Thailand’s Ministry of Public Health has announced the Draft of a new set of medical device definition for manufacturers and importers to follow when registering their medical devices according to risk-based classification.

As we were informed prior in Qualtech’s June 2020 Newsletter, ThaiFDA is currently in a transition phase from policy-based classification to risk-based classification of medical devices. Currently, medical devices are classified according to the level of risk that may cause harm or impact on public health. Policy based classification comprises of Class I (Licensed Medical Devices, highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).

As Thailand has aligned with the ASEAN AMDD, the medical device risk classification will be shaped to guidelines on risk classifications as outlined by the AMDD. Respective to the complete transition, ThaiFDA will no longer categorize medical devices by their common names and use policy-based classification. The complete list of medical device which will be regulated as per risk-based classification can be consulted in the draft announcement.

The translated list is as following:

No

Category of Rules

Description of Rules

(1)

IVD Medical Device

(1) IVD medical devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to access their suitability for transfusion or transplantation.

(2) IVD medical devices in detecting the presence of, or exposure to, a sexually transmitted agent (e.g. Sexually transmitted diseases, such as Chlamydia trachomatis, Neisseria gonorrhoeae).

(3) IVD medical devices in detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation (e.g. Neisseria meningitidis or Cryptococcus neoformans).

(4) IVD medical devices in detecting the presence of an infections agent where there is a significant risk that an erroneous result would cause death or severe disability to the individual or fetus being tested (e.g. diagnostic assay for CMV, Chlamydia pneumoniae, Methycillin, Resistant Staphylococcus aureus).

(5) IVD medical devices in pre-natal screening of women in order to determine their immune status towards transmissible agents (e.g. Immune status tests for Rubella or Toxoplasmosis).

(6) IVD medical devices in determining infective disease status or immune status, and where there is a risk that erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient (e.g. Enteroviruses, CMV and HSV in transplant patients). 

(7) IVD medical devices in screening of selection of patients for selective therapy and management, or for disease staging, or in the diagnosis of cancer (e.g. personalised medicine).

(8) IVD medical devices in human genetic testing (e.g. Huntington’s Disease, Cystic Fibrosis).

(9) IVD medical devices intended to be used to monitor levels of medicines, substance or biological components, when there is a risk that an erroneous result will lead to a patient management decisions resulting in an immediate life-threatening situation for the patient (e.g. Cardiac markers, cyclosporin, prothrombin time testing).

(10) IVD medical devices intended to be used in the management of patients suffering from a life-threatening infections disease (e.g. HCV viral load, HIV Viral Load and HIV and HCV geno-and subtyping).

(11) IVD medical devices in screening for congenital disorders in the fetus (e.g. Spina Bifida or Down Syndrome). 

(12) IVD medical devices intended for self-testing.

(13) IVD medical devices untended for blood gases and blood glucose determinations for near-patient testing.

(14)  IVD medical devices that are controls without a quantitative or qualitative assigned value.

(2)

Medical Device other than IVD Medical Device

(1) All non-invasive medical devices which encounter injured skin that are intended to be used principally with wounds which have breached the dermis, including medical devices principally intended to manage the microenvironment of a wound.

(2) All non-invasive medical devices which encounter injured skin that are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent.

(3) All non-invasive medical devices intended for channelling or storing

- they may be connected to an active medical device or a higher class

- channelling blood

- storing or channelling other body liquids

- for soring organs, parts of organs or body tissues,

- blood bags

(4) All non-invasive medical devices intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for

- infusion into the body

- the treatment consists of filtration, centrifuging or exchanges of gas or the heat.

(3)

Invasive Medical Devices

(1) All invasive medical devices with respect to body orifices (other than those which are surgically invasive) and which are not intended for connection to an active medical device or are intended for connection to Class 1 medical device only include:

- product that are intended for use on the external surface of any eyeball; or t is liable to be absorb by the mucous membrane.

- products that are intended for short-term use

- product that are intended for long-term use

(2) All invasive medical devices with respect to body orifices (other than those which are surgically invasive) and which are intended to be connected to an active medical device in Class 2, or higher Class.

(3) All invasive medical devices intended for transient use. All invasive Medical devices that are not included are as follows: reusable surgical instruments; all invasive medical devices that are intended specifically for use in direct contact with the central nervous system; all invasive medical devices that are intended especially to diagnose, monitor or correct a defect of the heart or od the central circulatory system through direct contact with these part of the body.

(4) All invasive medical devices intended for short-term use. All invasive Medical devices that are not included are as follows: reusable surgical instruments; all invasive medical devices that are intended specifically for use in direct contact with the central nervous system; all invasive medical devices that are intended especially to diagnose, monitor or correct a defect of the heart or od the central circulatory system through direct contact with these part of the body.

(5) All implantable medical devices, and long-term surgically invasive medical devices, and not medical devices with high risk.

(4)

Active Medical Devices

(1) All active therapeutic medical device includes:

- intended to administer or exchange energy

- administer or exchange energy to or from the human body in a potentially hazardous way, including ionising radiation, taking account of the nature, the density and site of application of the energy.

(2) All active medical devices intended to control or monitor the performance of active therapeutic medical devices in Class 3. Or intended directly to influence the performance of such medical devices.

(3) Active medical devices intended for diagnosis.

(4) Active medical devices intended to emit ionising radiation and intended for diagnostic and/or interventional radiology.

(5) Active medical devices intended to image in vivo distribution of radiopharmaceuticals

6) Active medical devices intended to allow direct diagnosis or monitoring of vital physiological processes.

(7) Active medical devices specially intended for monitoring of vital physiological parameters, where the nature of variation is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system

(8) Active medical devices specially intended for diagnosing in clinical situation where the patient is in immediate danger.

(9) Active medical devices intended to emit ionising radiation and intended for diagnostic and/or interventional radiology, including medical devices which control or monitor such medical devices, or those which directly influence their performance.

(10) All active medical devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body.

(11) All active medical devices intended to be used in manner that is potentially hazardous, taking account of the substances involved, of the part of the body concerned and of the mode and route of administration or removal.

(5)

Additional Rules

(1) All medical devices intended specially to be used for sterilizing medical devices or disinfecting as the end point of processing.

(2) All medical devices intended specially to be used for disinfecting medical devices prior to end point sterilization or higher-level disinfection

(3) All medical devices intended specially to be used for disinfecting, cleaning, rinsing or, when appropriate. Hydrating contact lenes.

(4) All medical devices used for contraception or the prevention of the transmission of sexually transmitted diseases

     

RECOMMEND READING

- Thailand Registration Introduction

- Ministry of Public Health Announces the Draft regarding Academic Documents Preparation for Inspection Purpose – July,2020


References:

  1. Ministry of Public Health Announces the Draft regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Notified Registration (No.2) 2020

 

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