Monthly Archives: February 2020

The Bureau of Custom’s (BOC) new alert order monitoring system (AOMS) is now operational. Customs Memorandum Order (CMO) No. 47-2019 was dated and signed on September 11 2019 by Customs commissioner, Rey Leonardo Guerrero. This implements Customs Administrative Order (CAO) No. 07-2019, CMOs 19-2018 and 6-2019, and other BOC rules covering alert orders. The AOMS will be used by the Alert Order Clearing House Desk (AOCHD)—the central clearing house created through CAO 07-2019—to monitor alert orders issued by various authorized officers of BOC.

An alert order is a written order issued by the customs commissioner, the district collector, or other customs officers authorized in writing by the commissioner, after the goods declaration is lodged and before the goods are released from customs custody. Under CAO 07-2019, the alert order can be issued upon critical information regarding possible non-compliance with the Customs Modernization and Tariff Act and other laws, rules and regulations enforced by BOC.
Once issued by the alerting authority, the written alert order form should be forwarded within an hour to the relevant port’s Formal Entry Division, the Office of the Deputy Collector for Operations, the District Enforcement and Security Service, the District Customs Intelligence and Investigation Service, the District Customs Anti-illegal Drugs Task Force, and the X-ray Inspection Project field office.

The written alert order form will serve as the notice of alert to the recipient offices, causing them to take prompt and appropriate action. Alert orders may be provisionally lifted if the district collector orders the examination of goods on the consignee’s premises or in examination areas approved by BOC. The district collector may also allow transfer of the alerted goods for examination in certain circumstances, such as perishable goods, and goods that could be easily damaged during examination.

Other cases for provisionally lifting alert orders include the following:
-The receiving operator does not have the equipment or facility to perform an examination
-The examination at the consignee’s premises or warehouse is a privileged area, protected under law or existing rules and regulations
-The containers have been subjected to initial 10% physical examination and there were no adverse findings
-Other instances as may be approved by the district collector or port collector.

If the AOMS cannot be accessed, the concerned offices should implement interim manual procedures that will minimize disruption to the processing of alert orders. Once AOMS access is restored, documents and transactions processed manually should be added to the AOMS, (as per CMO 47-2019). Physical examination or non-intrusive inspection should be made within 48 hours of receipt of the alert order or pre-lodgement control order (PLCO) by the district collector’s office. Exceptions apply in cases where elements are beyond their control, such as, but not limited to, the unavailability of equipment required for examination, force majeure (removing liability for natural disaster), or other fortuitous event.

A PLCO is a written order (under CAO 07-2019 ) issued by the Customs commissioner, the district collector, or other customs officers (must be authorized in writing by the commissioner), before the goods declaration is lodged or when no goods declaration is lodged. This is to prevent the illegal importation or their release. BOC personnel found to have violated the provisions of CMO 47-2019 will face the “appropriate civil and/or criminal liability and any administrative sanctions that may be imposed by the BOC.”

Medical devices are different from ordinary commodities. They are an industrial product with distribution requirements to ensure that safety, quality and functionality can be guaranteed.

Improper handling during distribution activities can negatively impact upon the safety, quality, and benefits of medical devices. Distributors of medical devices in Indonesia(PAK) have an important role in ensuring the safety, quality, and benefits of medical devices.

In order to guarantee safe, quality and functional medical devices, the distribution system must comply with the Guidelines for the Distribution of Good Medical Devices issued by the government as specified in PERMENKES No. 4 of 2014.

Good Distribution Practice of Medical Devices, referred to as CDAKB, is a guideline for distribution and quality control activities. The aim of this guideline is to ensure distributed medical device products meet the requirements of their intended use.

Purpose and Benefits of the Application of CDAKB
1. Quality
The process of continual improvement to maintain the quality of distributed medical products
2. Management System
Application of Management System in the distribution process
3. Regulation
Compliance with state regulations.

According to the MoH in Indonesia, there is a possibility that every distributor who deals with medical devices will need to implement CDAKB as a mandatory requirement in 2021. This is yet to be confirmed. The application of CDAKB can ensure safe, quality and functional medical devices that meet the needs of the community while also maintaining patient safety.

FDA Circular 2020-001: Initial Implementation AO 2018-002: Guidelines Governing the Issuance of An Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements, was issued by the Food and Drug Administration in the late afternoon January 24, 2020.

The Circular aims to provide information regarding the acceptance of applications based on AO 2018-002, validity of issued Certificate of exemption (COE), and application fees for marketing authorizations. It also aims to provide guidance for the medical device industry and all concerned regarding the classification of medical devices listed in FDA Memo Circular 2014-005 and FDA Memo Circular 2014-005A according to the level of risk.

Specific policies and guidelines of the circular are outlined as follows:
1.) FDA CDRRHR shall be accepting applications for the following marketing authorizations:
 Certificate of Medical Device Registration (CMDR) for Class B, C, and D included in the FDA Memorandum Circular 2014-005 and 2014-005A (see Annex A).
 Certificate of Medical Device Notification (CMDN) for all Medical Devices with risk classification A whether or not included in FDA Memorandum Circular 2014-005 and 2014-005A.
 Certificate of Medical Device Listing (CMDL) for research, clinical trial, exhibit, personal use and/or donated, brand new medical devices.
2.) Classification of Medical Devices not included in Annex A shall follow the classification rules of AMDD.
3.) All COE for Class A medical Devices issued from Feb 25, 2014 shall remain valid only until Nov 3, 2021 or within 2 years from date of effectivity of the Circular whichever is earlier.
4.) All CPR issued for Class A Medical Devices shall be deemed equivalent to CMDN only until validity of the CPR. CMDN shall be issued upon renewal of the issued CPR.
5.) Blood collection tube shall be added under the list of IVD since it has been re-classified as in-vitro diagnostic (IVD) medical devices based on definition of IVD in the ASEAN AMDD.
6.) Issuance of COE shall cease. All Class B, C and D medical devices not included in Annex A and IVD not included in FDA Memo Circular 2014-005 shall be considered non-registrable products. The License to Operate of establishment shall be provided in lieu of COE at the point of entry and/or as part of the bidding requirement.
7.) The fees shall be in accordance with AO 50s. 2001, until such time of modification, supersession, and/or revocation, with the following clarification:
a. Initial application CMDN & CMDR is Php 7,500 + 1% Legal research fee (LRF) x 5 years
b. Renewal applications of CMDN & CMDR is Php 5,000 + 1% Legal research fee (LRF)
c. Application for CMDL is Php 500 + 1% Legal research fee (LRF)
8.) Additional details shall be provided in subsequent issuances regarding the succeeding phases.
Effectivity of the circular shall take effect 15 days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the Office of the National Administrative Register.

Based upon the Ministry of Health (MoH) regulatory PERMENKES No. 64 of 2015 (concerning the Organization and Work Procedures of the MoH), the Directorate of Production and Distribution of Medical Devices is divided into two directorates:
1. Directorate of Assessment of Medical Device and Household Health Supplies;
2. Directorate of Surveillance of Medical Device and Household Health Supplies

After a product receives a marketing authorization number from the Directorate of Assessment, it can be distributed. At this stage, it is the task of the Directorate of Surveillance to provide supervision of the distributed product. The purpose of supervision is to ensure that medical devices and household health supplies meet the appropriate standards and/or requirements, thereby preventing and controlling any potential consequences that arise from misuse and abuse. This also provides legal certainty, creates a healthy business climate and furthermore, protects the public from the dangers of using medical devices and household health supplies that do not meet the quality, safety and efficacy requirements.
The activities conducted by the Directorate of Surveillance to achieve the aforementioned purposes are listed below:

1. Sampling and Testing
Sampling and testing are conducted by MoH Surveillance when a product is widely used by the public or, when a product has experienced an adverse event. These aim to protect the public from using products that do not meet quality and safety requirements and to ensure product consistency. It also serves as a way to detect the presence of fake or illegal products.

2. Advertising and Labelling Control
Supervision of advertising and labelling are conducted with the aim of protecting the public from misleading information, avoiding dangers/adverse effects, preventing harm to the environment, and preventing material and immaterial losses due to improper use.  Advertising and labelling are required to be objective, ethical and should not use misleading information or language that can be open to interpretation.

3. Vigilance System Supervision
Vigilance System Supervision is part of the Medical Device Supervision with the aim of preventing the recurrence of the same event and to correct any unexpected event. An unexpected event can still occur with products despite passing the assessment stage. An unexpected event is defined as one in which serious injury, death or deterioration in the health of patients, users or others is caused directly or indirectly by a product defect (damage or failure, decreased performance, or inadequate marking or instructions for use).  Events can be reported by distributors, health service facilities, and the public/patients users of the product.

4. Clinical and Technical Information Audit
This activity is also included in the role of MoH Directorate Surveillance.