The Bureau of Health Devices and Technology (BHDT) develops plans, policies, national objectives, programs, projects and strategies for regulating health technologies, medical and health devices, radiation devices and facilities and other health-related devices that may pose hazards to human health. It formulates and implements rules, regulations and standards for registration, licensing and accreditation. It also provides technical assistance, capability building and advisory services to DOH field offices on licensing and enforcement of laws, rules and regulations and monitors, evaluates and ensures compliance with these regulations. Technical assistance is also provided to end-users of such devices as radiation emitting equipment. It monitors, evaluates and ensures compliance of users, manufacturers, distributors, advertisers and retailers of medical devices.
- Develops plans, policies, programs and strategies for regulating health and health-related devices and technology.
- Formulates rules, regulations and standards for licensing and accrediation of health and health-related devices and technology. ○ Conducts licensing and accreditation of health and health-related devices and technology.
- Provides technical consultative and advisory services to and develops capability of field offices on licensing and enforcement of laws, rules and regulations pertaining to health and health-related devices and technology.
- Monitors, evaluates and ensures compliance of manufacturers, distributors, advertisers and retailers of health and health-related devices and technology to health rules and regulations and standards of quality.
- Advises the Secretary and the Undersecretary of Health on matters pertaining to regulation of health and health-related devices and technology.
Target Population/Clients: All the people in the Philippines.
Area of Coverage: Nationwide
Mandate: PD 480, PD 1372, EO 119 and EO 102
Key Results Areas (KRAs)
- Radiation device and rational facility regulation
- Non-radiation device regulation
- Health technology assessment
- Capability building in terms of personnel recruitment/ training, BHDT facility improvement and procurement of equipment/test instruments
- Accreditation of testing laboratories
- Decentralization of enforcement functions to DOH Centers for Health Development (Regional Health Offices)
- Harmonization of BHDT standards with regional/ international standards
- Legislation to address gaps and overlaps
- Police power for stronger enforcement of law
- Human resource development
- Physical plant improvement
- Procurement of equipment/instruments
- Legal/administrative/regulatory structure
- BHDT Citizen's Charter
- Issuance of License to Operate (LTO) an X-ray Facility (Initial/Renewal)
- Issuance of Certifcate for Water Purification Devices/Systems
- Flowchart - Certificate of Product Registration
- Flowchart - License to Operate Medical Device Establishment
- Checklist of Requirements
- Automatic Renewal of Certificate of Product Registration of a Medical Device
- Opening an Establishment as Medical Device Importer/Wholesaler/Exporter
- Certificate of Product Registration of Medical Devices
- Registration of an Invitro Diagnostic Devices
- Opening and Establishment as Medical Device Manufacturer/Trader/Re-packer
- Renewal of LTO - Medical Device Importer//ExporterWholesaler/Manufacturer/ Re-packerBHDT Citizen's Charter