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【技术产业】亚洲中小国家医疗器械市场注册信
Some Often-Overlooked Markets Are Ripe for Device Opportunities, But Manufacturers Must Keep in Mind Certain Regulatory Issues
Ames Gross and Momoko Hirose, Pacific Bridge Medical
When medical companies think of bringing their products to Asian markets, they typically think of larger countries such as China, Japan or Korea. However, other smaller Asian countries, such as Singapore and Malaysia, can be worthwhile destinations as well. Even Hong Kong, which is part of China, has a separate healthcare system and generally is considered its own market. Although they have smaller populations, these markets all have well-developed healthcare systems and are receptive to advanced products. In addition, their medical device markets are growing rapidly and, in many instances, are more easily accessible to foreign manufacturers. Before venturing into these territories, however, regulatory professionals will need to keep track of current changes in regulations to be successful. This article discusses recent regulatory developments in Singapore, Malaysia, Hong Kong, the Philippines and Taiwan.
Singapore
The Singapore Parliament recently passed the Health Products Bill, which regulates all health products. It seeks to regulate the manufacture, import, supply, presentation and advertisement of medical products and active ingredients used in the manufacture of medical products.
Singapore previously had voluntary registration for medical devices, but this new bill requires registration and licenses for the manufacture, import and supply of all medical products. Manufacturers would need a manufacturing license in addition to product registration, while importers would need to apply for an importer’s license and product registration. Wholesalers must hold a valid wholesaler’s license and can supply registered medical products only.
Previous registration of a health product would be valid as long as the registrant continues to pay the appropriate retention fees to the government and the registration is otherwise not suspended or cancelled.
The new bill also regulates medical product advertising, with penalties for false or misleading claims. Manufacturers, importers, suppliers or registrants of medical products must report any defects or adverse events related to their product. Other safety measures and quality assurances include holding importers, manufacturers and wholesalers accountable for the import or sale of medical products that are counterfeit, tampered with, unwholesome or adulterated.
The Health Sciences Authority (HSA) is the main regulatory body responsible for the administration and enforcement of this bill. The HSA will keep records and maintain a register of licensees and all registered health products.
Singapore also has focused on developing its medical device sourcing market. As a number of Singapore-based companies move into medical device production, government agencies are identifying the sector as a key growth area. Products that local companies have recently moved into include airway devices, infusion pumps and gas detection equipment. These companies are seeking to establish OEM relationships with existing Western medical device firms.
Singapore’s trade promotion agency, International Enterprise Singapore (IES), believes local enterprise has advantages over other locations in quality control, intellectual property protection and engineering talent. To help encourage and facilitate sourcing relationships, IES has organized a number of trips between Europe and Singapore to bring together local and Western firms. Also, IES, the Singapore Economic Development Board as well as the Standards, Productivity and Innovation Board have created the Medtech Local Supplier Group, which facilitated a number of supply agreements last year.
Malaysia
Since January 2006, Malaysia has had a voluntary registration system for medical devices and their manufacturers. As in Singapore, this has been intended to pave the way for a mandatory system by familiarizing the industry with some of its future requirements.
In August 2007, the Ministry of Health circulated a draft for comments outlining a mandatory medical device regulatory system. Although this draft contains few specifics, it appears that regulators have planned for the system to generally be based on global standards from the beginning. The draft frequently refers to Global Harmonization Task Force (GHTF) documents.
According to the draft, the new regulations will cover all stages of bringing medical devices to market, including design and development, clinical trials, manufacture, distribution, advertising, adverse event monitoring, use and maintenance as well as disposal. For products to receive marketing approval, the manufacturer may submit regulatory approvals from the US FDA, European Union, Australia, Canada or Japan, or from conformity assessment bodies. As in other major countries, low-risk devices simply may be notified to the government instead of reviewed and approved. Foreign manufacturers also will need to retain local representatives to retain their registrations.
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作者:admin@医学,生命科学 2010-10-30 05:11
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