Home About Qualtech NEWS THAILAND: ThaiFDA Issues the Amended Medical Device Act (Issue 2) B.E. 2562 (2019) – June, 2019
THAILAND: ThaiFDA Issues the Amended Medical Device Act (Issue 2) B.E. 2562 (2019) – June, 2019

June 11, 2019

Medical Device Act (Issue 2) B.E. 2562 (2019), enacted by the King Rama 10th, by and with the advice and consent of National Legislative Assembly, is divided into 16 Sections as follows:

1) Introduction Section: In this section, Thailand government improves the registration regulatory by amended 2 definition terms;

a) Accessory: means goods, appliances or products that the manufacturer or the owner of the product specifically intended to be used in conjunction with medical devices to help or make the medical device usable according to the purpose of the medical device.                              b) Registrant: means the recipient of a registration certificate receipt under this Act; in the case where the recipient of a registration certificate is a juristic person, it shall also include a person appointed or designated by the juristic person to administer operations.

2) Chapter I - Board of Medical Device: In this section, Thailand government improves board of medical device by an amendment in giving approval to the Secretary-General in the issuance of the announcement under this Act.

3) Chapter II - Registration of Establishments, License Applications and Licensing and Specification Declaration and Registrant: In this section, Thailand government improves the registration regulatory by an amendment in Registrant License; application, renewal and replace of License.

4) Chapter II - Part I Medical Device Evaluation Procedure: In this section, Thailand government improves the registration regulatory by an amendment of this Part 1, dedicated for a clarification of Medical Device documents evaluation procedure for all License issuing.

5) Chapter III - Cessation and Transfer of Operations: In this section, Thailand government improves the registration regulatory by an amendment for registrant to have an equal right in case for transfer of operations with establishment registrant, Licensee or specifications providers’ death, and an heir or person authorized by their expresses to the licensor an intent to continue with the operations within ninety days as from the death of the establishment registrant, registrant, licensee, or specifications provider.

6) Chapter IV - Duties of Establishment Registrants, Licensees, Specifications Providers, Registrants and Vendors: In this section, Thailand government improves the registration regulatory procedure by an amendment of addition of registrant duties in equivalent to an establishment registrant, licensee or specifications provider shall not manufacture, import, sell or store medical devices in a place other than as specified in the establishment registration certificate license or specifications declaration receipt.

7) Chapter V - Labeling and Medical Device Documentation: In this section, Thailand government improves the registration regulatory by the amendment of addition of registrant for labeling and medical device document in equivalent to establishment registrant, licensee or specifications provider who manufactures or imports medical devices shall provide for labels and medical device documentation which shall must not contain false or exaggerated messages.

8) Chapter VI - Control of Medical Devices: In this section, Thailand government improves the registration regulatory by the amendment that no person shall manufacture, import or sell the medical devices that is manufactured or imported not in conformity with a license, declared specification or registered.

9) Chapter VII - Advertisement: In this section, Thailand government improves medical device advertisement regulatory by the amendment that for medical device advertising directly to medical and public health professionals, the Minister with the advice of the Committee shall have the power to prescribe medical devices. As well as the rules, procedures and advertising conditions that are exempted from submission of license.

10) Chapter VIII - Competent Official: In this section, Thailand government improves competent official workflow system by the amendment that A licensee, specifications prover, registrant and a person having duties related to manufacture, import, sell or storage of medical device shall assist a competent official executing duties under section 61 and section 66 paragraph two.

11) Chapter IX - Suspension and Revocation of Establishment Registration Certificate, Licensed or Specification Declaration Certificate or Registration Certificate: In this section, Thailand government improves the registration regulatory by the amendment that for the benefit of safeguarding the health and safety of consumers, the licensor, by the approval of the Board, has the power to revoke a license or registration certification if there appears to be a subsequently incidents.

12) Chapter X - Appeals: In this section, Thailand government improves the appeal of medical device by the amendment that an establishment registrant, registrant, licensee or specifications provider whose establishment registration certificate, license or specification declaration certificate is suspended or revoked has the right to submit an appeal in writing to the Minister within thirty days as from the day of acquiring knowledge of the order.

13) Chapter XI - Civil Liability: In this section Thailand government doesn’t make any amendment.

14) Chapter XII - Penalties: In this section Thailand government improves the penalties of registration regulatory by the amendment of the penalties, for example any person who manufactures or imports medical device which is not in accordance with a license, declared specifications and registrant in violation of section 46(5) shall be liable to fine not exceeding two thousand baht.

15) Transitory Provisions: In this section Thailand government doesn’t make any amendment.

16) Schedule of Fees: In this section, Ministry Announcement regarding the schedule of fees is required in order to implement the Act.

 

References:

Medical Device Act (Issue 1and2) B.E. 2562 (2019)

Medical Device Act (Issue 1) B.E. 2562(2019)


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Thailand Medial Device Act (Issue 2) B.E. 2562

  

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Home About Qualtech NEWS THAILAND: ThaiFDA Issues the Amended Medical Device Act (Issue 2) B.E. 2562 (2019) – June, 2019