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|