A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 12th Year of Publication
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Cover Story

Healthcare Challenges In Indochina

Need for enhanced healthcare services

Vietnam, Cambodia and Laos share some similar healthcare situations. These include the need for improve occupational health and food safety practices. Better public education and surveillance will help to control food-borne diseases and to enhance healthcare services which can tackle specific problems of the ageing population at the grassroots level. Measures are also needed to keep check on non-communicable diseases, including dental and mental health services.

Need for more medical products and equipment

The bulk of medical products and equipment in these countries is purchased by government hospitals, clinics and healthcare centres. Expenditure on health items is expected to increase over the next few years to develop the physical, infrastructure of healthcare systems and spread over urban, suburban and rural areas.
In recent years, the market for medical equipment in Vietnam has boomed with diversified products from leading manufacturers like GE, Siemens, Philip, Toshiba and Shimadzu. The government has expanded its healthcare budget as out-of-date medical facilities need to be replaced. Some of these requirements include:

  • Medical imaging equipment such as CT scanners, X-ray machines, ultra-sound equipment and angiographs

  • Operating theatre equipment such as surgical instruments, anaesthesia administering machines and disposable medical instruments

  • Intensive care and monitoring equipment

  • Equipment for treating cardiac and asthmatic conditions e.g. respirators and blood oxygen measuring machines

  • Diagnostic and laboratory equipment

Local production of healthcare products is limited to items such as hospital furniture, simple operation tools and disposable syringes. The importation climate in Vietnam is open, without quota and specific shipment license imposed on imported equipment, although some items would still require registration and approval from the Ministry of Health.

Registration Of Medical Devices In Thailand
(source: Thai Medical Device Suppliers Association)

Medical devices vary widely in their complexity and their degree of risk and benefits. They do not all need the same degree of regulation. Thus, the Thai FDA places all medical devices into one of three registration levels based on level of control necessary to protect Thai-consumers to get good products in terms of quality, safety, and effectiveness.

These three registration levels are:

Level I: ‘Under General Control’

Level I devices are subject to the least regulatory control, which requires a Free Sales Certificate issued by the Health Authority (or a related government body) in the country of origin of the product.

THAIMED is officially authorized by the Thai FDA to arrange pre-screening and verification of Free Sales Certificates (FSC) for general medical devices (Level I).

While such screening will continue to be undertaken by the FDA, THAIMED will do the pre-screening and obtain approval of the FSC within 3 days, provided documents are in accordance with the requirements of the Thai FDA.

The certificate should be issued by a responsible Ministry/Government Department in the [foreign] country of origin. However, FSCs may no longer be issued by the manufacturer or by a Chamber of Commerce and endorsed by a Government department. Only FSCs issued in English are acceptable. Furthermore, if the official seal on the certificate is not English, the words contained therein must either be translated onto the original document or a translation, typed on the manufacturer’s stationary and signed & certified ‘true and correct’ by an authorized company executive stating his position/title, should be attached.

According to the registration requirements, illustrated catalogues, brochures, or leaflets detailing each product and clearly showing its model/type and dimensions must be included when the FSC is submitted to the Thai FDA for approval.

The FSC provided must be an original document and, once approved by the Thai FDA, will be valid for 5 years.

The Thai FDA has accepted the EC Certificate prescribing its compliance with the EU Directive, IMDD 90/385/EEC and MDD 93/42/EEC, in lieu of a Free Sales Certificate (FSC) for medical devices in the country that incorporated the MDD 93/42/EEC into national law. THAIMED has a guideline to submit the EC Certificate in lieu of a FSC. Please contact Ms. Mallika of THAIMED for more specific information.

Level II: Detailed report to the Secretary-General of the Thai FDA

Level II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurance. Level II devices may include special labeling requirements, mandatory performance standards and post-market surveillance.

Examples of Class II devices are: Physical Therapy Devices, Alcohol Analyzers, Silicone Breast Implants.

Level III: Pre-marketing Approval (Granting of a License/ Registration Certificate)

Level III is the most stringent regulatory category for devices. Level III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury

Pre-marketing approval is required, following a process of scientific review to ensure the safety and effectiveness of Level III devices. All level 3 devices require pre-marketing approval before they can be imported and marketed.

Examples of Class III devices are: Condoms, Examination Rubber Gloves, Surgical Rubber Gloves, Sterile Hypodermic Syringes for Single-use, Sterile Single-use Syringes for Insulin, HIV Test Kits.

(Ref : http://www.thailandrx.com/registermd.html )

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