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|

A notification from the Ministry of Public Health Thailand: Medical Device Risk Base Classification 2019 Effective date 19th December 2019

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The Ministry of Public Health Thailand has published the medical device risk base classification to conform to the ASEAN Agreement on Medical Device Directive (AMDD). This came into effect on the 19th December 2019.

Refer to the Medical Device Act 2008 and the 2nd revision Medical Device Act 2019, there are some modifications as the following:

1) Classify the medical devices into 2 groups
1.1 In Vitro Diagnostic (IVD) Medical Devices
1.2 Non-In Vitro Diagnostic (Non-IVD) Medical Devices

2) To classify IVD medical devices by risk base to individual and public health from low risk to high risk
2.1 Class 1 Medical Device: Low individual risk and Low public health risk
2.2 Class 2 Medical Device: Moderate individual risk and/ or Low public health risk
2.3 Class 3 Medial Device: High individual risk and/ or Moderate public health risk
2.4 Class 4 Medical Device: High individual risk and High public health risk

3) To classify Non-IVD medical devices by risk base that might be occurred from low risk to high risk
3.1 Class 1 Medical Device: Low risk
3.2 Class 2 Medical Device: Low-Moderate risk
3.3 Class 3 Medical Device: Moderate-High risk
3.4 Class 4 Medical Device: High risk
4) TFDA secretary department has authorize to finalize the medical devices classification should there be any issues of medical devices classification
5) There are Medical Device Control for the risk base medical devices classification
5.1 Licensed Medical Devices CSDT Submission
5.2 Notified Medical Devices  CSDT Submission
5.3 Listing Medical Devices* (e-Listing) Non-CSDT Submission
*Amendment of Medical Device Act 2008

6) This notification will be effective on the day after the publication of Thai government gazette
The regulation (Thai version).

MDCD official launch of Medical Devices Risk Classification Tool (Thai version) which is now available online HERE.

2020-02-03T01:28:55+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

Philippines Food and Drug Administration (FDA) releases a draft schedule of fees for Licensing, Registration and Regulatory Services for public comments

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The new draft schedule of fees and charges shall apply to all persons, establishments and health products under the FDA’s jurisdiction. This includes, but is not limited to, national and local government agencies, state colleges and universities, public schools, private entities, and non-governmental organizations who utilize the FDA’s services.

The FDA is rationalizing and streamlining its fee structure to strengthen regulatory enforcement and post-marketing surveillance activities, and to address rising operational costs and expenses for qualified personnel who have technical skills in the evaluation of health products, inspection of establishments and/or laboratory testing. Furthermore, it also aims to sustain the cost of the development, maintenance, and upgrading of information and communication technology and online systems.

The draft new schedule of fees and charges shall apply to all persons, establishments and health products under the FDA’s jurisdiction. This includes, but is not limited to, national and local government agencies, state colleges and universities, public schools, private entities, and non-governmental organizations availing of the FDA’s services.

The new schedule of fees and charges applicable to the Center for Device Regulation, Radiation Health and Research (CDRRHR) is outlined below. The application fees shall not cover the University of the Phillipines Law Center’s Legal Research Fee (LRF), which is equivalent to Php 10.00 or 1% of the application fee, whichever is higher, and the fees incurred from the use of payment collection facilities, such as service fees charged by banks authorized to collect fees on behalf of the FDA.

The application fees for granting the authorization stated in the draft issuance shall cover the expenses of all or any of the following activities:

1) Receiving of application documents;
2) Pre-assessment of received applications for product market authorizations;
3) Pre-marketing activities, including but not limited to assessment, technical evaluation and pre-licensing inspection of establishment;
4) Post-marketing surveillance of products and establishments: (a) Collection of samples (b) Laboratory testing (c) Complaints and reports processing (d) Safety monitoring (e) Post-licensing inspection (f) Routine inspection (g) Pharmacovigilance
5) Printing;
6) Records management and archiving; and
6) Courier services to deliver the authorization.

The FDA plans to implement these revised fees in 2020 (except as otherwise stated in its Annexes).

2020-02-04T13:48:34+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

Malaysian Medical Device (Duties and Obligations of Establishments) Regulations 2019

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The Malaysian Ministry of Health has recently released a regulation on the Duties and Obligations of Establishments of medical devices. The regulations will come into effect on the 1st July 2020.

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The categories of the duties and obligations that are imposed in this regulation are as follows:

1. Distribution records
This section highlights the contents required for a distribution record, the contents required for an implantable medical device distribution record and the period of maintenance required for a distribution record.

2. Records of complaint handling
This section focuses on complaint handling procedures and highlights the requirements for a record of complaint handling and the holding of a complaint record.

3. Mandatory problem reporting
The regulation states than an establishment must submit an investigation report to the Authority within thirty days from the date of the submission of the mandatory report. For incidents that occur outside of Malaysia, if it has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has already been taken by the manufacturer or establishment, the requirement to submit a mandatory report does not apply.

4. Field corrective or preventive action
Establishments shall notify the Authority before undertaking field corrective or preventive action. After the field corrective action or preventive action has been completed, the establishment is required to submit a report to the Authority.

5. Voluntary recall
Before an establishment undertakes a voluntary recall of a medical device, the establishment shall notify the Authority and all those affected by the recall of the medical device within the time frames outlined below:
– for a Class I (high risk) recall, no less than forty-eight hours before the recall is made;
– for a Class II (medium risk), no less than three days before the recall is made;
– for a Class III (low risk), no less than five days before the recall is made.

6. Mandatory recall
The Authority may, in writing, order an establishment to recall any medical device at any time for reasons of patient safety and public health. If the Authority is satisfied with the report of the recall (required by the establishment to undertake), the Authority may close the matter and notify the establishment in writing of its decision.

2020-02-03T01:27:30+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

Medical Device (Advertising) Regulations in Malaysia

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According to the Medical Device (Advertising) Regulations 2019, no person shall advertise any registered medical device without prior approval from the relevant Authority. Any application for approval to advertise a registered medical device must be made to the Authority with the specified documents.

On the 3rd of September 2019, the Malaysian Ministry of Health released a regulation regarding the advertisement of medical devices in Malaysia. This regulation will come into full effect from the 1st of July 2020. The Medical Device (Advertising) Regulations 2019 states that no person shall advertise any registered medical device without approval from the Authority. Any person who commits an offence may be liable to a fine of up to two hundred thousand ringgit or imprisonment for a term not exceeding two years or could be subject to both fine and imprisonment.

An application for an approval to advertise a registered medical device shall be made to the Authority in writing with the following documents:

• a copy of the proposed advertisement for the registered medical device
• a processing fee of one thousand ringgit
• a letter of appointment from the establishment to whom the medical device is registered (if the application is appointed)
The following shall be listed on the advertisement:
• a certificate that the medical device is registered under the Act
• the registration number assigned to the registered medical device

2020-01-13T09:14:09+08:00 December 29th, 2019|Medical Regulation Updates, News & Events|

Vietnam: Business Dialogue Conference on Management of Medical Equipment Regulations

business dialogue

The Ministry of Health, Vietnam has shared with attendees of a business dialogue that the validity of import licenses and the effective date for product licenses Class B, C and D will be extended. The official announcement has been published on the government website..

The Ministry of Health (Department of Medical Equipment and Construction), Vietnam organized a business dialogue conference (3rd of Dec 2019 in Hanoi and on the 14th of Dec 2019 in Ho Chi Minh city) focussing on the regulations of the management of medical equipment and asked for comments on policies supporting the development of domestic production of medical equipment.

The general guidelines about import licenses and product licenses are:
• The import license is valid until 31st of December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid on 31 December 2018) and all import licenses issued in 2019.
• For Class B, C, D medical devices that do not require an import license, importation can continue as normal until 31st of December 2021 without the requirement for a Confirmation Letter from the Vietnamese Ministry of Health.
• Vietnam will apply the Common Submission Dossier Template format until the 1st of January 2022.

In conclusion, the Ministry of Health will expand the valid date for import licenses until the 31st of December 2021 and, the effective date of product licenses for the next two years (1st of January 2022). Every registrant should understand the medical devices that are being registered and the regulations surrounding these.

The new decree is released to public early this month, January 2020. For further information, please refer to the following website: www.dmec.moh.gov.vn

2020-01-13T11:34:42+08:00 December 29th, 2019|Event, Insight, Medical Regulation Updates, News & Events|

Indonesia: Government Regulation PP No. 64 of 2019 on the Change of Tariffs on Registration Renewal

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The Ministry of Health Indonesia has implemented a new tariff on medical device registration renewal with amendment. This new tariff was enacted on the 17th October 2019 after regulation PP No. 64 of 2019 was released.

The Indonesia government has issued a new regulation namely PP No. 64 of 2019 concerning Types and Rates of Non-Tax State Revenues that apply to the Ministry of Health (MoH), which was previously regulated in PP No. 21 of 2013. This new regulation was promulgated on 17 September 2019, and it start implemented 30 days after promulgated, that’s mean since 17 October 2019.
This change of tariff already Socialize by MoH to all distributors in Indonesia. Socialization held by MoH more focused on the information about the change tariff for the Renewal with Amendment.

Below is the tariff changes information.
1. The services of Medical Devices Marketing Authorization

*) PP PNBP No. 21 of 2013: there is an increase of IDR 500,000 for Renewal with Amendment

2. The services of Household Health Supplies (PKRT) Marketing Authorization

*) PP PNBP No. 21 of 2013: there is an increase of IDR 500,000 for Renewal with Amendment

Criteria of change notification or amendment of medical device are as follows:
1. Size
Including addition or reduction of product content and/or size

2. Packaging, including
– Increase or decrease of packaging size
– Addition or reduction of packaging types
– Design change in package shape
– Changes in packaging material

3. Marking
– Language changes in the instructions for use (instructions for use) and/or packaging
– Changes to the logo or symbol, including the halal logo, quality management system, CE, and company logo.
– Changes to product expiration date if stated in the designation
– Changes to product code/type
– Changes in storage temperature
– Improvements to the product name
– Designation of designation markings (color, image, text and layout)1. Size, including:
– Addition or reduction of product content and/or size

4. Accessories/attachments on marketing authorization:
– Accessories
– Type
– Product code
– Product Size

5. Name and/or address of the representative authorized by the Manufacturer, including:
– Change in the name and/or legal address of the manufacturer
– Change in legal entity
– Change in manufacturer’s address due to changes in urban planning
– Change the manufacturer’s name as long as the manufacturer’s address does not move/ change the location
– Change the name of the distributor if the Tax ID Number (NPWP) and business permit number (NIB) do not change
– Change of address of the distributor who moved the province

6. Writing on marketing authorization (typo)

Criteria of change notification or amendment of PKRT device are as follows:
1. Size (for certain products)
2. Packaging
3. Marking
4. Principal’s name and/or address that is not an acquisition, without a change in manufacturer’s name, for imported PKRT.
5. Other changes that do not affect PKRT’s specifications and claims

2019-12-03T04:58:19+08:00 November 26th, 2019|Insight, Medical Regulation Updates, News & Events|

Medical Device-Drug Combination Product Registration in Malaysia

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A guideline for the registration of drug-medical device and medical device-drug combination products has been released and was fully implemented in Malaysia on 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP).

On the 20th June 2019, a guideline for the registration of drug-medical device and medical device-drug combination products was released. This guideline was fully implemented on the 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP). MDDCP is where the primary mode of action on the human body is not based on pharmacological, immunological or metabolic means, but is assisted by the device to the extent that the Medical

The Medical Device Authority (MDA) is the primary agency of the combination product. All medical devices with substances incorporated, that when used on their own could be considered a medical product, must comply with this regulation. All medical devices that fall under Class D, Rule 13 of the Medical Device Regulations 2012 shall conform to this new directive.

Some examples of medical devices that fall under this section include but are not limited to soft tissue filler or dermal filler that incorporates local anesthetic, synthetic fluid tissue reconstructive material that incorporates a pharmacologically active substance, root canal filling incorporating antibiotics, drug-eluting stents, drug-eluting beads, general-body orifice lubricant incorporating local anesthetic and enteral feeding kits that contain an iodine pack drug.

For a medical device-drug combination product registration, where the MDA acts as the primary agency, the registration process shall undergo 3 stages:
• Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)
• Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
• Stage 3 – Application for Registration to the Medical Device Authority (MDA)

Stage 1 – Obtaining Endorsement from the NPRA
Applicant shall submit the following documents to the NPRA manually:
1. Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
2. Ancillary Drug Dossier (Appendix 2)
Note: for the specific labelling requirement, please refer to Appendix 9: Labelling Requirements, released by the NPRA.
Upon satisfactory evaluation, the NPRA shall issue an endorsement letter.

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
Applicants shall submit the documentation to the CAB. The CAB shall issue a certificate and report upon satisfactory conformity assessment.

Stage 3 – Application for Registration to MDA
Once the applicant has obtained the endorsement letter from the NPRA, certificate and report from the CAB, an application (in accordance with the Medical Device Regulation 2012) shall be made on Medcast 2.0 for the MDA to evaluate the medical device application. The MDA shall register the Medical Device-Drug combination product and issue a medical device registration certificate upon approval.

2019-12-03T05:22:33+08:00 November 25th, 2019|Event, Medical Regulation Updates, News & Events|

Reminder of Medical Device status of Non-Corrective Contact Lenses in Malaysia

Contact lenses

Non-corrective contact lenses are also known as cosmetic, decorative, colored or fashion contact lenses. This is a gentle reminder to those non-corrective contact lens manufacturers to register their contact lenses with the Medical Device Authority (MDA) before the devices are placed on the market.

Non-corrective contact lenses were regulated as medical devices by the MDA in Malaysia as of the 1st of January 2018. This is a gentle reminder to those non-corrective contact lens manufacturers to register their contact lenses with the MDA before the devices are placed on the market.
Non-corrective contact lenses are also known as cosmetic, decorative, colored or fashion contact lenses in the market. According to the Medical Device (Declaration) Order 2017, released on the 14th of September 2017, “non-corrective contact lens” means a contact lens which is not used to correct, remedy or relieve any refractive abnormalities or optical defects of sight. Non-corrective contact lenses are used to change the look or color of a user’s eyes. Unlike corrective contact lenses, they do not correct vision.

Non-corrective contact lenses, just like corrective contact lenses can pose serious risks if they are obtained without a prescription or not used correctly. The risks include:

• A cut or scratch on the top layer of the eyeball (corneal abrasion)
• Allergic reactions like itchy, watery red eyes
• Blindness
• Decreased vision
• Infection

All types of contact lenses have associated risks. Thus, the MDA regulate non-corrective contact lenses as medical devices. Manufacturers of non-corrective contact lenses shall obtain ISO 13485 certification. According to the Medical Device Regulations 2012, non-corrective contact lenses shall be considered as Class B or C medical devices, depending on the duration of use.

2019-11-01T05:37:42+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|