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SECTION 2. Authority - These rules and regulations are issued to implement Section 3 of Presidential Decree 1542 consistent with Department Circular No. 79, s. 1988 in line with E.O. 119, 5. 1987. (Reorganization of the Ministry of Health).
SECTION 3. Purpose - These rules and regulations are promulgated to protect the health of the public by ensuring quality service through licensure and regulation of the operation of dental prosthetic laboratories.
SECTION 4. Scope - The rules and regulations embodied herein shall apply to any person firm, corporation, or educational institution, or other entity, whether government or private, operating and maintaining dental prosthetic laboratories including the Armed Forces of the Philippines.
SECTION 5. Regulatory Authority - The Department of Health through the Bureau of Licensing and Regulation in the Office for Standards and Regulations, shall exercise the licensing and regulatory functions under these rules and regulations.
SECTION 6. Classification of Dental Prosthetic Laboratories –
6.1 For purposes of operation, Dental Prosthetic Laboratories may be classified, according to the type of services rendered, into 1) General Dental Prosthetic Laboratory and 2) Special Dental Prosthetic Laboratory.
General Dental Prosthetic Laboratory a laboratory that renders service for all types of prosthodontic work, such as complete acrylic crowns, fixed bridges, removable partial dentures, and metal crowns.
Special Dental Prosthetic Laboratory a laboratory that renders service through the dentist, for specialized prosthodontic work, such as porcelain crown and bridges, precision implant attachments, and orthodontic appliances.
6.2 For purposes of service capabilities rendered. Dental Prosthetic Laboratories are of three categories, namely (1) Primary, (2) Secondary, and (3) Tertiary, depending on the range of dental laboratory service capabilities offered and the presence of certain required manpower, equipment, and physical plant. The three categories are as follows:
Primary Category a laboratory equipped with all service capabilities needed to support its dental laboratory technician capable of doing basic acrylic work, complete dentures, fixed and/or removable dentures, orthodontic retainers, and plastic Jacket crowns.
Secondary Category a laboratory equipped with the service capabilities needed to support dental prosthetic laboratory technicians and dentists capable of doing all the services in the primary category plus porcelain jacket crowns and bridges, and metal casting.
Tertiary Category a laboratory equipped with the service capabilities needed to support the services of dental laboratory technicians and dentist in the primary and secondary categories plus manufacturing integral part or accessories in denture making; the owner of the laboratory may be an exporter and/or importer.
6.3 For purposes of classification according to Institutional Character, Training Dental Prosthetic Laboratories may be either:
1) Institutional Training Dental Prosthetic Laboratory, or
2) Non-Institutional Training Dental Prosthetic Laboratory
Institutional Training Dental Prosthetic Laboratory this laboratory is a unit in a recognized and accredited dental school.
Non-Institutional Training Dental Prosthetic Laboratory this laboratory is not a unit of any dental school, college or university.
SECTION 7. Registration and License –
7.1 License A license, within the meaning of these Rules and Regulations, is a formal authorization issued by the Bureau of Licensing and Regulation (BLR), upon approval of the Undersecretary of Health for Standards and Regulation, Department of Health to a person, firm or corporation and other entitles, to operate and maintain dental prosthetic laboratory whether government or private, of general or of special category, and be it institutional training in character or otherwise.
7.2 No government or private dental prosthetic laboratory shall operate or be opened to the public without being first registered in accordance with these Rules and Regulations, nor shall be allowed to operate and be maintained without a license to operate (LTO) issued by the BLR.
SECTION 8. Licensing Requirement (Technical Standards) –
8.1 All dental prosthetic laboratories shall be required to demonstrate compliance with the technical standards as a requirement to licensing.
8.1.1 Personnel - adequate staffing by qualified personnel with a licensed dentist and by trained non-professionals.
8.1.2 Physical Plant - well ventilated, lighted, clean and safe building sufficient to accommodate its activities.
8.1.3 Equipment and Apparatus - equipment and apparatus necesary to undertake the required services.
8.2 The BLR shall evaluate compliance with such technical standards in accordance with the minimum requirements for each category of dental prosthetic laboratories.
SECTION 9. Management of the Denial Prosthetic Laboratory - The head of the Dental Prosthetic Laboratory, whether training or non-training, should be a licensed dentist duly registered by the Board of Dentistry. This shall be mandatory for all such laboratories of secondary and tertiary category; provided, however in the case of laboratories of primary category, the dentist may only serve as a consultant.
SECTION 10. Training of Dental Laboratory Technicians - Within six months following the initial registration and licensing of a dental prosthetic laboratory, all dental laboratory technicians without a corresponding certificate of formal training who are employed in that laboratory shall undergo an accelerated training program either by completing the equivalent of one semester half-day training in a school for dental prosthetic laboratory technicians to be designated by the Director of BLR or by participating in an accelerated training program to be conducted for the purpose by the BLR.
SECTION 11. Records –
11.1 The standard record book shall reflect jobs ordered and finished. It shall be ready at all times for inspection. The original prescription or work authorization signed by the dentist shall be filed and maintained for a period of one (1) year.
SECTION 12. Inspection - Every dental prosthetic laboratory shall be inspected regularly, and its records shall be made available to determine compliance with the Rules and Regulations.
12.1 Each license shall allow the BLR or his duly authorized at reasonable hours to inspect, manner, the dental prosthetic the Director of representatives in a reasonable laboratory.
12.2 The Director of the Bureau of Licensing and Regulation or his representative may be assisted by experts from a professional organization/association in such inspection.
12.3 The Regional Health Directors and Provincial, City, and Municipal Health Officers are required to report the existence of any dental prosthetic laboratories operating without license or any violations of these Rules and Regulations to the BLR.
SECTION 13. Basic Registration and Licensing Requirement –
13.1 All dental prosthetic laboratories, both government and private, desiring to establish or operate and maintain a dental prosthetic laboratory shall submit to the BLR the following prescribed forms, duly accomplished by the owner/proprietor/manager.
13.1.1 Application for registration and issuance of license to operate dental prosthetic laboratory (BLR-DPL Form No. 3)
13.1.2 Petition (BLR-DPL Form No. 5-A)
13.1.3 Information Sheet (BLR-DPL Form No. 3-B)
13.1.4 Sworn Statement (BIR-DPL Form C)
13.2 Each petition shall be signed under oath or affirmation by the applicant or owner and will be subject for screening and approval.
13.3 Upon receipt of said application together with the registration fee, a dental licensing inspection team shall inspect within 60 days the establishment and variety if the applicant has complied with the requirements prescribed in these regulations.
13.4 Any false statement in the application or failure to comply with requirements may serve as basis for the Director of BLR to refuse the issuance of a license to operate dental prosthetic laboratory.
SECTION 14. License Fees –
14.1 Every government or private dental prosthetic laboratory desiring to operate for the first time or to resume operation after ceasing to operate for some period of time shall pay a non-refundable fee (for registration and license) in accordance with the schedules prescribed herein below:
14.2 No registered dental prosthetic laboratory shall commence or resume operation without a corresponding license to operate, which shall be issued upon payment of the license fee as prescribed in this section.
14.3 All fees shall be payable to the cashier of the Department of Health and/or Regional Health Offices in their respective areas of concern.
14.4 All dental prosthetic laboratories shall pay the fees in accordance with the following schedules:
For New Licenses: Registration Fee License Fees: Primary Secondary Tertiary For Renewal of Licenses: Primary Secondary Tertirary
14.5 A penalty of Three Hundred Pesos (P300.00) in addition to the renewal fee shall be paid if the application for renewal is filed after March 31 of each year.
14.6 Reconstitution Fee - One Hundred Pesos (P100.00) shall be charged for replacement of lost, worn-out, or laminated licenses.
SECTION 15. Issuance of Licenses -
15.1 The license will be issued upon approval of the Undersecretary of Health for Standards and Regulation, Department of Health, if the application is found to be meritorious and the license fees duly paid; otherwise the same shall not be approved.
15.2 Upon written appeal duly verified by the applicant or the license, in cases where issuance or renewal of license is denied by the Director of BLR, the Undersecretary of Health for Standards and Regulation or his duly authorized representative, shall hold administrative hearing to determine justifiability of the recommendation of the said Director. A certified copy of the recommendation sought to be reviewed shall be enclosed with the appeal.
SECTION 16. Terms and Conditions –
16.1 The license is granted on the basis of specific conditions and limitations in compliance with certain requirements as established during the inspection and defined in the issuance of the license.
16.2 The license as herein granted as well as any right under the license shall not be assigned or otherwise transferred directly or indirectly to an unauthorized party.
16.3 The owner or the owner’s representative of any dental prosthetic laboratory desiring to transfer the physical plant of a registered dental prosthetic laboratory to another place shall inform the Bureau of Licensing and Regulation in writing within 15 days after transfer has been completed. The laboratory at its new location shall be subject to reinspection and shall comply with the requirements including the technical standards, as prescribed herein.
16.4 Every dental prosthetic laboratory shall be issued a license and every branch thereof, maintained in separate premises, shall be issued a separate license, even though they are all operated under the same management.
16.5 Change of Ownership/Head - Any change in ownership or change of head of the dental prosthetic laboratory shall be reported within 15 days in writing by the person concerned to the Bureau of Licensing and Regulation for notation and approval. In cases where change in ownership of license is found to be meritorious, an application for a new license by the new owner shall be required. Failure to report the change of ownership will automatically revoke the license of the dental prosthetic laboratory.
SECTION 17. Exhibition of License to Operate Dental Prosthetic Laboratory and the Rules and Regulations - The license of the dental prosthetic laboratory must be placed in a conspicuous place within the laboratory. The dentist who heads the dental prosthetic laboratory must likewise display his/her certificate of proficiency in the specialty. A copy of these Rules and Regulation should be readily available for guidance of all the staff and personnel in the laboratory.
SECTION 18. Expiration - Every specific license issued shall be valid only for the year of issue and shall expire on the last day of December of the year stated therein.
SECTION 19. Renewal –
19.1 License to operate and maintain a dental prosthetic laboratory shall be renewed every year.
19.2 Application for renewal of license shall be filed during the first three (3) months of the current year.
19.3 The Bureau of Licensing and Regulation or the Regional Health Office concerned shall process applications for license renewal immediately upon receipt thereof subject to ocular inspection by the Inspection Team. Unless otherwise ordered by the Director of the Bureau of Licensing and Regulation or the Regional Health Office concerned, the dental prosthetic laboratory may continue operation during the pendency of the final action on its application, unless otherwise advised or ordered by the proper authorities to cease operation.
19.4 A license issued that has not been renewed within five (5) months after its expiry date shall considered lapsed and the registration shall be cancelled.
19.5 After the license of a dental prosthetic laboratory has lapsed, an application for registration and a new license to operate the same laboratory shall be required and the fees prescribed under Section 14.4 for new licenses shall be paid before such dental prosthetic laboratory can be allowed to operate again, provided that the owner/proprietor/manager had sent a notification in writing of its cessation of operation, and had surrendered its last license to operate to the BLR.
19.6 In cases, however, where the dental prosthetic laboratory concerned did not actually close its operation after its license had been considered lapsed, and also in cases where the said laboratory had actually ceased operation but its owner/proprietor/manager failed to give the corresponding notification of such cessation to operate, or failed to surrender its last license to operate, to the BLR, then the said laboratory applying for registration and new license shall also pay all arrears corresponding to the years that Its license had not been renewed.
19.7 For purposes of renewal of license, the following shall be submitted:
19.7.1 Application for renewal of license to operate (BLR-DPL Form) to be duly accomplished
19.7.2 Original license to operate dental prosthetic laboratory for revalidation.
19.7.3 Official Receipt of payment of renewal fee.
SECTION 20. Publication of list of licensed Dental Prosthetic Laboratories –
20.1 A list of licensed dental prosthetic laboratories according to their categories shall be published periodically and made available to any person, agency, or organization for legitimate purpose.
SECTION 21. Modification and Revocation of License –
21.1 The terms and conditions of each license shall be subject to these Rules and Regulations, and to all such amendments thereto as the Secretary of Health may deem necessary.
21.2 Any license may be revoked, suspended or modified in full or in part for any material false statement in the application as revealed by subsequent statement of the applicant or as shown by the record of inspection, or for a violation hereof, or for failure to observe any of the provisions of these Rules and Regulations.
21.3 Except in cases of willful, or repeated violation hereof, or where public health interest or safety requires otherwise, no license shall be modified, suspended, or revoked, unless prior notice has been made and corresponding investigation conducted.
SECTION 22. Violations -
22.1 The license to operate a dental prosthetic laboratory may be suspended or revoked by the Undersecretary of Health for Standards and Regulation upon violation of P.D. 1542 or the rules and regulations issued in pursuance thereof, including the commission of the following acts by the persons owning or operating a dental prosthetic laboratory or by persons under their authority:
1) Operating, managing or maintaining a dental prosthetic laboratory without a valid license to operate for the current year.
2) Change of ownership, management, name or location without informing the Bureau of Licensing and Regulation in writing within 15 days.
3) Any material false statement in the application.
4) Refusal to allow inspection of the dental prosthetic laboratory by persons authorized by the Director of the Bureau of Licensing and Regulation during reasonable hours.
5) Failure to make necessary correction of deficiencies required by the Bureau of Licensing and Regulation to comply with standards and requirements after due notice.
6) Any dental technicians/persons illegally practicing dentistry (e.g. actually taking impressions in the mouth of the patients) for the purpose of constructing dental prosthesis.
SECTION 23. Investigation of Charges of Complaints - Upon filing of a complaint or charges duly sworn to by a person, interested party, or corporation against a dental prosthetic laboratory or any of its personnel to the effect that one or more of such personnel of a licensed laboratory have violated or are violating P.D. 1542 or the provisions of these regulations, the Undersecretary of Health for Standards and Regulation or his duly authorized representative/s shall investigate the complaint or charges and verify if the laboratory concerned or any of its personnel is guilty of the charges. If upon investigation, a person or persons are found violating the provisions of P.D. 1542 or any of these regulations, the Undersecretary of Health for Standards and Regulation shall suspend for a definite or indefinite period of time or cancel or revoke the license of the laboratory and the authority of the offending person or persons, without prejudice to taking the case to judicial authorities for criminal action.
SECTION 24. Penal Provision - Any person who violates any provision of P.D. 1542 or the rules and regulations and standard requirements implementing the decree shall be punished by imprisonment of not less than one month but not more than one year or by a fine of not less than Two Hundred Pesos (P200.00) but not more than One Thousand Pesos (P1,000.00) or both such fine and imprisonment in the discretion of the court.
SECTION 25. Repealing and Separability Clauses - Any Administrative Orders, Rules and Regulations, and other Department issuances inconsistent herewith are hereby repealed, modified, or amended accordingly.
In the event that any section, paragraph, sentence, clause or word of this Order is declared invalid for any reason, the other provisions thereof shall not be affected thereby.
SECTION 26. Effectivity - These Rules and Regulations shall take effect upon approval and publication in a newspaper of general circulation and supersedes all administrative orders or other issuances inconsistent therewith.
Adopted: 17 Feb. 1992
(SGD.) ANTONIO O. PERIQUET, M.D.
Secretary of Health