Scope of Application
- Applies to any person, firm, corporation, or entity, government or private, operating/maintaining dental laboratories including dental prosthetic laboratories.
Key Definitions
- Dental Laboratory: Establishment making, repairing, or altering oral prosthodontic and orthodontic appliances for dentists.
- License: Formal DOH authorization to operate a dental laboratory.
- Prosthodontic Appliance: Devices replacing natural parts or correcting abnormalities (e.g., dentures, crowns).
- Orthodontic Appliance: Devices for treatment/prevention of teeth misalignment (e.g., braces, retainers).
Classification of Dental Laboratories
- Ownership: Private (funded and operated privately) or Government (operated by government units).
- Service Capability: Primary (basic dentures and crowns), Secondary (includes porcelain crowns/metal casting), Tertiary (integral parts manufacturing).
- Operation: General (all types per category) or Special (specialized prosthodontic work).
Technical Requirements
- Compliance with technical standards (Annex A).
- Adequate qualified personnel.
- Proper physical plant conditions (ventilation, lighting, cleanliness).
- Sufficient and appropriate equipment for safe, hygienic operation.
Procedural Guidelines
1. Documentary Requirements
- Initial license: notarized application forms, proof of dentist consultant's certification, business registrations, barangay clearance.
- Renewal: notarized renewal forms, original license, valid consultant certificates.
2. License Fees
- Fees required for initial and renewal applications, payable to DOH or CHD.
- Additional fees imposed for late renewal, license replacement.
3. Inspection
- Licensing team inspects compliance.
- BHFS/CHD may inspect anytime at reasonable hours.
- Notice of deficiency may be issued with 90 days compliance period.
- Non-compliance leads to cancellation.
4. Issuance and Validity
- Initial license issued after full compliance.
- Renewal applications filed 90 days before expiry; licenses valid until anniversary date.
Terms and Conditions
- License rights non-transferable.
- Transfer of laboratory location requires written notice and new license application.
- Changes in ownership/head must be reported within 15 days; unreported changes revoke license.
- License must be conspicuously displayed.
- Continuous operation allowed during renewal process unless ordered otherwise.
- License lapses after 60 days of non-renewal requiring new application and fees including arrears if operation continued without renewal.
Violations
- Operating without valid license.
- Changes in ownership, management, name, or location unreported within 15 days.
- False statements in application.
- Refusing inspection.
- Failure to correct deficiencies.
- Illegal dentistry by unqualified persons.
- Selling/displaying ready-made prosthetics for public use.
- Misleading signage.
Investigation of Complaints
- BHFS/CHD investigates complaints.
- Violation findings may result in suspension, revocation of license.
- Referral for criminal proceedings possible.
License Modification and Revocation
- Licenses subject to DOH rules and amendments.
- Suspended, revoked, or modified for false statements, violations, or failure to observe rules.
- Prior notice and investigation required except for willful/repeated violation or public safety concerns.
Appeal Process
- Appeal possible within 30 days to the Office of the Secretary.
- BHFS forwards records for review.
- Secretary's decision is final and executory.
Closure
- BHFS/CHD may order immediate closure of violating facilities.
- Enforce closure with assistance of appropriate agencies.
Penal Provisions
- Violators punished by imprisonment (1 month to 1 year), fine (P200 to P1,000), or both.
Implementing Mechanisms
- DOH-BHFS: Issues initial licenses except tertiary labs, provides technical assistance, monitors laboratories, publishes licensees.
- DOH-CHD: Issues license renewals except tertiary labs, provides assistance, monitors.
- Dental Laboratories: Maintain standard job records, keep prescriptions signed by dentists, make records available for inspection.
Repealing and Separability Clause
- Repeals inconsistent prior issuances.
- Invalid provisions do not affect remaining rules.
Effectivity
- Rules effective upon approval and publication in a newspaper of general circulation.