ASEAN Medical Device Regulatory Integration
Countries working to modernize the healthcare industry may easy device entry into Southeast Asia market.
Ames Gross and John Minot
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group of countries prepares to unveil a more unified approach to oversight.
The Association of Southeast Asian Nations (ASEAN) is a political and economic grouping of 10 countries in Southeast Asia comprising Indonesia, Singapore, Malaysia, the Philippines, Thailand, Brunei, Cambodia, Vietnam, Laos and Myanmar. ASEAN has a combined population of about 600 million people and a combined GDP of about $2.6 trillion (adjusted for purchasing power parity). By comparison, the European Union has 500 million people and a $14.7 trillion GDP, and Japan has 125 million people and a $4.3 trillion GDP.
Healthcare is one of the priority industries the association plans to modernize and integrate across the region. ASEAN’s “healthcare integration roadmap” includes lowering tariff and nontariff barriers to trade, harmonizing customs procedures and regulatory regimes, integrating logistics and outsourcing services.
The ASEAN committee responsible for medical device regulatory harmonization is the Medical Device Product Working Group (MDPWG). The MDPWG is one of 12 working groups of the ASEAN Consultative Committee on Standards and Quality (ACCSQ).
The MDPWG’s unified set of rules for medical devices is not yet finalized. However, once these rules are in place, they should increase ease of entry into the Southeast Asian medical device market. The project will institute a common format for medical device application dossiers. This will mean that medical device firms will be able to prepare identical dossiers to submit in each ASEAN country. However, some Southeast Asian countries do not require product approval for most medical devices. In those countries, the ASEAN standards could be a hurdle.
Currently, out of the 10 ASEAN countries, seven have laws or guidelines that govern medical devices; these countries are Singapore, Malaysia, Indonesia, Thailand, Vietnam, the Philippines and Myanmar. The other three countries—Brunei, Cambodia, and Laos—are working on developing laws or guidelines. Even if a country has laws or guidelines for medical devices, that does not necessarily mean medical devices must be registered for sale in that country. For example, in Malaysia, product registration is optional. Registration will become mandatory in Malaysia once a medical devices bill is approved by the country’s parliament.
The overall regulation the MDPWG is crafting to harmonize medical device regulations is called the ASEAN Medical Device Directive (AMDD). The AMDD will not be a law in ASEAN countries, but all member countries will be required to pass laws with the same provisions. The AMDD lays out basic requirements for medical device safety and performance, the medical device classification system, a Common Submission Dossier Template for medical devices (CSDT) and an ASEAN-wide post-marketing alert system.
Product registration is the major focus area of the AMDD. The AMDD’s guidelines are generally based on the guidelines of the Global Harmonization Task Force (GHTF), a committee of government and industry representatives from the United States, Europe, Japan, Canada and Australia. The group works on benchmarking and harmonizing medical device regulations across those countries. The AMDD’s 18 articles are:
1. General provisions
2. Definition and scope of medical devices
3. Essential requirements of safety and performance of medical devices
4. Classification of medical devices
5. Conformity assessment of medical devices;
6. Registration and placement on market
7. Registration of persons responsible for placing medical devices on the markets of member states
8. Technical documents for medical devices (Common Submission Dossier Template (CSDT), Declaration of Conformity, etc.)
9. Relevant technical standards (ISO, etc.)
11. Product claims
12. Post-marketing alert system
13. Clinical investigation
14. Institutional arrangements
15. Safeguard clauses
17. Special cases
In some cases, AMDD requirements are the same as GHTF requirements. Some examples are the definition of what constitutes a medical device, the risk classification system of medical devices from I-IV, and the Essential Requirements of Safety and Performance. These provisions are the same as the GHTF’s equivalent articles. Clinical trial safety requirements, on the other hand, are based on the Helsinki Declaration of 1964. It should be noted that the AMDD treats in vitro diagnostics (IVDs) as medical devices.
The CSDT explains they types of data that must be included in the dossier for device registration in all ASEAN countries. This makes it one of the most significant parts of the AMDD. The main components of the CSDT are:
• Executive summary
• Essential principles and methods
used to demonstrate
• Device description
• Summary of design verification
• Preclinical and clinical data (if
• Device labeling
• Risk analysis
• Manufacturer information
The CSDT is the counterpart of the GHTF’s Summary Technical Documentation.
The two documents are similar, but they are not exactly the same. One difference is the CSDT’s “device description” section contains additional items. They include device counterindications, potential adverse effects and alternative therapies.
Samples of labeling to be used on the device and its packaging materials must be included in the CSDT. All existing instructions for the device (instructions for use, training, installation and maintenance) also must be submitted.
Besides the CSDT, the other major document the AMDD requires for medical device approval is the Declaration of Conformity. This document states that the medical device complies with the Essential Principles of Safety and Performance and also lists the device name, applicable standards for the device, location of test results, manufacturer information and the responsible person for the device. The Declaration of Conformity should be only one page in most cases.
The AMDD also contains guidelines for member governments’ medical device review processes, otherwise known as conformity assessment. As previously mentioned, medical devices must demonstrate they comply with the Essential Requirements of Safety and Performance in order to be approved. In addition, the regulatory authorities in ASEAN member countries are required to review and approve applicants’ internal systems for quality management and post-market surveillance.
Similar to the regulatory systems of Singapore and some other countries, a foreign company applying for medical device approval must have a local office or local agent in the country of application. This local office may be a branch office, subsidiary, or independent distributor, but it must take legal responsibility for the device in that country.
As a rule, local clinical trials should not be required under the AMDD for Class I and II devices. However, local clinical trials may be required in some cases for Class III or IV devices.
The standard language for the CSDT will be English, though labeling materials may be an exception.
Besides registration, the other main component of the AMDD is the post-marketing alert system. This is a system for disseminating information on medical device adverse events and quickly identifying defective or unsafe devices to ASEAN regulators. The AMDD defines the scope of medical device adverse events that should be reported and lists the details that should be included in adverse event reports. Reports will include the device name, level of confidentiality, type of adverse event, action taken, potential effects, original report source, device information, information on the device manufacturer and in-country representative, and the regulatory authority issuing the report.
The system has two levels of post-marketing surveillance. The first level occurs when adverse event reports are being circulated but no investigation has taken place yet; reports at this level are confidential. Once an investigation has taken place, findings are circulated to the public.
There are two significant issues the MDPWG has not yet resolved: language requirements and the use of third-party assessment bodies.
A difficult question for ASEAN is whether medical device labels must be in the local language of the country of marketing. Some countries want English labeling to be the only requirement, while other countries want labels translated into their own languages as well.
MDPWG meetings have been discussing this issue, but there has been no consensus yet. A decision is likely this year. However, even if English is the only requirement in the final draft, labeling in the local language may still be required for devices that are marketed directly to the public.
It has not been decided whether the final AMDD draft will allow for third-party assessment bodies. Some ASEAN members want such independent bodies (similar to notified bodies) to be able to review medical device applications for conformity with the Essential Requirements of Safety and Performance. Other members oppose the idea of third-party assessment bodies.
The AMDD is nearing its final draft, haven taken shape over the course of several MDPWG meetings since the first version was presented in January 2008. The most recent meeting was held last year in Kuala Lumpur, Malaysia. Since the July 2008 meeting, regulators in the MDPWG have been soliciting comments from the medical device industry. They have also been seeking “in-principle” approval of the AMDD from their respective governments in order to speed up implementation of the AMDD once it is ready.
MDPWG’s official goal is to have the AMDD implemented in 2010. That goal, however, depends on the preparedness of the various nations’ regulators. Singapore and Malaysia, for example, have both run optional medical device registration systems for several years, so they will most likely implement the AMDD in 2010 as planned. But other countries, such as Indonesia and Thailand, will probably not be ready by then. 2012 seems to be a more realistic implementation date for those countries. The official deadline for all ASEAN members to comply with the AMDD is 2015.
The Future for ASEAN Integration
The AMDD will not be the final step in ASEAN medical device integration. Additional proposals to advance integration even further are still under discussion. One of these proposals is approval process standardization.This idea would require medical device regulators in all ASEAN countries to use the same dossier template and review product applications based on the same detailed standards. The proposal would make it easier for medical device firms to apply for approval in ASEAN countries because they would not have to change their submissions to satisfy a request for additional information from different countries.
Another idea being discussed is allowing mutual recognition of medical device product approvals across ASEAN countries. Under this proposal, product approval from one ASEAN country could be used to market the same medical device throughout the other member countries. This proposal would eliminate the need to make separate applications in each ASEAN country. However, it would not give foreign firms the ability to have their product automatically approved in all ASEAN countries simply by registering their device in one nation. Only ASEAN countries with more advanced regulatory systems would be designated this role.
Even before such a mutual recognition system exists, prior approval in Singapore should be a significant help for an application in other ASEAN countries.
ASEAN also may later allow expedited approval for devices that have already been approved in the United States, European Union or other advanced countries.
Another idea under consideration is whether to completely integrate ASEAN guidelines with GHTF guidelines. It has been suggested that all ASEAN countries join the GHTF so they could use its guidelines while providing their own input. This, however, is a more long-term proposal.
All proposals will seriously be considered and acted upon after the AMDD is implemented. It is unlikely in the foreseeable future that ASEAN will create a single regulatory body with authority for the entire region.
As ASEAN comes closer to having a common framework for medical device product registration, the parties involved also are building a new regional industry association to reflect the common framework. In 2006, the ASEAN Medical Device Industry Association was initiated and its officers were named last year. This association is designed to serve as the main representative of regional and global medical device firms to ASEAN as it continues with the medical device regulatory harmonization process.
Ames Gross is president and founder of Pacific Bridge Medical. He is recognized nationally and internationally as a leader in Asian medical markets. John Minot is an associate at Pacific Bridge Medical. He works on research and writing projects. Pacific Bridge Medical is a leading independent consulting firm dedicated to assisting medical companies in Asia. To learn more, visit www. pacificbridgemedical.com.