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 ten countries making up all of Southeast Asia: 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 EU has 500 million people and a $14.7 trillion GDP, and Japan has 125 million people and a $4.3 trillion GDP.
ASEAN’s goals include promoting mutual economic development and competitiveness in Southeast Asia. By eliminating trade and investment barriers within the region and harmonizing industry and Southeast Asia medical device regulations, the group’s overall plan is to make the region a huge unified manufacturing and trading base fully integrated into the global economy.
Healthcare is one of the priority industries that ASEAN plans to modernize and integrate across the region. ASEAN’s “healthcare integration roadmap” includes lowering tariff and non-tariff barriers to trade, harmonizing customs procedures and regulatory regimes, integrating logistics and outsourcing services, etc. This article describes the details of ASEAN’s ongoing project to create a single Southeast Asian regulatory regime for medical devices.
ASEAN Medical Device Regulatory Integration
The ASEAN committee responsible for harmonization of Southeast Asia medical device regulation is the Medical Device Product Working Group (MDPWG). The MDPWG is one of the 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. Specifically, the project will institute a common format for medical device application dossiers. This will mean medical device firms can prepare identical dossiers to submit in each ASEAN country. At the same time, however, some Southeast Asian countries currently do not require product approval for most medical devices. In those countries, the ASEAN standards will be a new hurdle to marketing.
Currently, out of the 10 ASEAN countries, 6 have laws or “administrative guidelines” that govern Southeast Asia medical device regulations. These countries are Singapore, Malaysia, Indonesia, Thailand, Vietnam, the Philippines, and Myanmar. The other 3 countries – Brunei, Cambodia, and Laos – are currently working on developing laws or guidelines. Right now, even if a country has laws or guidelines for medical devices, that does not necessarily mean medical devices must be registered to be sold in that country. For example, in Malaysia, product registration is only optional at present. (Registration will become mandatory in Malaysia once the Medical Devices Bill is approved by Parliament in late 2008 or early 2009.)
The overall regulation the MDPWG is crafting to harmonize Southeast Asia medical device regulation is called the ASEAN Medical Device Directive (AMDD). The AMDD will not be an actual law in the 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 postmarketing alert system.
Product Registration
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 US, Europe, Japan, Canada, and Australia, which works on benchmarking and harmonizing Southeast Asia medical device regulations across countries. The AMDD’s 18 articles are as follows:
- General provisions
- Definition and scope of medical devices
- Essential requirements of safety and performance of medical devices
- Classification of medical devices
- Conformity assessment of medical devices
- Registration and placement on market
- Registration of persons responsible for placing medical devices on the markets of member states
- Technical documents for medical devices (Common Submission Dossier Template (CSDT), Declaration of Conformity, etc.)
- Relevant technical standards (ISO, etc.)
- Labeling
- Product claims
- Postmarketing alert system
- Clinical investigation
- Institutional arrangements
- Safeguard clauses
- Confidentiality
- Special cases
- Implementation
In some cases, AMDD requirements are exactly 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 exactly the same, word for word, 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 sets out what data will be required in the single dossier usable 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 as follows:
- Executive summary
- Essential principles and methods used to demonstrate conformity
- Device description
- Summary of design verification and validation
- Preclinical and clinical data (if necessary)
- Device labeling
- Risk analysis
- Manufacturer information
The CSDT is the counterpart of the GHTF’s Summary Technical Documentation (STED). The two documents are very similar but not the same. One difference is that the CSDT’s “device description” section contains additional items. The additional items include device counterindications, potential adverse effects, and alternative therapies.
According to Southeast Asia medical device regulation, in the CSDT actual samples of the labeling to be used on the device and its packaging materials must be included. All existing instructions for the device (instructions for use, training, installation, and maintenance) must be submitted as well.
Besides the CSDT, the other major document the AMDD requires for medical device approval is the Declaration of Conformity. This document simply 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 just one page in many cases.
The AMDD also contains some guidelines for member governments’ review processes for medical devices. The process is called conformity assessment. As mentioned above, to be approved, medical devices must demonstrate that they comply with the Essential Requirements of Safety and Performance. In addition, the regulatory authorities in ASEAN member countries are supposed to review and approve applicants’ internal systems for quality management and post-market surveillance.
Similar to the current regulatory systems of Singapore and some other countries, a foreign company applying for medical device approval will need to 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; more details are below under “Unresolved Issues.”
Postmarketing Alert
Besides registration, the other main component of Southeast Asia medical device regulations by the AMDD is the postmarketing alert system. This is a system for disseminating information on medical device adverse events to ASEAN regulators and quickly identifying defective or unsafe devices. The AMDD defines the scope of medical device adverse events which should be reported, and lists the details which 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 postmarketing surveillance. The first level is when adverse event reports are being circulated but no investigation has taken place yet. Reports at this level will be confidential. Then, after an investigation has taken place, findings will be circulated to the public.
Unresolved Issues
There are two significant open issues which the MDPWG has not yet resolved on Southeast Asia medical device regulations. These issues are 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 is no consensus yet. A decision will probably be made at the next meeting in January 2009. 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 to the public directly.
In addition, 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 do not favor this. Again, the issue of Southeast Asia medical device regulations will hopefully be resolved at the January 2009 meeting.
Project Status
The AMDD has taken shape over the course of a number of MDPWG meetings since the first draft was presented in January 2008. It is now nearing its final draft. The next meeting will be held in January 2009 in Kuala Lumpur, Malaysia. Since the last meeting in July 2008, the 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 implementation of the AMDD once it is ready.
How soon will the AMDD be implemented throughout ASEAN? The official goal of the MDPWG is 2010. However, the reality will depend on how prepared the various nations’ regulators are. Singapore and Malaysia, for example, have both already run optional medical device registration systems for a few years, so they should be ready quickly. They will probably implement the AMDD in 2010 as planned. However, some other countries like Indonesia and Thailand will probably not be ready by then. For them, 2012 is a more realistic implementation date. The official deadline for all ASEAN members to comply with the AMDD will be 2015.
The Future for ASEAN Integration
The AMDD will not be the final step in ASEAN Southeast Asia medical device regulation integration. Additional proposals to advance integration even further are still under discussion. One of these proposals is approval process standardization. In other words, in addition to using the same dossier template, medical device regulators in all the ASEAN countries would be required to review product applications based on the same detailed standards. This would make it even easier for medical device firms to apply for approval in different ASEAN countries, since they would not have to change their submissions depending on additional information different countries might ask for.
Another proposal is to allow mutual recognition of medical device product approvals across ASEAN countries. Under this proposal, after a device gets approval from a single ASEAN country (e.g., Singapore), that country’s approval could be used to market the same device across the rest of ASEAN. This proposal would eliminate the need to make separate applications in each ASEAN country. However, it would not mean that foreign firms could pick any ASEAN country to register their products in and automatically be approved for all of ASEAN. Rather, only ASEAN countries with more advanced regulatory systems would be designated to play this role.
Even before such a mutual recognition system exists, prior approval in Singapore should be a significant aid for an application in other ASEAN countries.
ASEAN Southeast Asia medical device regulations may also later allow expedited approval for devices which have already been approved in the US, EU, or other advanced countries.
Another topic of discussion is whether to completely integrate ASEAN guidelines with GHTF guidelines. It has been suggested that the ASEAN countries could all join the GHTF, so that they could use its guidelines while providing their own input. This is a more long-term proposal.
All of the above proposals will come after the implementation of the AMDD, if at all. It should be noted that it is not likely 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 Southeast Asia medical device regulation and registration, the parties involved are also building a new regional industry association to reflect the common framework. In 2006, the ASEAN Medical Device Industry Association (AMDIA) was initiated. In 2008, its officers were named. This association is designed to be the main representative of regional and global medical device firms to ASEAN as it continues with the medical device regulatory harmonization process.