This article was also published on Medical Device Summit
Together, the ten countries of the Association of Southeast Asian Nations (ASEAN) have a combined GDP of $2 trillion and a population of more than 600 million. Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Myanmar (Burma), Cambodia, Laos and Vietnam made up the only region of the world to see higher economic growth in 2012 than in 2011. For 2012, economic growth in ASEAN was more than 5 percent, compared to 2 percent in the US and negative growth in the EU.
Per capita incomes have gone up from Vietnam to Indonesia, and the middle class is rapidly rising across the region. In 2010, ASEAN’s middle class made up 24 of its total population. If current rates hold, the middle class is expected to make up 65 percent of ASEAN’s total population by 2030.
As the middle class has grown, so has demand for more and better quality medical devices. In 2012, the total value of the ASEAN medical device market was more than $4 billion. This is expected to increase to $8 billion by 2017.
But unlike mature markets in the EU and Japan, ASEAN’s market for medical devices is significantly underpenetrated. This will mean many opportunities for foreign medical device companies that can navigate the ASEAN regulatory environment.
THE ASEAN MEDICAL DEVICE DIRECTIVE (AMDD)
One of the biggest challenges to foreign medical device companies doing business in Southeast Asia has been the unpredictable regulatory environment for medical devices. Standards for product registration, distribution and post-market surveillance have varied significantly from country to country, and in some cases (Cambodia, Laos, Brunei and — until recently — Malaysia) have not existed at all.
To unify standards in the medical device industry, the ASEAN Consultative Committee on Standards and Quality (ACCSQ) set up the Medical Device Product Working Group (MDPWG) in 2004. The MDPWG was tasked with putting together a harmonized set of standards for medical device registration and post-market surveillance throughout the ASEAN region.
The MDPWG’s most recent draft regulations — the ASEAN Medical Device Directive (AMDD) — came out in 2012, and implementation is expected by December 2014. The AMDD lays out basic requirements for a harmonized classification system, medical device safety and performance, conformity assessments and a Common Submission Dossier Template (CSDT).
The AMDD is not a legally binding document, but instead acts as a model for member nations, much like the EU Medical Device Directive. The current AMDD was developed with input from member countries, industry representatives and international regulatory bodies like the Global Harmonization Task Force (GHTF) and the World Health Organization (WHO).
MEDICAL DEVICE CLASSIFICATION
The AMDD sets up a risk-based classification system based on GHTF guidelines. According to the AMDD, medical devices — including in-vitro diagnostics (IVDs) — will fall into one of four categories:
- Class A (low risk devices like tongue depressors)
- Class B (low-moderate risk devices like hypodermic needles)
- Class C (moderate-high risk devices like lung ventilators)
- Class D (high risk devices like heart valves)
Classification determines fees, processing times and clinical requirements. Currently, these issues vary among ASEAN countries. Individual countries may set up their own expedited registration channels under the AMDD framework, and they will have final authority over any classification disputes that may arise during the registration process. However, it is expected that many ASEAN member countries will follow the lead of Singapore, which has already implemented many of the AMDD directives.
Under the proposed AMDD, all member countries must establish an AMDD compliant system for assessing medical devices. According to the current draft, conformity assessments may be carried out by the main regulatory body of member state itself, or by a third party appointed by the member state.
Additionally, all product registration applications should be submitted by an in-country representative of the device manufacturer. If the manufacturer does not have an office in a particular member country, then it must appoint a local agent as its authorized representative.
Technical documents required by the AMDD include:
- ASEAN Common Submission Dossier Template (CSDT)
- Post-Marketing Alerts System (PMAS) information
- Declaration of Conformity (DoC) from the product owner or manufacturer
- The component elements of a “Dear Healthcare Professional” letter. This letter informs healthcare professionals of new warnings, safety information and changes to the prescribing information or labeling of a medical device
- Letter of Authorization for appointing a local representative
COMMON SUBMISSION DOSSIER TEMPLATE
The CSDT guidelines are the most significant part of the AMDD, as they lay out requirements for all data to be included in medical device registration. The CSDT eliminates the need to prepare multiple dossiers in different formats for each of the ASEAN countries. Application information includes:
- An executive summary (including a commercial marketing history of the medical device and a list of regulatory approval or marketing clearances already obtained)
- An Essential Principles conformity checklist
- A device description, including intended use and indications, instructions for device use, warnings and precautions, potential adverse effects, alternative therapy and materials and relevant specifications
- Design validation and verification documents (such as engineering and biocompatibility tests), including the results of pre-clinical and clinical studies, software validation and verification studies, clinical evidence and relevant bibliography references
- Samples of device labeling and packaging and instructions for use
- Risk analysis
- Manufacturer information (including details on the manufacturing process)
All information in the CSDT should be in English, though labeling materials may appear in the national language of the country in which the application is made. According to the draft AMDD, each country has the authority to require medical device labeling in the local language.
POST-MARKETING ALERT SYSTEM
In addition to setting up pre-market requirements, the AMDD also sets forth a list of documentation requirements for complaints and adverse events. Manufacturers, authorized representatives and distributors are required to maintain distribution and complaint records. They must also conduct “effective and timely” investigations of reported problems, and keep all records of inspection for the regulatory authority of the member state.
Medical device dealers and healthcare professionals are obligated to report on all adverse events related to the malfunction or deterioration of a medical device. Once notified, regulatory bodies are responsible for investigating the event. In coordination with the product owner, they must then notify other ASEAN countries of the event as well as any corrective actions taken.
However, member states are free to follow the recommended post-marketing alert system or set up a system of their own.
While many details of the AMDD are left to member countries, the important details of classification and data requirements are the same for every country in the ASEAN region. Although this will place an additional burden on foreign device manufacturers selling to countries like Cambodia (which formerly had no system for registering medical devices), it will also, hopefully, establish a common registration system and reduce uncertainty in the market. Further, the AMDD may open the door to other forms of regulatory integration within ASEAN, such as integrated abridged registration processes and common product approval procedures.