GOALS

Short-term

• To immediately enhance/consolidate the system of developing effective and credible regulators;
• To operationalize effective and relevant policies, standards, procedures and guidelines for Health Devices and Technology Regulation

Medium-term

• To ensure availability of reliable testing equipment by 2004;
• To develop effective and relevant policies, standards, procedures and guidelines for Health Devices and Technology Regulation;
• To update procedures and guidelines for Health Devices and Technology Regulation

Long-term

• To institutionalize a national system of regulating health devices and technology

Objectives:

Short -term

By end of 2001

• Generic Policies on Regulation of Health Devices issued and effectively managed;
• Effectively managed program on health devices and technology;
• 100% of standards on regulation of selected radiation devices issued effectively implemented and internationally recognized;
• 100% of requests for technical consultative and advisory assistance are responded to within 15 days upon receipt of request;
• Standards for accreditation of device testing laboratory issued and effectively followed; and
• 100% of complying suppliers of hospital equipment who apply for accreditation as DOH suppliers are accredited.

By end of 2002

• 5% of standards on regulation of hazardous medical non-radiation devices issued and effectively managed;
• 25% of standards on regulation of hazardous health-related devices issued and effectively managed;
• 100% of complying local manufacturers, importers, operators and distributors issued appropriate license;
• 100% complying testing laboratories are accredited by BHDT; and
• The BHDT Law is signed by the President of the Philippines.

Medium-termBy end of 2004, 100% of devices, complying with issued standards are registered

• Long-term
• By end of 2010, 25% of identified new technologies evaluated and validated.