Health4Us
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Global regulations and standardization process
The international standards and accreditation for medical supplies is highly recommended in many countries emphasizing on human safety. The well-recognized FDA set out mandatory policy to support and filter medicinal and medical products/services, which relates to local food and drug laws and regulations. The global medical accreditations and standards are CE marks, ISO13485, EN6061 (as a part of ISO 13485) etc. Each includes high complex procedures, obligations and documentation traceability. For example, Canadian’s Food and Drug Administration and Health care mandates that such medicinal and medical products shall be officially enforced and accredited by ISO13485, EN6061 (as a part of ISO 13485), and CE Mark. In this case, the producer must comply to each standards starting from the actions of manufacturing, testing, documentation, and so on. Once the certification is granted to producer, the producer also complies to local standards as well as quarterly traceability. This means that the producer must process and comply each standard procedure which has high complexity and time spending, so that they possibly lose the market opportunities. These are barriers for Thai innovators to scale up their innovation in global scale.
Reference: http://www.canadian-healthcare.org
Thailand’s regulations and standardization
The market observations from medical products market indicated that the total medical supplies market in Thailand valued US$ 1,227 million in 2015 and 90 percent of market value stands for medical supplies. This could be explained that the market trends of medical supplies tended to increase significantly in future periods. The large volume of imported medical supplies in Thailand implied that the local medical standard and accreditation procedure authorized by Food and Drug Administration (Aor. Yor.), is easier than other regions, possibly to support health care demand in the country. According to Thailand’s context, Food and Drug Administration has solely rights to legalizing and enabling foreign medical supplies. In Thailand, it takes only Aor. Yor. standardization to allow producer and/or distributor legally enter into the market. Traceability per problem case includes in the regulations. The producers and/ or distributor must comply to the laws and regulations as specified in the Act of Food and Drugs B.E. 2546. Focusing on standardization process, the procedures of permitting medical products in Thailand described as follows:
The challenge for Thailand’s medical innovation still exists. Today, medical equipment and pharmaceutical products in some countries such as bandage, rubber glove, disposable equipment, stainless steel equipment etc. imported from Thailand. Thailand has competitors in Asia region as well as in the imported countries itself. In this case, there are gaps leading to opportunity for medical supplies innovations to be exported to the potential countries. The opportunity could leads as partnership in order to innovate new product for involved countries.
The Measurement
We could measure the different gap between the numbers of medical supplies that pass both international and local standards and the numbers of medical supplies that pass only local standards. The measurement metrics can be described as follows:
However, Thailand is lacked behind in healthcare innovation; thus, there is no detailed analysis and research in this measurement and how to improve the situation.
