Bureau of Health Devices and Technology

BHDT DIVISIONS

Radiation Regulation Division

  • Formulates and enforces policies, standards, regulations and guidelines on the production, import, export, sale, labeling, promotion, distribution, servicing and use of ionizing and non-ionizing radiation device in medicine, dentistry, veterinary medicine, commerce and industry, education and training, research, anti-crime and household activities;
  • Undertakes radiation protection survey and evaluation of radiation facilities and the activities, thereat;
  • Issues licenses, permits, registration and accreditation certificates for radiation facilities, devices and technology and device production, sale, servicing and distribution facilities;
  • Provides technical assistance related to the radiation component of the national radiological emergency preparedness and response plan;
  • Provides consultative and advisory services to stakeholders and provides technical assistance in supervision and develops capability of DOH field offices in implementation and enforcement of laws, rules and regulations pertaining to radiation facilities, devices and technology;
  • Conducts health technology assessment, studies and researches on radiation devices and technology.

Medical Physics, Radiation Dosimetry and Testing Laboratory Division

  • Formulates and enforces policies, standards, regulation and guidelines on the accreditation of testing laboratories;
  • Conducts inspection of testing laboratories;
  • Issues accreditation certificates for testing laboratories
  • Undertakes testing and calibration of radiation measuring equipment, radiation devices, medical devices and other health related devices;
  • Provides technical assistance in medical physics and radiation dosimetry;
  • Operates and maintains the Secondary Standard Dosimetry Laboratory;
  • Provides radiation dosimetry and decontamination services during nuclear or radiological emergencies;
  • Conducts training courses in radiation dosimetry, radiation protection, quality assurance and related topics for radiation workers; and
  • Conducts studies and researches in medical physics, radiation doimetry and device testing.

Downloads:

Conformance Test Requirements
2. CT Conformance Test Protocols
3. Mammo Conformance Test Protocols
4. RF Conformance Test Protocols

Medical Non-radiation Device Regulation Division

  • Formulates and enforces policies, standards, regulation and guidelines on the production, import, export, sale, labeling, promotion, distribution, servicing and use of medical non-radiation devices and technology;
  • Conducts inspection of production and storage facilities of medical non-radiation devices;
  • Issues licenses, permits, registration and accreditation certificates for medical non-radiation devices, technology and device production, sale, servicing and distribution facilities;
  • Provides consultative and advisory services to stakeholders and provides technical assistance and supervision, to and develops capability of DOH field offices in implementation and enforcement of laws, rule and regulation pertaining to medical non-radiation devices, technology and device production facilities; and
  • Conducts health technology assessments, studies and researches on medical non-radiation devices and technology

Health-related Device Regulation Division

  • Formulates and enforces policies, standards, regulation and guidelines on the production, import, export, sale, labeling, promotion, distribution and use on non-medical and non-radiation health-related devices and technology;
  • Conducts inspection of production and storage facilities on non-medical and non-radiation health-related devices and technology;
  • Issues licenses, permits, registration and accreditation certificates for non-medical and non-radiation health-related devices, technology and device production facilities;
  • Provides technical assistance and supervision, consultative and advisory services to and develops capability of filed offices on implementation and enforcement of laws, rules and regulation pertaining to non-medical and non-radiation health-related devices, technology and device production facilities; and
  • Conducts health technology assessments, studies and researches on non-medical and non-radiation health-related devices and technology .