labelling materials is often lengthy and unpredictable. The evaluation often takes longer than 12 months. There are usually substantial intercountry variations in the compilation of the necessary documents and certificates. Many countries even request information and certificates that actually originate from the Medicinal Products Act and are often not relevant for medical devices. For example, the “active ingredients” question is quite a challenge to answer when submitting medical lasers or phacoemulsification machines used for cataract surgery. Significant variations in country requirements apply not only to documents but to the review of such documents, including those certified, notarized, or apostillized. All of this adds to the complexity of regulatory submissions in emerging markets.
Regulatory Details from Emerging Markets
To record the ongoing temperature exposure and humidity of temperature-sensitive medical devices during transport, temperature loggers or humidity loggers (small probes activated on dispatch of the goods) can be included with the products. At the destination, customs officers or a corresponding authority can read the data and release the goods subject to adherence to temperature and humidity limits. If these loggers are missing from the shipment, manufacturers or distributors must arrange for complicated, costly, and time-consuming local testing of the goods to release them through customs. South African law prescribes clear requirements for the inclusion of temperature loggers for products that must be stored between 2°C and 8°C. Even though obligatory temperature loggers have long been discussed in Jordan, Saudi Arabia, Lebanon, and the United Arab Emirates, these countries do not currently require measurement devices.
Saudi Arabia. Saudia Arabia’s new interim law on medical devices came into force on April 10, 2010, and includes an obligatory, complex registration of all medical devices to be imported into the country. Registration is Internet-based. The start date of this registration procedure was September 1, 2010.
The deadline for completed registration was February 28, 2011, after which, medical devices are permitted to be placed onto the market only if they have received marketing authorization by the Saudi Food & Drug Authority (SFDA). After June 30, 2011, use of new medical devices will be subject to SFDA approval. Medical devices already in use at the time of this deadline may still be used. Detailed information on the SFDA marketing authorization process or the fees payable for registration was not available at the time of publication. Further information can be found on the SFDA Web site at www.sfda.gov.sa/en/medicalequipments
United Arab Emirates.
Product registration in the United Arab Emirates is subject to completion of two special forms: one for registration of the manufacturer and the other for registration of the product. These include an arbitrary selection of questions originating from the Medicinal Products Act. Questions are not necessarily device-specific and, therefore, can include a request for a GMP certificate, which is usually available for medicinal products but not for medical devices. Registration usually takes from 9 to 12 months. Current guidelines can be found at the following Web site: http://dcc.org.ae/admincp/assetsmanager/files/pharmacusts/medicaldeviceguidlinesforuae.pdf
Egypt. Egypt poses a particular challenge for licensing medical devices. The Egyptian Ministry of Health is responsible for the registration and approval of medical devices. Licensing registration approval is carried out by the Drug Policy and Planning Center (DPPC) and Central Administration of Pharmaceutical Affairs (CAPA). The Egyptian Ministry of Health began applying strict guidelines to registration requirements for medical devices in January 2005. The rules have been created to reduce the number of forged certificates submitted with registration applications. The new rules have enabled early recognition and, thus, the removal of forged CE and FDA certificates. Such restrictions have sped up the process because the reviewers can concentrate exclusively on legally acceptable submissions.
The following characteristics describe the registration process in Egypt:
- Medical devices that are imported must be registered with the health authority.
- Egypt has adopted the European system for classifying the risks of medical devices (class I, IIa, IIb, and III).
- A free sale certificate is as necessary as the CE mark or FDA approval.
- Submissions for class III–medical devices must include the technical documentation.
- Devices manufactured locally must be clearly labeled as such.
- Submissions for complex medical devices may be forwarded to a special committee.
- The import of used or refurbished medical devices is permitted subject to prior approval by the Ministry of Health.
Turkey. As briefly described earlier, Turkey registers all medical devices to be imported in a national database as well as in its Ministry of Health database, making product approval laborious and costly. As part of Turkey’s EU application, national laws have been harmonized with those of the European Union. This process is not yet complete and there are still discrepancies between the systems. The regulatory environment in Turkey is complex and the corresponding processes are more detailed than in most Middle Eastern states. When planning its health system, the government’s aim was to create a uniform system by 2013 as part of the ongoing reforms of the health sector. In 2006, the government founded the Social Security Institution (SSI), which effectively combines various social security and health insurance organizations. The Ministry of Health home page can be found at www.saglik.gov.tr/en.
Ukraine. Medical devices to be marketed in Ukraine must be registered (www.moz.gov.ua/en), and some of the information is available in Latin script. The legal changes applicable to marketing medical devices came into force on March 17, 2010. Apart from the change of registration body, there were no alterations to the existing process. Registration is now the responsibility of the newly formed State Medical Inspection. As in almost all other countries in the region, labeling must also be in the national language.
Russia. Russia established its Federal Law on Technical Regulating in 2003. With an extended transition period through 2011, the new law on medical devices is in the process of being developed. Currently, the old approach remains in force, with the obligation to comply with GOST R standards until the end of the transition period. These standards require registration of the medical device, followed by GOST R certification. Medical devices will be registered with RosZdravNadzor (the Russian Federal Service on Surveillance in Healthcare and Social Development) in the Ministry of Health (www.roszdravnadzor.ru), with the aim of ensuring the clinical efficacy of the product and its compliance with current Russian health standards. GOST R certification is intended to ensure that products fulfill safety and performance requirements. Because the Russian system is currently in a transition phase, many registration requirements may be regarded as controversial and are interpreted at the time of registration.
Kazakhstan and Belarus. The Commonwealth of Independent States countries Kazakhstan and Belarus each adopted the New Law on Medical Devices in July 2010 and May 2010. In many respects, both laws are in line with the Medical Devices Directive (MDD) but differ in that neither includes any reference to harmonized standards nor mention of market surveillance.
The cooperation of countries that have joined the Eurasian Economic Community will be finalised with its legislation in 2011. In this regard, Russia, Kazakhstan, Belarus, Uzbekistan, Kyrgyzstan, and Tajikistan are planning to achieve a common market with common conformity marks and a uniform conformity evaluation process in line with that of the European Union.
Keeping Track: A Summary
As is so often the case, the phrase “knowledge is power” is particularly relevant when it comes to meeting the reglations of emerging markets. The creation of a specific, coordinated database containing a summary of the complex information and requirements of each country is essential for such a complex subject matter. The table on this page briefly summarizes the regulatory situation in selected countries. Please note that this overview is not intended to provide a complete listing of registration requirements. Also, regulations and requirement in these countries are subject to change; the following information should, however, provide a helpful overview.
|Official authority website
||CE, DoC, FSC,
||All products of
a company must
be submitted at
the same time
||CE, ISO 13485, FSC, DoC
|CE, ISO 13485, FSC, DoC
||CE, ISO 13485
||CE, ISO 13485, DoC
|CE, ISO 13485, DoC, Site
Master Files, GMP, FSC,
Application form, MD
OEMs working on gaining market share need reliable information so their products can be imported legally into a particular country. To obtain currently valid information on the applicable rules, the authors strongly recommend cooperation with, for example, the licensing authorities, the foreign office, and the embassies. Current and valid contact data, contact partners, and telephone numbers for these bodies are easy to find on the Internet.
Typically, there are no fees required for such interactions. However, neutral consultants usually charge a fee for their help. It’s worth noting that such consultants have varying contractual requirements. The services of a consultant, however, may be extremely helpful answering questions and submitting registration forms. Consultants are an effective and efficient means of obtaining rapid and reliable information. When relying on distributors for registration, it is worthwhile to verify that their registration practices and documentation requirements meet those currently in force in the target markets.
Membership of industrial associations that are particularly involved in the emerging markets is also extremely effective because they can enable effective exchange of experiences and provide support with the special requirements of these countries. The Eucomed Emerging Markets Workgroup (www.eucomed.org) and the Industrial Association of the Near/Middle East, Mecomed (www.mecomed.net), play an active, leading role in this regard. Membership ensures an efficient supply of current information and offers a platform that enables industry representatives to exchange and discuss current experiences and raise issues that require clarification.
Registration of medical devices in emerging markets can be exciting, dynamic, and profitable. To comply with the multitude of local regulatory requirements, a clear database is essential for storage of country-specific information, which, is regularly checked and updated. A well-trained professional network, together with perfect legal surveillance of these markets, is essential, even for relatively small companies. This will ensure that working with these markets is not a double-edged sword.
Sibylle Scholtz is the manager of regulatory affairs for EMEA at Abbott Medical Optics (Ettlingen, Germany). Renate Ell is coordinator of regulatory affairs for EMEA/International (Ettlingen, Germany). Stefan Menzl is director, international of regulatory affairs at Abbott Medical Optics.