Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

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2 DRAFT FOR REVIEW/COMMENT
3 FDA CIRCULAR
4 No. __________________
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7 SUBJECT: Guidelines on the Licensing of Retailers of Medical Devices in the
8 Philippines
9 ____________________________________________________________________________
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11 I. RATIONALE
12
13 Republic Act No. 9711, otherwise known as the “Food and Drug Administration
14 (FDA) Act of 2009”, mandated the FDA to develop policies, guidelines and standards on
15 the regulation of health products including medical devices to ensure the safety, quality
16 and efficacy of these products in the market. Furthermore, pursuant to the provisions of
17 the same law, a License to Operate (LTO) is required for establishments engaged in the
18 sale, offering for sale or retail of any medical device including in-vitro diagnostic device.
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20 In the absence of LTO, retailers of medical devices are not compelled to comply
21 with the government regulations covering the said health products, causing the
22 proliferation of unregistered medical devices in the market as evidenced by the numerous
23 issued FDA Advisories on unregistered or unnotified medical devices.
24
25 On 8 May 2020, Department of Health (DOH) Administrative Order (AO) No.
26 2020-0017 entitled “Revised Guidelines on the Unified Licensing Requirements and
27 Procedures of the Food and Drug Administration Repealing Administrative Order No.
28 2016-0003” was issued wherein retailers of medical devices are included in the list of
29 establishments that are required to secure a License to Operate from the FDA before
30 engaging in the manufacture, importation, exportation, sale, offering for sale,
31 distribution, transfer, non-consumer use, promotion, advertising or sponsorship activities
32 of health products.
33
34 Licensing of retailers of medical devices will ensure access of patient and the
35 general public to safe, quality and effective medical devices.
36
37 To provide specific guidelines supplementing the provisions of AO 2020-0017
38 on the licensing of retailers of medical devices, this Circular is hereby issued.
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40
41 II. OBJECTIVE
42
43 This Circular aims to:
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45 1. Specify the establishments classified as retailers of medical devices;
46 2. Clarify the licensing of drug outlets which are also retailers of medical devices

Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines

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Website: www.fda.gov.ph Email: info@fda.gov.ph
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1 3. Provide specific requirements for and responsibilities of qualified persons of

2 retailers of medical devices; and
3 4. Provide specific requirements for post-licensing inspection of retailers of medical
4 devices.
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6
7 III. SCOPE
8
9 These guidelines shall apply to the following retailers of medical devices:
10 1. Retail stores for medical devices;
11 2. Clinics that sell products classified as medical devices except those that are covered
12 by the DOH One Stop Shop Licensing System;
13 3. Sellers of online shopping website, social media platforms and/or TV shopping
14 companies that sell or offer to sell medical device directly to the general public
15 4. Operator of medical device vending machine
16 5. Optical shops
17 6. Drug outlets, such as drugstores, or boticas, and retail outlets for non-prescription
18 drugs (RONPD) that also sell or offer to sell medical devices
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20 In consonance with AO 2020-0017, this FDA Circular shall not cover grocery
21 stores, supermarkets, convenience stores, chandler, kiosks and other similar stores.
22 However, although these establishments are exempted from securing the LTO, they shall
23 be held liable and shall be considered violating the FDA regulations if they sell or offer
24 to sell unregistered/unnotified medical devices.
25
26 IV. DEFINITION OF TERMS
27
28 The terms used in this Circular shall have the meaning as defined in R.A. 9711 and its
29 implementing rules and regulations, Administrative Order (AO) No. 2020-0017 and
30 related laws and regulations. However, for clarity and for purposes of these guidelines,
31 the following terms are defined as follows:
32
33 1. Certificate of Medical Device Notification (CMDN) – refers to the authorization
34 issued for a medical device that complies with all the requirements for Notification of
35 a medical device. The CMDN is issued for medical devices that will fall under class
36 A.
37
38 2. Certificate of Medical Device Registration (CMDR) – refers to the authorization
39 issued for a medical device that complies with all the requirements for Registration
40 of a medical device.
41
42 3. Distributor/Importer/Exporter – refers to any establishment that imports or exports
43 raw materials, active ingredients and/or finished product for its own use or for
44 wholesale distribution to other establishments or outlets. If the
45 distributor/importer/exporter sells to the general public, it shall be considered a
46 retailer.
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1 4. Distributor/Wholesaler – refers to any establishment that procures raw material,

2 active ingredients and/or finished products from a local establishment for local
3 distribution on wholesale basis.
4
5 5. Medical Device – refers to any instrument, apparatus, implement, machine,
6 appliance, implant, in-vitro reagent or calibrator, software, material, or other similar
7 or related article intended by the manufacturer to be used alone, or in combination,
8 for human beings for one or more of the specific purpose(s) of diagnosis, prevention,
9 monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment,
10 alleviation of, or compensation for an injury; investigation, replacement,
11 modification, or support of the anatomy or of a physiological process; supporting or
12 sustaining life; preventing infection; control of conception; disinfection of medical
13 devices; and providing information for medical or diagnostic purposes by means of
14 in-vitro examination of specimens derived from the human body. This device does
15 not achieve its primary intended action in or on the human body by pharmacological,
16 immunological or metabolic means but which may be assisted in intended function
17 by such means.
18
19 6. Qualified Person – refers to an organic of full-time employee of the establishment
20 who possesses technical competence related to the establishment’s activities and
21 health products by virtue of his profession, training or experience. A qualified person
22 has the responsibility to comply with the technical requirements of the FDA or discuss
23 or clarify matters with the FDA when submitting technical requirements or engage
24 the FDA officials when conducting inspection or post-market surveillance activities.
25 The qualified person may also be the duly Authorized Person of the establishment.
26
27 7. Prescription Medical Device – refers to a medical device that requires prescription
28 by a licensed professional in accordance with the law and pertinent rules and
29 regulations.
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31 8. Retailer – means any establishment which sells or offers to sell medical device
32 directly to the general public.
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34 V. GUIDELINES
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36 1. License to Operate
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38 a. As provided for in AO 2020-0017, all retailers identified in Section III shall
39 apply for a License to Operate (LTO) at the FDA.
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41 b. An FDA licensed drug retailer (drugstore, pharmacy, botica) or RONPD that
42 also sells or offers to sell any medical device product shall apply for a separate
43 LTO from FDA as a retailer of medical device.
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45 c. The LTO issued by the FDA shall be conspicuously displayed inside the
46 establishment.
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2 2. Qualified Person
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4 a. The qualification and credential requirements for qualified person for retailers
5 of medical device shall be the same as the requirements for manufacturers,
6 trader and distributor of medical devices as specified in AO 2020-0017.
7
8 b. For retailers of ophthalmic lenses, prisms, contact lenses and their accessories
9 and solutions, low vision aids, and similar appliances and devices wherein
10 dispensing is governed by R.A. 8050, “An Act Regulating the Practice of
11 Optometry, Upgrading Optometric Education, Integrating Optometrists, and
12 for Other Purposes”, the Qualified Person shall be an optometrist.
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14 3. Post-licensing Inspection
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16 All licensed retailers shall be subjected to routine or spot check inspection during
17 operating hours by authorized FDA personnel. The following documents shall be
18 verified during inspection:
19 a. Application form
20 b. Proof of business name registration
21 c. Business Permit if the establishment’s address is different from the business
22 name registration address
23 d. Credentials of qualified person such as:
24 i. Valid PRC ID for professions with Board/Licensure exam or Diploma
25 for profession without Board/Licensure exam
26 ii. Certificate of attendance to seminars, training, learning and development
27 activities on medical device safety, quality and use given by the academe,
28 industry,
29 e. Standard operating procedures that includes monitoring of quality of medical
30 device products and reflects observance of good distribution and storage
31 practices
32 f. Relevant reference materials (RA 9711, AO 2018-0002, FDA Circular No.
33 2020-001 and other related issuances on medical devices)
34 g. Valid LTO issued by the FDA
35 h. Copies of Certificate of Medical Device Notification/Certificate of Medical
36 Device Registration (as applicable) of medical devices being sold.
37 i. Risk management plan
38
39 4. Fees for licensing of retailers of medical devices shall be similar to fees for
40 licensing of drug outlets as per AO 50 s. 2001 which shall be as follows:
41 Initial: ₱2,000.00 valid for 2 years
42 Renewal: ₱3,000.00 valid for 3 years
43 Fee for variation of LTO: ₱500.00
44
45 An additional 1% thereof for the Legal Research Fee (LRF) shall be collected by
46 the FDA. The LRF imposition is pursuant to FDA Circular No. 2011-003 or the
47 “Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended
48 by PD 200 and further Amended by PD 1856”.
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1 5. All retailers of medical devices shall only sell or offer to sell medical devices with
2 appropriate authorization (Certificate of Medical Device Registration or Certificate
3 of Medical Device Notification) issued by the FDA, as applicable.
4
5 6. All retailers of prescription medical devices shall only sell such devices with a valid
6 prescription issued by an authorized professional in accordance with existing laws,
7 rules and regulations. For ophthalmic lenses, prisms, contact lenses and their
8 accessories and solutions, low vision aids, and similar appliances and devices,
9 ophthalmic prescription shall be required wherein such products shall only be
10 dispensed by a registered optometrist.
11
12 7. Online selling of prescription medical devices is prohibited. Retailers of
13 prescription medical devices may advertise these products online; however,
14 advertisement with link for online purchase of prescription medical device products
15 shall not be allowed.
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17 8. All retailers of medical devices shall immediately stop the sale of medical devices
18 which have been banned or withdrawn for health and safety issues in the country
19 of origin and those that are declared by FDA to be unregistered, counterfeit,
20 injurious, unsafe or dangerous.
21
22 9. FDA licensed manufacturers, traders or distributors (importers, exporters and/or
23 wholesalers) of medical devices that intends to sell medical devices directly to
24 general public shall apply for a minor variation (additional activity) of their existing
25 LTO. Requirements include submission of application form and payment of
26 corresponding fee.
27
28
29 VI. RESPONSIBILITIES OF THE QUALIFIED PERSON
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31 The qualified person of the establishment shall be responsible in assuring the safety,
32 quality and efficacy/performance of medical devices, which shall include the following:
33
34 1. Observance of good distribution and storage practices and other relevant and
35 applicable practices
36
37 2. Monitoring of inventory of products including expiry dates (if applicable)
38
39 3. Ensuring any adverse event experienced by patients/consumers are properly
40 handled, documented and reported to the establishment’s supplier/distributor.
41 Incident that caused or contributed to the death, serious illness or serious injury to a
42 consumer, a patient, or any person shall be reported to the Food and Drug
43 Administration through the Center for Device Regulation, Radiation Health and
44 Research.
45
46 4. Ensuring all medical device products offered for sale are with issued corresponding
47 authorization from FDA
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1 5. Ensuring compliance of the establishment with the existing FDA regulations and
2 advisories on medical devices.
3
4 6. Require appropriate authorization from the establishment’s supplier/distributor prior
5 to purchase and selling of the medical device
6
7 7. Keeping himself updated regarding the full implementation of AO 2018-0002 re:
8 Guidelines Governing the Issuance of an Authorization for a Medical Device based
9 on the ASEAN Harmonized Technical Requirements and/or its subsequent
10 amendment(s) and other FDA policies/issuances on the regulation of medical
11 devices in coordination with the establishment’s supplier/distributor.
12
13
14 VII. PENALTY CLAUSE
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16 Sanctions over violations of any of the provisions of this FDA circulars shall follow
17 the Rules of Administrative Procedure provided in the Implementing Rules and
18 Regulations of RA 9711.
19
20
21 VIII. SEPARABILITY CLAUSE
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23 In the event that any provision or part of this Circular is declared invalid, the other
24 provisions hereof shall not be affected.
25
26
27 IX. TRANSITORY PROVISION
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29 All existing retailers of medical devices prior to the issuance of this Circular shall
30 be given a period of two (2) years from the effectivity of this Circular to comply with the
31 provisions thereof.
32
33
34 X. EFFECTIVITY
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36 This Circular shall take effect fifteen (15) days after its publication in a newspaper
37 of general circulation and upon acknowledgement of receipt of a copy hereof by the
38 University of the Philippines - Office of the National Administrative Register.
39 .
40
41
42 ROLANDO ENRIQUE D. DOMINGO, MD
43 Director General
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47 DTN: 20200521130631
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17 To follow as a separate issuance (should cover distributor and retailers)
18
19 ANNEX A
20
21 GOOD DISTRIBUTION AND STORAGE PRACTICES FOR RETAILERS OF
22 MEDICAL DEVICES
23
24 A. RECORDS
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26 1. Records should be kept for each purchase and sale of medical device showing the
27 following details:
28 a. Date of purchase
29 b. Name of medical device
30 c. Model number (if applicable)
31 d. Batch/Lot number (if applicable)
32 e. Quantity received and sold
33 f. Name of supplier
34 2. Records should be kept for as long as the medical device product is registered with the
35 FDA.
36 3. Records should show traceability of the origin.
37 4. Proof of delivery transactions should be kept.
38 5. There should be an orderly and secure system of filing up to date invoices from suppliers
39 and buyer.
40 6. Records should be easily retrievable, stored and protected against unauthorized
41 modification, damage, and/or loss of documentation.
42 7. If the records are generated and kept in electronic form, there should be backups to prevent
43 any accidental data loss.
44
45 B. PERSONNEL
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47 1. Responsibility and Authority
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1 Establishment should have an organizational chart and documented job descriptions,

2 including key responsibilities and authorities.
3
4 2. Training and Competency
5
6 Key personnel in charge including those in the warehousing operations should possess
7 the necessary competence in terms of education, training, skills and experience.
8
9 C. PREMISES
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11 1. Cleanliness
12 a. Premises should be kept clean.
13 b. Frequency of cleaning of the premises should be recorded.
14 c. There should be no smoking, eating and drinking in areas where medical devices are
15 stored and handled.
16
17 2. Vermin Control
18 a. The storage area should be designed and equipped to prevent entry of vermin and
19 other animals into the area
20 b. There should be a vermin control program to prevent vermin infestation. Appropriate
21 records should be kept for this purpose.
22
23 D. RECEIPT, STORAGE, STOCK HANDLING AND DELIVERY TO CUSTOMERS
24
25 1. Receipt of stocks
26 a. The receiving area should be adequate and should have protection for deliveries from
27 from bad weather during unloading.
28 b. It should be separate from the storage area.
29 c. Each incoming delivery should be checked to ensure that the correct product is
30 delivered from the correct supplier. This may include checking of the purchase order,
31 containers, label description, batch number, expiry date, product and quantity.
32 d. The delivery should be examined for uniformity of the containers and, if necessary,
33 should be subdivided according to the supplier’s batch number should the delivery
34 comprise more than one batch.
35 e. Each container should be carefully checked for possible contamination, tampering and
36 damage. Any suspect containers or, if necessary, the entire delivery should be
37 quarantined for further investigation.
38 f. Medical devices subject to specific storage measures should be immediately identified
39 and stored in accordance with the specified instruction(s).
40 g. Measures should be taken to ensure that rejected medical devices cannot be used. They
41 should be segregated and securely stored while awaiting destruction or return to the
42 supplier.
43
44 2. Storage
45 a. Precautions should be taken to prevent unauthorized persons from entering storage
46 areas.

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1 b. Storage areas should be of sufficient capacity to allow the orderly storage of the
2 different categories of medical devices.
3 c. There should be adequate lighting and ventilation.
4 d. Storage areas should be maintained within acceptable and specified temperature limits.
5 The storage conditions for medical devices should be in accordance with their
6 labelling.
7 e. Where special storage conditions are required on the label (e.g. temperature, relative
8 humidity), these should be provided, controlled, monitored and recorded. Temperature
9 of the storage areas must be measured at suitable predetermined intervals to show the
10 maximum and minimum temperatures for the day and recorded. The equipment used
11 for monitoring should be calibrated and be suitable for their intended use.
12 f. Medical devices should be stored off the floor and suitably spaced to allow cleaning
13 and inspection. If pallets are used, such should be well maintained and kept clean at all
14 times.
15 g. Medical devices should be handled and stored in such a manner as to prevent
16 contamination, mix-ups and cross-contamination.
17 h. Appropriate and suitable storage conditions should be provided for hazardous,
18 sensitive and dangerous materials such as combustible liquids and solids, pressurized
19 gases, highly toxic and radioactive substances.
20 i. There should be designated areas for quarantined, saleable stock, expired,
21 rejected/damaged, recalled and returned medical devices. Such medical devices should
22 be properly labeled.
23 j. A list of medical devices should be maintained and the medical devices properly
24 identified.
25
26 3. Stock Control and Rotation
27 a. Periodic stock reconciliation should be performed at defined intervals by comparing
28 the actual and recorded stock. The root cause for stock discrepancies should be
29 identified and appropriate corrective and preventive action taken to prevent recurrence.
30 b. Stock should be appropriately rotated. The “first expired/first out” principle should be
31 followed. For cases where the medical devices do not have expiry dates, “first in/first
32 out” should be applied. If there is a manufacturing date, the product with the earlier
33 manufacturing date should be first to be out/released.
34 c. All stock should be checked regularly to identify obsolete and expired stock.
35 d. Medical devices with broken seals, damaged packaging or suspected
36 tampering/contamination must not be sold.
37 e. Medical devices bearing an expiry date must not be sold close to the expiry date such
38 that the expiry date is likely to occur before the consumer uses the medical devices.
39 Expired medical devices should not be sold to consumers.
40 f. All labels and containers of medical devices should not be altered, tampered or
41 changed.
42
43 4. Delivery to Customers
44 a. Medical products should be transported in accordance with the conditions stated on
45 the labels. There should be no risk to the quality of the medical devices during transport
46 and delivery.

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1 b. Delivery vehicles should be suitable for their purpose, with sufficient space and
2 appropriately equipped to protect the products.
3 c. When the medical device is intended solely for professional use, such medical device
4 should be sold to the indicated type of user or to customers with medical prescription
5 only.
6
7 E. Installations and Servicing
8
9 1. Where installation and servicing of a medical equipment are required, these shall be
10 conducted by competent or trained personnel.
11 2. Installation, inspection, any required testing and/or servicing should be performed in
12 accordance with the manufacturer’s instructions and procedures.
13 3. The establishment shall maintain records of inspection and any test results to demonstrate
14 proper installation of the medical equipment. Records of servicing shall likewise be
15 maintained.
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21 F. MEDICAL DEVICE COMPLAINTS
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23 1. The establishment should have a record for each individual complaint. The record should
24 show that the complaints received are investigated and followed through, and that
25 corrective actions are taken to prevent repeated complaints and, where a decision is made
26 to recall the product, the details of the recall.
27 2. There should be a designated personnel to handle complaints.
28
29 G. RETURN OF MEDICAL DEVICES
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31 1. There should be a record for returned medical device products.
32 2. All returned medical devices should be kept separate from saleable stock until a
33 decision has been reached regarding their disposal.
34 3. Returned medical devices shall be re-evaluated and can be returned to saleable stock
35 provided the products have met the following criteria as applicable:
36 a. the medical devices are in their original unopened containers and in good
37 condition;
38 b. it is known that the medical devices have been stored and handled under proper
39 conditions;
40 c. the remaining shelf life period is acceptable; and
41 d. the medical devices have been examined and assessed by appropriate personnel.
42 The assessment should take into account the nature of the medical device, any
43 special storage conditions required, and the time that has elapsed since it was
44 distributed. Special attention should be given to thermolabile medical devices.
45 Advice should be sought from the product owner as necessary.
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1 H. DISPOSAL OF MEDICAL DEVICES

2 1. Medical devices that are expired, contaminated, damaged or defective or found to be
3 counterfeit should be disposed of properly in accordance with applicable government
4 rules and regulations.
5 2. The establishment should ensure that the medical devices for disposal will not be sold.
6 3. The disposal should be properly recorded and such records should be maintained by the
7 establishment.
8
9 I. COUNTERFEIT ADULTERATED OR TAMPERED MEDICAL DEVICES
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11 1. Any counterfeit, adulterated or tampered medical devices found should be physically
12 segregated and stored separately from other medical devices.
13 2. These medical devices should be labeled as “Not for Sale” for easy identification and
14 guidance of the personnel.
15 3. The establishment should inform the Food and Drug Administration – Center for Device
16 Regulation, Radiation Health, and Research, the supplier (importer/distributor) or the
17 product owner immediately regarding the counterfeit, adulterated or tampered medical
18 device product.
19