Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Requirements for Medical Devices in Southeast Asia and China ***

Dr. Claudia Matthies (Abschlußjahr: 2010)

Summary
The rapidly growing economies of the Southeast Asian countries offer attractive opportunities for the marketing of medical devices: Increasing affluence across Southeast Asia is expected to lead to a growing demand in health care products, like for example medical devices.
This master thesis presents the current regulatory requirements for medical devices in the member countries of the Association of the Southeast Asian Nations (ASEAN) as well as Hong Kong SAR and China. ASEAN represents the following Southeast Asian countries: Singapore, Malaysia, Indonesia, Thailand, the Philippines, Vietnam, Laos, Brunei, Cambodia and Myanmar.
To place a medical device on the market in any of these countries, highly diverse regulatory requirements have to be met at the present time: Out of the 10 ASEAN member states only five have medical device laws (Singapore, Indonesia, Thailand, the Philippines, Vietnam), while one maintains a voluntary registration system using administrative guidelines (Malaysia). The remaining four countries do not have laws or guidelines specifically aimed at medical devices at all. Similar to Malaysia, Hong Kong SAR utilizes a voluntary registration system based on guidelines, while China has its own medical devices law.
Currently, there is no common definition of the term medical device in these countries, which leads to the fact that certain products may be subject to medical devices law in some countries, but not in others. Products for veterinary use, for example, have to fulfil national medical device requirements in Thailand and the Philippines at the moment, but not in any of the other countries.
Classification will also often follow specific national rules. The requirements for registration differ widely with mandatory registration for all classes of devices and licensing requirements for manufacturers, importers and distributors in some countries, while in other countries, there are no requirements at all due to the lack of relevant legislation or administrative guidelines. The standard of adverse event reporting also varies and does not always form a part of the existing regulations.
Therefore, it is the explicit aim of the ASEAN member countries to develop and harmonise regulatory control of medical devices in all its member countries with the introduction of the ASEAN medical device directive (AMDD). The AMDD will introduce a common set of rules in all member countries and is mainly based on the recommendations of the Global Harmonisation Task Force (GHTF), a voluntary international group of medical device regulatory authorities and medical device trade associations from the European Union, the United States of America, Canada, Japan and Australia. The ASEAN member countries will be required to pass national laws implementing the AMDD over the next years. Singapore is the first country to finalize this process in 2011, but the other countries will follow on their own time depending mainly on the resources available at the national level.
Hong Kong SAR also relies on the GHTF guidelines for its own national regulations: The GHTF recommendations were completely transposed into the administrative guidelines, building a voluntary registration system. However, there is currently no defined point in time, when the change from voluntary to mandatory registration will take place. In contrast to this, China has developed its own medical device legislation independently from GHTF recommendations and is still in the process of further developing some aspects, like for example adverse event reporting, special requirements for IVD medical devices or GMP for medical devices.
A complete harmonisation of requirements for medical devices for the whole region is not to be expected in the near future, but major steps are already being taken in that direction. Until this goal is accomplished, companies intending to market products, which are considered to be medical devices in Europe, in these countries, have to verify for every single country, if and what specific requirements have to be met.
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