Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

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3 FDA CIRCULAR
4 No. __________________
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7 SUBJECT: Good Storage and Distribution Practices for Medical Devices
8 ____________________________________________________________________________
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10 I. RATIONALE
11
12 Good storage and distribution of medical devices are vital in maintaining the quality of
13 medical devices from the supplier to the end user of the product. It is essential that
14 establishments ensure that medical devices are protected from various risks that will
15 adversely affect the quality of these products during the various stages in the supply chain
16 such as purchasing, storage, distribution, transportation and delivery, installation, servicing
17 and maintenance.
18
19 Department of Health Administrative Order No. 2020-0017 entitled “Revised Guidelines
20 on the Unified Licensing Requirements and Procedures of the Food and Drug
21 Administration Repealing Administrative Order No. 2016-0003” provides that all
22 establishments shall provide the appropriate storage condition to maintain the safety and
23 quality of health products. Aside from providing appropriate storage condition, it is
24 equally important that distribution including delivery, transportation, installation,
25 servicing and maintenance are managed appropriately to ensure the quality and
26 performance of medical devices when used by the intended end-users.
27
28 Pursuant to the provisions of Implementing Rules and Regulations of Republic Act No.
29 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009” the
30 functions, powers and duties of the FDA include the development and issuance of
31 policies, standards, regulations, and guidelines that would cover establishments, facilities
32 and health products including medical devices to ensure the safety, quality and efficacy
33 of these products in the market.
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35 In the interest of service and to ensure the quality, safety and performance of medical
36 device during the various points in the supply chain of these health products, this Circular
37 is hereby issued for guidance of all concerned.
38
39
40 II. OBJECTIVE
41
42 This Circular aims to specify the requirements for good storage and distribution practices
43 for medical devices which will serve as guide for medical device establishments engaged
44 in the manufacture, importation, distribution and selling of medical devices in the
45 Philippines.
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47

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

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 1 III. SCOPE
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3 These guidelines shall apply to manufacturers, traders, distributors
4 (exporters/importers/wholesalers) and retailers responsible for the supply of medical
5 devices to another medical device establishments, healthcare facilities, patients or end-
6 users of medical devices.
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8
9 IV. DEFINITION OF TERMS
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11 The terms used in this Circular shall have the meaning as defined in R.A. 9711 and its
12 implementing rules and regulations, Administrative Order (AO) No. 2020-0017 and
13 related laws and regulations. However, for clarity and for purposes of these guidelines,
14 the following terms are defined as follows:
15
16 A. First expiry/first out – refers to a procedure that ensures that the stock with the
17 earliest expiry date is distributed or sold before an identical stock item with a later
18 expiry date is distributed or sold.
19
20 B. First in/first out – refers to a procedure in which the first items to come into the
21 establishment/warehouse are the first items to be distributed or sold.
22
23 C. Good distribution and storage practices – refers to the part of quality assurance
24 that ensures that the quality of medical device products is maintained by means of
25 adequate control throughout the storage thereof and throughout the numerous
26 activities which occur during the distribution process.
27
28 D. Marketing authorization holder (MAH) - refers to the medical device company,
29 corporate or legal entity in whose name the Certificate of Product Registration (CPR),
30 Certificate of Medical Device Registration (CMDR) or Certificate of Medical Device
31 Notification (CMDN) for a medical device has been granted. The MAH is responsible
32 for all aspects of the product, including quality and compliance with the conditions
33 of the issued CPR/CMDR/CMDN. The MAH may be a manufacturer, trader, or
34 distributor (exporter, importer or wholesaler) of medical devices.
35
36 E. Medical Device – any instrument, apparatus, implement, machine, appliance,
37 implant, in-vitro reagent or calibrator, software, material, or other similar or related
38 article intended by the manufacturer to be used alone, or in combination, for human
39 beings for one or more of the specific purpose(s) of diagnosis, prevention,
40 monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment,
41 alleviation of, or compensation for an injury; investigation, replacement,
42 modification, or support of the anatomy or of a physiological process; supporting or
43 sustaining life; preventing infection; control of conception; disinfection of medical
44 devices; and providing information for medical or diagnostic purposes by means of
45 in-vitro examination of specimens derived from the human body. This device does
46 not achieve its primary intended action in or on the human body by pharmacological,
47 immunological or metabolic means but which may be assisted in intended function
48 by such means.
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 1 F. Supplier – refers to a manufacturer, trader, or distributor
2 (importer/wholesaler/exporter) that is engaged in the activity of providing medical
3 device products.
4
5 G. Vermin – refers to a group of insect or small animals such as flies, mosquitoes,
6 cockroaches, lice, bedbugs, mice and rats which are vectors of diseases
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9 V. GUIDELINES
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11 A. RECORDS
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13 1. Records shall be kept for each purchase and sale of medical device showing the
14 following details specified below:
15 a. For manufacturer
16 i. Date of purchase
17 ii. Name of medical device
18 iii. Model number (if applicable)
19 iv. Batch/Lot number (if applicable)
20 v. Expiration date (if applicable)
21 vi. Specification of product (if applicable)
22 vii. Quantity distributed/sold
23 viii. Distribution records
24 ix. CPR/CMDR/CMDN of the product
25 x. Records of full documentation of the registration of the product
26 submitted during registration/notification
27
28 b. Distributor (exporter/importer/wholesaler)
29 i. Date of purchase
30 ii. Name of medical device
31 iii. Model number (if applicable)
32 iv. Batch/Lot number (if applicable)
33 v. Expiration date (if applicable)
34 vi. Specification of product (if applicable)
35 vii. Quantity received and sold
36 viii. Name of licensed supplier
37 ix. Copies of valid LTO of licensed supplier
38 x. Notarized MOA/Contract with supplier /distribution agreement (if
39 applicable)
40 xi. Importation and distribution records
41 xii. Copies of CPR/CMDR/CMDN of the product
42 xiii. ISO certificate for the foreign supplier (manufacturer) or GMP
43 certification for local manufacturers
44 xiv. Records of full documentation of the registration of the product
45 submitted during registration/notification
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 1 c. Retailer
2 i. Date of purchase
3 ii. Name of medical device
4 iii. Model number (if applicable)
5 iv. Batch/Lot number (if applicable)
6 v. Expiration date (if applicable)
7 vi. Specification of product (if applicable)
8 vii. Quantity received and sold
9 viii. Name of licensed supplier
10 ix. Copies of valid LTO of licensed supplier
11 x. Copies of CPR/CMDR/CMDN of the product
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13 2. Records shall be kept for as long as the medical device product is registered with
14 the FDA.
15 3. Records shall show traceability of the origin.
16 4. Proof of delivery transactions shall be kept.
17 5. There shall be an orderly and secure system of filing up to date invoices from
18 suppliers and buyer.
19 6. Records shall be easily retrievable, stored and protected against unauthorized
20 modification, damage, and/or loss of documentation.
21 7. The establishment shall keep records of laws, policies and latest issuances relative
22 to the regulation of medical devices.
23 8. If the records are generated and kept in electronic form, there shall be backups to
24 prevent any accidental data loss.
25
26 B. STANDARD OPERATING PROCEDURES
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28 The establishments shall have standard operating procedures for the following
29 activities:
30 1. Procurement of products
31 2. Release of products
32 3. Transportation / shipment of products including investigation in cases of failure to
33 comply with storage requirement during transit (if applicable)
34 4. Maintenance of vehicle and equipment
35 5. Storage of stocks including temperature monitoring and retention of monitoring records
36 (if applicable)
37 6. Handling of complaints - a distinction should be made between complaints about a
38 product or its packaging and those relating to distribution
39 7. Handling of return of medical devices.
40 8. Handling of product recall including storage and final disposition of recalled products.
41 9. Destruction of medical device (expired, damaged, unusable stocks)
42 10. Handling of medical device products at the port/s of entry (if importer)
43 11. Self-inspection to monitor implementation and compliance with the principles of this
44 guideline and, if necessary, corrective and preventive measures.
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 1 C. PERSONNEL
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3 1. Responsibility and Authority
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5 Establishment shall have an organizational chart and documented job
6 descriptions, including key responsibilities and authorities.
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8 2. Training and Competency
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10 Key personnel in charge including those in the warehousing operations shall
11 possess the necessary competence in terms of education, training, skills and
12 experience. Training may include proper handling, use and operation of the
13 device, as applicable, warehouse management and inventory.
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15 D. PREMISES
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17 1. Cleanliness
18 a. Premises shall be kept clean.
19 b. A written sanitation program shall be available indicating the frequency of
20 cleaning and the methods to be used to clean the premises and storage areas.
21 c. There shall be no smoking, eating and drinking in areas where medical devices
22 are stored and handled.
23
24 2. Vermin Control
25 a. The storage area shall be designed and equipped to prevent entry of vermin
26 and other animals into the area
27 b. There shall be a written vermin control program to prevent vermin infestation.
28 Appropriate records shall be kept for this purpose.
29
30 E. RECEIPT, STORAGE, STOCK HANDLING AND DELIVERY TO
31 CUSTOMERS
32
33 1. Receipt of stocks
34 a. The receiving area shall be adequate and shall have protection for deliveries
35 from bad weather during unloading.
36 b. It shall be separate from the storage area.
37 c. Each incoming delivery shall be checked to ensure that the correct product is
38 delivered from the correct supplier. This may include checking of the purchase
39 order, containers, label description, batch number, expiry date, product and
40 quantity.
41 d. The delivery shall be examined for uniformity of the containers and, if
42 necessary, shall be subdivided according to the supplier’s batch number should
43 the delivery comprise more than one batch.
44 e. Each container shall be carefully checked for possible contamination,
45 tampering and damage. Any suspect containers or, if necessary, the entire
46 delivery shall be quarantined for further investigation.

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 1 f. Medical devices subject to specific storage measures shall be immediately
2 identified and stored in accordance with the specified instruction(s).
3 g. Measures shall be taken to ensure that rejected medical devices cannot be used.
4 They shall be segregated and securely stored while awaiting destruction or
5 return to the supplier.
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7 2. Storage
8 a. Precautions shall be taken to prevent unauthorized persons from entering
9 storage areas.
10 b. Storage areas shall be of sufficient capacity to allow the orderly storage of the
11 different categories of medical devices.
12 c. There shall be adequate lighting and ventilation.
13 d. Storage areas shall be maintained within acceptable and specified temperature
14 limits. The storage conditions for medical devices shall be in accordance with
15 their labelling.
16 e. Where special storage conditions are required on the label (e.g. temperature,
17 relative humidity), these shall be provided, controlled, monitored and recorded.
18 Temperature of the storage areas shall be measured at suitable predetermined
19 intervals to show the maximum and minimum temperatures for the day and
20 recorded. The equipment used for monitoring shall be calibrated and be
21 suitable for their intended use. Calibration shall be traceable to applicable
22 international/national standard and the calibration records shall be maintained.
23 f. Medical devices shall be stored off the floor and suitably spaced to allow
24 cleaning and inspection. If pallets are used, such shall be well maintained and
25 kept clean at all times.
26 g. Medical devices shall be handled and stored in such a manner as to prevent
27 contamination, mix-ups and cross-contamination.
28 h. Appropriate and suitable storage conditions shall be provided for hazardous,
29 sensitive and dangerous materials such as combustible liquids and solids,
30 pressurized gases, highly toxic and radioactive substances.
31 i. There shall be designated areas for quarantined, saleable stock, expired,
32 rejected/damaged, recalled and returned medical devices. Such medical
33 devices shall be properly labeled.
34 j. A list of medical devices shall be maintained and the medical devices properly
35 identified.
36
37 3. Stock Control and Rotation
38 a. Periodic stock reconciliation shall be performed at defined intervals by
39 comparing the actual and recorded stock. The root cause for stock discrepancies
40 shall be identified and appropriate corrective and preventive action taken to
41 prevent recurrence.
42 b. Stock shall be appropriately rotated. The “first expiry/first out” principle shall
43 be followed. For cases where the medical devices do not have expiry dates,
44 “first in/first out” shall be applied. If there is a manufacturing date, the product
45 with the earlier manufacturing date shall be first to be released.
46 c. All stock shall be checked regularly to identify obsolete and expired stock.

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 1 d. Medical devices with broken seals, damaged packaging or suspected
2 tampering/contamination shall not be sold.
3 e. Medical devices bearing an expiry date shall not be sold close to the expiry date
4 such that the expiry date is likely to occur before the consumer uses the medical
5 devices. Expired medical devices shall not be distributed or sold to consumers.
6 f. All labels and containers of medical devices shall not be altered, tampered or
7 changed.
8 g. If the name and address of the Marketing Authorization Holder (MAH) and the
9 CPR/CMDR.CMDN of the medical device are not indicated on the product’s
10 label, the MAH shall affix a sticker on the label indicating the said mandatory
11 labeling requirements on the medical device pursuant to the provisions of
12 Administrative Order No. 2018-0002 entitled “Guidelines Governing the
13 Issuance of an Authorization for a Medical Device based on the ASEAN
14 Harmonized Technical Requirements”.
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16 4. Delivery to Customers
17 a. Medical products shall be transported in accordance with the conditions stated
18 on the labels. There shall be no risk to the quality of the medical devices during
19 transport and delivery.
20 b. Delivery vehicles shall be suitable for their purpose, with sufficient space and
21 appropriately equipped to protect the products.
22 c. When the medical device is intended solely for professional use, such medical
23 device shall be sold to the indicated type of user or to customers with medical
24 prescription only.
25
26 F. INSTALLATIONS AND SERVICING
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28 1. Where installation and servicing of a medical equipment are required, these shall
29 be conducted by competent or trained personnel.
30 2. Installation, inspection, any required testing and/or servicing shall be performed in
31 accordance with the manufacturer’s instructions and procedures.
32 3. The establishment shall maintain records of inspection and any test results to
33 demonstrate proper installation of the medical equipment. Records of servicing
34 shall likewise be maintained.
35
36 G. MEDICAL DEVICE COMPLAINTS
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38 1. The establishment shall have a record for each individual complaint.
39 The records on complaints may include the following information:
40 a. the medical device brand name, CPR/CMDR/CMDN number,
41 model/catalogue number or bar code, control/serial/ lot number
42 and any other means of identification of the medical device;
43 b. the name(s) and address(es) of the supplier;
44 c. records pertaining to the problem investigation.
45 2. The record shall show that the complaints received are investigated and followed
46 through, and that corrective actions are taken to prevent repeated complaints and,

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 1 where a decision is made to recall the product, the details of the recall.
2 3. There shall be a designated personnel to handle complaints.
3 4. The written standard operating procedures for handling of complaints shall
4 identify the designated personnel and describe his/her functions and
5 responsibilities. The procedure shall contain the following:
6 a. determination of whether there is a health hazard associated with the medical
7 device;
8 b. determination of whether the medical device fails to conform to any claim
9 made by the dealer relating to its effectiveness, benefits, performance
10 characteristics or safety;
11 c. determination of whether the medical device fails to meet any regulatory
12 requirements
13 d. determination of the most appropriate preventive/corrective action;
14 e. justification when no action is taken, for example, in the case of receiving
15 an unfounded or invalid complaint.
16 5. Complaint records maintained with respect to a medical device should be retained
17 for a period of five (5) years on top of the projected useful life of the medical
18 device as determined by the product owner. For example, if the projected useful
19 life of the medical device is one year, the complaint records should be kept for six
20 years.
21
22 H. RETURN OF MEDICAL DEVICES
23
24 1. There shall be standard operating procedures for handling of return of medical
25 devices.
26 2. There shall be a record for returned medical device products.
27 3. All returned medical devices shall be kept separate from saleable stock until a
28 decision has been reached regarding their disposal.
29 4. Returned medical devices shall be re-evaluated and can be returned to saleable
30 stock provided the products have met the following criteria as applicable:
31 a. the medical devices are in their original unopened containers and in good
32 condition;
33 b. it is known that the medical devices have been stored and handled under
34 proper conditions;
35 c. the remaining shelf life period is acceptable; and
36 d. the medical devices have been examined and assessed by appropriate
37 personnel. The assessment shall take into account the nature of the medical
38 device, any special storage conditions required, and the time that has elapsed
39 since it was distributed. Special attention shall be given to thermolabile
40 medical devices. Advice shall be sought from the product owner as
41 necessary.
42
43 I. DISPOSAL OF MEDICAL DEVICES
44 1. Medical devices that are expired, contaminated, damaged or defective or found to
45 be counterfeit shall be disposed of properly in accordance with applicable
46 government rules and regulations (e.g. FDA Circular No. 2016-012 entitled
47 “Guidelines on Product Recall”)

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 1 2. The establishment shall ensure that the medical devices for disposal will not be
2 sold.
3 3. The disposal shall be properly recorded and such records shall be maintained by the
4 establishment.
5
6 J. RECALLED, COUNTERFEIT, ADULTERATED, TAMPERED, BANNED,
7 PHASED-OUT, UNUSABLE MEDICAL DEVICES
8
9 1. Any recalled, counterfeit, adulterated, tampered, banned, phased-out or unusable
10 medical devices shall be physically segregated and stored separately from other
11 medical devices. For recalled products, the establishment shall comply with FDA
12 Circular No. 2016-012 entitled “Guidelines for Product Recall”.
13 2. These medical devices shall be labeled as “Not for Sale” for easy identification and
14 guidance of the personnel.
15 3. There shall be a designated personnel to handle recalled, counterfeit, adulterated,
16 tampered, banned, phased-out or unusable medical devices.
17 4. The establishment shall inform the Food and Drug Administration – Center for
18 Device Regulation, Radiation Health, and Research, the supplier
19 (manufacturer/trader/distributor) or the product owner immediately regarding the
20 recalled, counterfeit, banned, adulterated or tampered medical device product.
21
22
23 VI. PENALTY CLAUSE
24
25 Sanctions over violations of any of the provisions of this FDA circular shall be imposed
26 after notice and hearing following Book III Uniform Rules of Procedures or in
27 accordance with Book II, Article I, Section 4. Grounds for Disapproval of Application
28 and Suspension or Cancellation of License, Registration, or Authorization provided in
29 the Implementing Rules and Regulations of RA 9711.
30
31
32 VII. SEPARABILITY CLAUSE
33
34 In the event that any provision or part of this Circular is declared invalid, the other
35 provisions hereof shall not be affected.
36
37
38 VIII. TRANSITORY PROVISION
39
40 All existing licensed medical device establishment prior to the issuance of this Circular
41 shall be given a period of two (2) years from the effectivity of this Circular to comply
42 with the provisions thereof.
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 1 IX. EFFECTIVITY
2
3 This Circular shall take effect fifteen (15) days following its publication in a newspaper
4 of general circulation and upon filing three (3) certified true copies with the University
5 of the Philippines Law Center - Office of the National Administrative Register.
6 .
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9 FRANCISCO T. DUQUE III, MD, MSc
10 Secretary of Health
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13 DTN: 20210622173821
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