Philippines
Medical Device Registration
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EMAIL: Philippines@asiaactual.com
Medical Device Registration in the Philippines
Government Authority
Medical Device regulations in the Philippines are administered by the Center for Device Regulation, Radiation Health and Research (CDRRHR) within the Department of Health. With efforts to harmonize the Philippine Regulatory Guidelines in accordance with the ASEAN Medical Devices Directive, the Philippines Department of Health recently released Administrative Order 2018-0002. The Administrative Order introduces risk classification of medical devices, as well as new requirements for initial device registration and renewal.
Medical Device Status
Instruments, machines, in vitro reagents, software and similar or related articles that make therapeutic or medical claims are considered Medical Devices in the Philippines.
Product Classification
The current product classifications are harmonized according to the ASEAN Medical Devices Directive with four classes A, B, C and D ranked from low to high risk categorization. The new review time and registration fees vary by risk categorization:
| Classification Type | Risk Level | Review Time | Application Fee |
|---|---|---|---|
| Class A Notification (CMDN) | Low | 4 to 12 weeks for authentication | PhP 7,500 |
| Class B Registration (CMDR) | Low-moderate | Within 180 days | PhP 7,500 |
| Class C Registration (CMDR) | Moderate-high | Within 180 days | PhP 7,500 |
| Class D Registration (CMDR) | High | Within 180 days | PhP 7,500 |
IVDs are not included in this classification. A separate Administrative Order is set to be issued regarding IVDs.
Please click the following links for more information on classifying and grouping medical devices in the Philippines.
Device Conformity Assessment
New regulations implemented on April 1, 2019 require risk Class A medical devices obtain a Certificate of Medical Device Notification (CMDN), and risk Class B, C and D medical devices obtain a Certificate of Medical Device Registration (CMDR) to in order to be imported and placed on the market in the Philippines. The new regulations will be implemented in phases:
- Currently all Class A medical devices must have a CMDN, and all Notified (those listed in Circular No. 2021-001-A) Class B, C and D medical devices must have a CMDR.
- All non-Notified (those not listed in Circular No. 2021-001-A) Class B, C and D medical devices must have an initial CMDN in place by September 30, 2024, then upon renewal a more involved CMDR will be required (Circular No. 2024-003).
- NOTE: Originally, the deadline for non-Notified medical devices was April 1, 2022 but the Philippines FDA has issued an extension to the grace period until 2024. See here for more information.
Home country approval, or reference country approval is required for all classes of devices.
Bordeline Products & Product Confirmation
Manufacturers unsure of their product’s classification and/or product category can request official feedback from the PFDA for a fee of PHP 550.
The PFDA will expect to see the following documents as part of their review:
- Letter of Intent
- Complete Technical Profile of the Product and must include the following:
- Description;
- Formulation/List of ingredients with corresponding amount per unit dose, expressed in the metric system;
- Indications;
- Directions for use;
- Claims (if any); and
- Labeling materials/Brochure.
- Classification of the product in the country of origin
- List of countries where the product is currently marketed and the corresponding classification of the product in these countries
- Representative sample
- Proof of payment + LRF (₱ 550.00)
Reference Countries
Australia – Canada – European Union – Japan – United States
In addition to Home/Reference Country Approval, Notifications and Registrations require technical documentation in accordance with the CSDT Template. Notifications require a device description, Certificate of Conformity, Declaration of Conformity, Declaration of Shelf Life and clear, complete, colored pictures of the labeling. Registrations require additional documentation such as risk assessments and clinical evidence.
Quality Systems Conformity Assessment
Class A, B, C and D devices all require ISO 13485 or an audit report from the FDA or Japanese PMDA to certify the quality system of the legal and/or actual manufacturing facilities.
Good Distribution Practice of Medical Devices (GDPMD) is not currently required in the Philippines but we expect it to become a requirement in the near future.
Regulatory Efficiency
Medical device registration in the Philippines is fairly straightforward and efficient.
Expedited Review Options
As of September 2022, the Philippines FDA is only providing expedited approval for applications submitted with CSDT documents used for applications submitted and approved in other ASEAN markets. This new process aims to shorten the review time to 30 business days. To learn more about this, please see our blog on the topic here.
Exceptions to Home Country Approval Requirement
Medical devices used strictly for research, clinical trial, exhibit and/or donated new are exempt from Notification and Registration. Researchers and institutions using exempt devices must apply for a Certificate of Medical Device Listing.
Validity and Renewal
CMDNs and CMDRs are valid for 5 years, and must be renewed every five years after the initial approval. Renewals can be filed 90 days prior to the expiry of the CMDR or CMDN.
Certificates of Product Registration (CPR) issued under the old rules will remain valid until expiry, at which point a license renewal application will generate a fresh CMDN, valid for 5 years with a fee of PhP 5,150 (US $110). Certificates of Exemption (COE) issued under the old rules will remain valid until November 3, 2021, or two years after issuance (whichever is shorter). To learn more of License Maintenance in the Philippines, click here.
License Transfer
For CMDN/CMDR transfer projects, Asia Actual will request to review a copy of the existing license and the supporting Foreign Agency Agreement. The transfer application requires the original Registration certificate. Asia Actual will assist to obtain this document from the current holder in the Philippines. However, if the current holder does not cooperate, then a full registration process will be required. The license transfer process typically takes 2 to 3 months to process.
Documents required for the transfer include:
- Letter of Request
- Termination of Contract / Deed of Assignment
- CMDN/CDMR (original)
- Complete Labeling set
- Foreign Agency Agreement
- ISO 13485 certificate
License Holder Requirements
The License Holder must be involved in the customs clearance process for devices for which it holds the Import License. Competitively bid third-party services (e.g., freight forwarding) are charged on a pass-through basis. A Shipment Report is generated per event to record fees and document receipts. The License to Operate of the importer, distributor or manufacturer must be up-dated with the foreign manufacturing source data.
Benefits of Using Asia Actual as Your Independent License Holder
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual for assistance with your medical device registration in the Philippines or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, bi-lingual consultants in the Philippines to manage the application, importing, and post-market surveillance needs.
Charmaine Roson Principal Consultant, Asia Actual Philippines
Charmaine’s Regulatory Hint
“During this transitory time through 2023, it can be difficult to understand what requirements are currently being applied. We can help.”
Latest Market Updates
Philippines Incentivizes Local Medical Device ManufacturingAugust 22, 2024 - 8:44 am
Philippines Issues Guidance on Medical Device LabelingMay 7, 2024 - 10:53 am
Philippines Incentivizing Local Medical Device ManufacturingMarch 19, 2024 - 11:44 am
Philippines FDA Announces New Fee Schedule for Medical DevicesDecember 15, 2023 - 10:14 am
Philippines FDA Extends CMDN Deadline to 2024March 31, 2023 - 4:34 pm
Medical Devices Required to be Registered Prior to Sale, Distribution and Use
See the full FDA Circular here.
1. Abdominal Pad
2. Absorbable Hemostatic Agents
3. Abutment
4. Access/injection port
5. Acetabular
6. Adhesive, all types
7. Administration Set, all types
8. Adoptor/Connector (all types)
9. Alcohol Swab
10. Anchor, Preformed
11. Anesthesia Set
12. Apheresis Kit
13. Artificial Saliva
14. Atopiclair Cream/Non-steroidal Cream
15. Bandage
16. Base Paste
17. Biopsy Needle/instrument
18. Blade, all types
19. Blood Bag
20. Blood Collection Tube/Kit; Blood Sampling Tube/Kit
21. Blood Transfusion Set
22. Blunt
23. Bone Marrow Collection/transfusion Kit
24. Bone Wax
25. Breathing Circuit
26. Burette
27. Burr, Dental/Surgical/Orthopeadic
28. Cannula, all types
29. Cap (disinfection, seal, taper, dead-end)
30. Cardiotomy Reservoir
31. Catheter, all types
32. Cavity Liner
33. Cell Regeneration Kit
34. Cell Separation Kit
35. Cement, Dental/Bone
36. Central Venous Blood Pressure Kit
37. Cervical Collar
38. Cervix Set
39. Chest Drainage Kit
40. Calve
41. Clinical Thermometer, all types except mercurial
42. Clip/Clip Applier
43. Closure Device; Skin Stapler (including remover)
44. Collagen
45. Condom
46. Conical Ring Segment
47. Contact lens solution
48. Contact Lens, including cosmetic contact lenses
49. Corset Cast
50. Cotton
51. Cytology Brush
52. Delivery System
53. Dental Bone
54. Dental Implants, Dental Restorative Material/Filler/Agent/Tooth Bonding/Etching/Varnish
55. Dental Suspension
56. Dialysate Concentrate for Hemodialysis
57. Dialyzer
58. Diamond Disc
59. Dilatation Device
60. Disinfectant of Medical Devices
60. Disinfectant of Medical Devices
61. Dissector
62. Drainage Pouche
63. Drape, Sterile
64. Dressing
65. Drill, Bone/Surgical
66. Drug Delivery Embolization System
67. Duodenal Tube
68. Ear Wax Remover
69. Earpiercing Device
70. Ecodrop – Inject
71. Electrode needle/pencil (electrosurgical)
72. Embolic Protective Device/System
73. Endoscopic Harvesting System
74. Endotracheal Tube
75. Epidural Probe
76. Evacuator
77. Extension Set/Kit
78. Feeding Set
79. Filler
80. Filter
81. Filtration Device
82. Flowmeter, blood cardiovascular
83. Former Compact
84. Gastric Band
85. Gauze
86. Gingiva Former
87. Gloves (surgical, examining, sterile, non-sterile)
88. Graft, bone/skin/vascular/biological
89. Guidewire, guide catheter
90. Heart Valve
91. Heart Valve/Annuloplasty Ring
92. Hemoconcentrator
93. Implantable Defibrillator
94. Implantable hearing device
95. Implantable Lead
96. Implantable Pacemakers
97. Implantable Prosthesis
98. Impression Material
99. Inflation Device
100. Infusion Fluid Thermal Warmer
101. Infusion System
102. Injectors
103. Intraocular Lens
104. Introducer Kit
105. IUD
106. IV Container
107. Knife, all types, sterile
108. Knot Pusher
109. Lancet
110. Laryngeal mask
111. Ligating Clip
112. Light Shield
113. Lubricating Gel/Jelly
114. Luer lock
115. Lumbar Puncture Tray
116. Manual Resuscitator with Mask
117. Mask (facemask, full mask, anesthesia, oxygen)
118. Moisture/Lubricating Eyedrop
119. Nasal Spray
120. Nasopharyngeal Airway
121. Nebulizing Kit with mask
122. Needle (all types) except for tattoo and acupuncture
123. Neurovascular Remodelling Device
124. Neurovascular/Endovascular Coil
125. Ophthalmic Drop/Solution
126. Ophthalmic Viscoelastic Device
127. Orthopeadic Implants (all kinds)
128. Orthopeadic Wire
129. Peak Flowmeter
130. Percutaneous Retrieval Device
131. Plaster of Paris
132. Plaster, all types
133. Plastic Strip
134. Plumset
135. Reconstruction Kit/Device; Fixation Device
136. Renal Dilatation Set
137. Revascularization Device
138. Root Canal Sealing Material
139. Rotahaler
140. Scalp Vein Infusion Set
141. Skin Retractor
142. Scrub, w/o drugs
143. Sealant
144. Self Adhering Wrap
145. Shunt System
146. Silicon Oil in Vial for Opthalmic Use
147. Skin Barrier for Ostomy Use
148. Skin Traction Set
149. Sodium Hyaluronate
150. Spinal Anesthesia Tray
151. Spine System
152. Stent
153. Sterilant for medical device
154. Stoma Adhesive Protective Powder/wafer
155. Stoma Bag
156. Stop-cock
157. Suction, Airway Kit
158. Surgical Mesh
159. Surgical Milk
160. Surgical Pack/Surgical Kit
161. Suture (with or without needle)
162. Suture Anchor
163. Synthetic Cast Padding
164. Syringe (with or without needle)
165. Tape, surgical/medical
166. Thrombectomy Set
167. Tissue Expander
168. Tissue Measuring Device
169. Tracheostomy Kit
170. Transfer Pack
171. Trocar System
172. Tube, all kinds that are connected to the patient or will be used to pass any type of fluids going into or from the patient’s body
173. Tulle Dressing (without drugs/medicine)
174. Umbilical Clamp
175. Urine Collecting Bag
176. Varnish, Cavity
177. Vascular Access System
178. Ventricular Probe
179. Wound Drainage Kit
180. All other implantable medical device (in parts or in system)