Overview of the e-Catalogue in Indonesia

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The use of the e-Catalogue in Indonesia makes the procurement of goods/services in the public sector more efficient. Shorter procurement times and fair competition partners ensure the government is getting the best price.

The Electronic Catalogue (e-Catalogue) is an electronic information system that lists the technical specifications and prices of certain goods and services from various providers. The e-Catalogue was created by the Government Goods/Services Procurement Policy Agency, Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah (LKPP), at the end of 2012.

Some of the benefits of using the e-Catalogue are:

  1. It makes the process of procurement of goods/services in the public sector more efficient. Shorter procurement times and competition partners ensure the government is getting the best price.
  2. The e-Catalogue also increases transparency. This can supress the problem of budget leakage that often occurs in the procurement of goods/services.
  3. It simplifies the process, making it more inviting for partners to participate.

An e-Catalogue of medical devices has been promoted since 2015. The next opening date for procurement of the medical devices e-catalogue is yet to be announced. The LKPP will announce it on their website (http://lkpp.go.id).

Once announced, the LKPP will aim to inform all those medical device distributors who may want to join the e-Catalogue. LKPP will then issue an invitation to all registered companies to meet. At the meeting, the LKPP will explain the procedures for the opening bid schedule and any requirements. All information shared by the LKPP will be available in the bid document. This is normally shared on the LKPP website and can be downloaded.

Documentation required by the LKPP:
1. Offering Letter
2. Qualification Form
– Deed of establishment
– Latest amendment to the deed of establishment (if any)
– Business License Number (NIB)
– Tax ID number
– Latest annual tax notification (typically LKPP will mention the latest year that can be used)
– Medical Device Distribution Certificate (referred to as IPAK)
– Letter of Authorization with Principle/Manufacturer
3. Integrity Pact
4. Technical Bid Documents
– Technical specification of the product
– Statement letter of product warranty (at least one year).
– Statement letter of guaranteed availability of spare parts for at least 5 years.
– Registration Certificate issued by Ministry of Trade (referred to as Surat Tanda Pendaftaran or STP)
– Approval License issued by Ministry of Health
5. Bidding Documents
– A price list of government and non-government offers for each product
– Bid price in Indonesian Rupiah (IDR)
– Imported products must include the most recent Goods Import Declaration (called the PIB) and the item purchase invoice.

The LKPP values those bids that provide:
1. Evaluation and proof of qualifications
2. Administrative evaluation
3. Technical evaluation
4. Negotiation

The LKPP will seek further clarification from those who have submitted all the required documentation. They will also check copy documents against the original hardcopy. If complete and eligible, the LKPP will invite eligible producers into a negotiation on product price.

The LKPP will issue a contract of catalogue to those successful in negotiations. This is a co-operation agreement signed by the LKPP and the provider for inclusion of goods/services in an e-Catalogue for two years. After receiving the contract of catalogue, providers can submit the agreed upon product into the e-catalogue system: http://e-katalog.lkpp.go.id/

2020-03-02T03:26:18+08:00 February 27th, 2020|Event, Insight, News & Events|

Vietnam: Import Duty Exemption for Selected Medical Devices Amid COVID-19 Outbreak

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The Ministry of Finance have assigned the General Department of Customs to direct and guide customs units to implement the tax exemption policy for imported goods in order to prevent and control the Covid-19 epidemic.

The Minister of Finance, Mr. Dinh Tien Dung, has announced a tax exemption on imports of five commodity groups that are needed to fight the novel coronavirus. On February 7th 2020, authorities signed Decision 155/QĐ-BTC allowing import tax exemptions on medical masks, hand sanitizer, mask materials, disinfectant and protective clothing.

The Ministry of Finance (MoF) has assigned the General Department of Customs to direct and guide customs units to implement the tax exemption policy for imported goods to prevent and control the epidemic. Customs offices will carry out customs clearance for goods in the groups and will also work with relevant agencies to inspect and ensure importation is for the correct purposes.

The groups of goods subject to exemption include:
– Medical masks with international harmonized system (HS) codes* of 6307.90.40 and 6307.90.90.
– Disinfectant gel or liquid hand sanitizer with HS code 3808.94.90.
– Mask materials include non-woven fabrics and antibacterial filters; elastic bands with the regulated HS codes.
– Disinfectants with HS codes of 3808.94.20 and 3808.94.90.
– Protective clothing including trousers, shirts, goggles, medical masks, helmets, gloves and shoes with HS code 6210.10.90.

This decision took effect from February 7th 2020 until the end of the epidemic.
*HS code stands for the Harmonized System code describing the type of goods

2020-03-02T03:29:16+08:00 February 26th, 2020|Event, Insight, News & Events|

Philippines: Custom’s New Alert Order Monitoring System

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The written alert order form will serve as the notice of alert to the recipient offices prompting them to take 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 the Bureau of Customs.

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.”

2020-03-02T03:32:18+08:00 February 26th, 2020|Insight, Medical Regulation Updates, News & Events|

Indonesia: Purpose of GDPMD and its Implementation

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Good Distribution Practice of Medical Devices, which will be referred to here as CDAKB, is a guideline used in a series of distribution and quality control activities aimed at ensuring that distributed medical device products meet the requirements of their intended use.

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.

2020-03-02T03:35:34+08:00 February 26th, 2020|Insight, Medical Regulation Updates, News & Events|

COVID-19 Impact on the Medical Industry and Measures by Health Science Authority, Singapore

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In order to deal with the current ‘’out of stock’’ and overly inflated prices of surgical masks, hand sanitisers, respirators, thermometers and protective gear due to the COVID-19 outbreak, the HSA in Singapore has put measures in place by restricting import of these ‘’high in demand commodities’’

In recent times, one of the most talked about topics in the world is the rise of the novel coronavirus strain, officially named COVID-19. The virus is severely contagious and is having a worldwide impact.

It is not easy to miss the snaking queues at pharmacies for surgical masks, sanitisers, protective clothing and pretty much anything else that claims to have antiseptic & antibacterial properties. Pharmaceutical companies are also making a lot more money by selling immune boosting supplements and flu medications. People are being overly conscious and cautious with flu like symptoms, especially in those countries with a greater presence of positive COVID-19 cases.

Medical device companies are experiencing increased sales by catering to the need for diagnostic kits, protective clothing, gloves, testing equipment, x-ray machines etc. Although the medical and pharmaceutical device industries are experiencing increased sales, they are also providing funds for research into the cure and treatment of the virus.

In order to deal with the current ‘’out of stock’’ labels and overly inflated prices of surgical masks, hand sanitisers, respirators, thermometers and protective gear, the HSA has put measures in place by restricting the import of these ‘’high demand commodities’’ for personal use beyond certain quantities. In an attempt to tackle the risk of substandard products in the Singapore market, they have also implemented easier importation options for dealers by forgoing the need for an ‘’Importer’s License by the HSA’’. During this time, importers only need to notify an intention to import to the authority. They also need to provide information regarding the brand and quantity of devices that are to be imported into Singapore. It is expected that they maintain proper sales and distribution records. These records will later be subject to submission to the HSA.

2020-03-02T03:37:50+08:00 February 26th, 2020|Event, Insight, News & Events|

FDA officially issued the Circular for Initial Implementation of AO 2018-002.

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Circular 2020-001 aims to provide information regarding the acceptance of applications based on AO 2018-002, validity of issued Certificate of exemption, and application fees for marketing authorizations. It also provides guidance regarding the classification of medical devices listed in FDA Memo Circular 2014-005 and 2014-005A according to the risk level.

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.

2020-02-03T09:26:13+08:00 February 3rd, 2020|Insight, Medical Regulation Updates, News & Events|

The Role of the Ministry of Health Directorate of Surveillance in improving the Quality, Safety and Efficacy of Medical Devices in Indonesia

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In order to guarantee that medical devices and household health supplies meet quality, safety and efficacy requirements, products must obtain a marketing authorization number. This is evaluated by the Directorate of Assessment, Indonesia prior to product distribution

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.

2020-02-03T01:34:16+08:00 February 3rd, 2020|Insight, Medical Regulation Updates, News & Events|