Evangeline Loh and Stewart Eisenhart09.05.12
The path to market for medical devices in Southeast Asia is about to get a lot easier—or at least a lot more interesting. Ten nations have announced plans to implement a new, harmonized regulatory system by late 2014 in order for the region to facilitate more transparent and efficient market authorizations and improve public access to new and innovative devices.
The regulatory plan has been devised by the Association of Southeast Asian Nations (ASEAN), a regional trade group including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. Known as the ASEAN Medical Device Directive (AMDD), the plan currently exists in draft form. It would establish consistent medical device registration processes across all member states, providing manufacturers with a more predictable path to commercialization throughout the region.
Southeast Asia’s demographic and economic figures make the AMDD a compelling incentive for medical device manufacturers on the lookout for new markets. The ten ASEAN member states have a combined population of about 600 million people, and boast a combined gross domestic product of $2.2 trillion. Currently, however, a medical device firm interested in marketing its product in Indonesia, Malaysia and Thailand, for example, would have to undergo three separate regulatory approvals in each respective country. The AMDD as proposed by ASEAN would establish more uniform regulatory requirements applied across all member states, increasing the likelihood that foreign medical device manufacturers will opt to market their products in multiple Southeast Asian markets.
Classification Under the AMDD
Incorporating elements from the European Union’s Medical Device Directives (MDD 93/42/EEC) and Global Harmonization Task Force (GHTF) recommendations, the AMDD would set up a four-tier classification system for medical devices and in-vitro diagnostic devices for all 10 ASEAN member states:
Conformity Assessments
Evaluating medical devices’ compliance with the AMDD would be accomplished via conformity assessments, according to a draft of the directive. Conformity assessments would be carried out by member states’ regulatory authorities, and member states would bear responsibility for setting up “appropriate” systems to perform conformity assessments.
It is important to distinguish between AMDD conformity assessments and those used in the European Union. The AMDD does not include analogous routes to conformity assessments as in Annexes II through VII of MDD 93/42/EEC. In addition, the AMDD as drafted does not include significant details on conformity assessments, perhaps as a way to permit markets with robust regulatory systems such as Singapore to continue with its system, which includes abridged market pathways for devices already approved by GHTF member countries and registration exemptions for Class A non-sterile and non-measuring devices.
Authorized Representation Mandatory
Although the AMDD would create a single regulatory framework for Southeast Asia, the directive at this point would not go so far as to create a single multi-national market for medical devices such as the European Union. Obtaining marketing authorization in one ASEAN member state does not grant all-in-one access to all member states, in other words. As such, manufacturers with no local presence in the ASEAN member state in which they seek to market their products must appoint in-country representatives to manage their registrations and interact with regulators on their behalf.
Technical Documents for AMDD Registration
The ASEAN directive includes requirements for common technical documentation that device manufacturers and sponsors would have to submit as part of the registration process.
Based on GHTF Summary Technical Documents as well as MEDDEV guidance from the European Union, documents necessary for AMDD registration include ASEAN Common Submission Dossier Templates (CSDT) aimed at harmonizing documentation format discrepancies among different ASEAN member states, eliminating the need to submit multiple dossiers in different formats but with similar or identical content to different Southeast Asian regulators. Note that ASEAN CSDT guidance has existed since 2010.2
Typical components of a CSDT would include the following:
Post-Market Obligations
AMDD compliance would also entail more robust post-marketing requirements for device manufacturers throughout all ASEAN member states. As part of a proposed Post Marketing Alert System (PMAS) that all ASEAN member states would implement, manufacturers would need to maintain distribution and complaint records to improve traceability. Mandatory reporting of adverse events by medical device dealers and healthcare providers is also required under the proposed PMAS, as well as Field Safety Corrective Actions (FSCA, a synonym for recall) in instances where a product owner must take steps to reduce or eliminate risks posed by its device.
Specific PMAS requirements that manufacturers and/or their authorized representatives would have to meet include:
Bottom Line: The Next Frontier for the Industry?
Medical device manufacturers with commercialization strategies in Asia that previously targeted only larger-sized markets such as Japan and China stand to face a far less complex and opaque registration requirement in Southeast Asia following implementation of the AMDD. A more consistent, transparent and cost-effective regulatory framework across all ASEAN member nations deserves serious attention for any manufacturer seeking to expand beyond established (and saturated) medical device markets.
References:
Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at evangeline@emergogroup.com.
The regulatory plan has been devised by the Association of Southeast Asian Nations (ASEAN), a regional trade group including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. Known as the ASEAN Medical Device Directive (AMDD), the plan currently exists in draft form. It would establish consistent medical device registration processes across all member states, providing manufacturers with a more predictable path to commercialization throughout the region.
Southeast Asia’s demographic and economic figures make the AMDD a compelling incentive for medical device manufacturers on the lookout for new markets. The ten ASEAN member states have a combined population of about 600 million people, and boast a combined gross domestic product of $2.2 trillion. Currently, however, a medical device firm interested in marketing its product in Indonesia, Malaysia and Thailand, for example, would have to undergo three separate regulatory approvals in each respective country. The AMDD as proposed by ASEAN would establish more uniform regulatory requirements applied across all member states, increasing the likelihood that foreign medical device manufacturers will opt to market their products in multiple Southeast Asian markets.
Classification Under the AMDD
Incorporating elements from the European Union’s Medical Device Directives (MDD 93/42/EEC) and Global Harmonization Task Force (GHTF) recommendations, the AMDD would set up a four-tier classification system for medical devices and in-vitro diagnostic devices for all 10 ASEAN member states:
- Class A: low-risk devices;
- Class B: low-moderate-risk devices;
- Class C: moderate-high-risk devices; and
- Class D: high-risk devices.
Conformity Assessments
Evaluating medical devices’ compliance with the AMDD would be accomplished via conformity assessments, according to a draft of the directive. Conformity assessments would be carried out by member states’ regulatory authorities, and member states would bear responsibility for setting up “appropriate” systems to perform conformity assessments.
It is important to distinguish between AMDD conformity assessments and those used in the European Union. The AMDD does not include analogous routes to conformity assessments as in Annexes II through VII of MDD 93/42/EEC. In addition, the AMDD as drafted does not include significant details on conformity assessments, perhaps as a way to permit markets with robust regulatory systems such as Singapore to continue with its system, which includes abridged market pathways for devices already approved by GHTF member countries and registration exemptions for Class A non-sterile and non-measuring devices.
Authorized Representation Mandatory
Although the AMDD would create a single regulatory framework for Southeast Asia, the directive at this point would not go so far as to create a single multi-national market for medical devices such as the European Union. Obtaining marketing authorization in one ASEAN member state does not grant all-in-one access to all member states, in other words. As such, manufacturers with no local presence in the ASEAN member state in which they seek to market their products must appoint in-country representatives to manage their registrations and interact with regulators on their behalf.
Technical Documents for AMDD Registration
The ASEAN directive includes requirements for common technical documentation that device manufacturers and sponsors would have to submit as part of the registration process.
Based on GHTF Summary Technical Documents as well as MEDDEV guidance from the European Union, documents necessary for AMDD registration include ASEAN Common Submission Dossier Templates (CSDT) aimed at harmonizing documentation format discrepancies among different ASEAN member states, eliminating the need to submit multiple dossiers in different formats but with similar or identical content to different Southeast Asian regulators. Note that ASEAN CSDT guidance has existed since 2010.2
Typical components of a CSDT would include the following:
- Executive summary;
- Relevant essential principles and method used to demonstrate conformity;
- Device description;
- Summary of design verification and validation documents;
- Device labeling information; and
- Manufacturer information.
Post-Market Obligations
AMDD compliance would also entail more robust post-marketing requirements for device manufacturers throughout all ASEAN member states. As part of a proposed Post Marketing Alert System (PMAS) that all ASEAN member states would implement, manufacturers would need to maintain distribution and complaint records to improve traceability. Mandatory reporting of adverse events by medical device dealers and healthcare providers is also required under the proposed PMAS, as well as Field Safety Corrective Actions (FSCA, a synonym for recall) in instances where a product owner must take steps to reduce or eliminate risks posed by its device.
Specific PMAS requirements that manufacturers and/or their authorized representatives would have to meet include:
- Distribution records: Manufacturers, authorized representatives and distributors must establish and set up procedures for maintaining distribution records, and keep distribution records for each medical device they market. Information such as initial consignee’s name and address, identification and quantity of device shipped, and control numbers of devices shipped should be included in such records;
- Complaint records: Medical device firms and their representatives must keep records of complaints issued against their products; all communications, evaluations and corrective actions must be included in these records. Manufacturers, representatives and distributors must also have written policies in place for complaint handling;
- Adverse events: The AMDD would require reporting of adverse events based on three criteria— that an adverse event has occurred, the medical device associated with the adverse event, and if the adverse event has led to a public health threat, patient death or injury. Adverse event reporting requirements would apply to manufacturers, representatives and distributors; and
- FSCA: Device product owners bear responsibility for deciding whether FSCAs are appropriate, according to the AMDD. Risk assessments compliant with ISO 14971, current version, should be used in such determinations. If a product owner or representative decides to initiate a FSCA, appropriate market regulators must be notified.
Bottom Line: The Next Frontier for the Industry?
Medical device manufacturers with commercialization strategies in Asia that previously targeted only larger-sized markets such as Japan and China stand to face a far less complex and opaque registration requirement in Southeast Asia following implementation of the AMDD. A more consistent, transparent and cost-effective regulatory framework across all ASEAN member nations deserves serious attention for any manufacturer seeking to expand beyond established (and saturated) medical device markets.
References:
- CIA World Factbook, ASEAN website
- www.asean.org/SnC/Guidance%20to% 20ASEAN%20CSDT_Final_21%20Oct%202010.pdf
Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at evangeline@emergogroup.com.