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|