16 September 2020
FOOD AND DRUG ADMINISTRATION ANNOUNCEMENT
TECHNICAL DOCUMENTS PREPARATION FOR INSPECTION PURPOSE 2020
To ensure that medical devices are qualified accordingly to their efficiency and safety standards on account of medical device end-users.
By virtue of Section 41 (9) of the Medical Device Act B.E. 2551 (2008) as amended by the Medical Devices Act (No. 2), B.E. 2561 (2019) Secretary-General of the Committee Food and Drug Administration, therefore, issued the following announcement:
1. Establishment Importer Licensee, Licensed Medical Device Licensee, Notified Medical Device Licensee, or General Medical Device Licensee shall prepare technical documents for inspection purpose to verify that medical devices meet its quality, efficiency, and safety.
2. Technical documents preparation for inspection purposes can be prepared in documents or electronic documents format in Thai or English at the place of Manufacturing or Importation accordingly.
3. Establishment Importer Licensee, Licensed Medical Device Licensee, Notified Medical Device Licensee, or General Medical Device Licensee shall submit technical documents.
(1) On-site Inspection (Must comply with ThaiFDA on-site inspection by providing technical documents at presence)
(2) Appointed for Inspection via phone call (Must comply ThaiFDA appointed inspection by providing technical documents upon the informed timeframe)
4. After cessation of sale, technical documents shall still be kept ensuring medical devices are qualified accordingly to their efficiency and safety standard. For medical devices with no expiry date, technical documents shall be kept at least 5 years after the manufactured date. For medical devices with expiry date shall be kept for 1 year from the expiry date.
5. Technical documents preparation details shall be prepared accordingly to the table below. If technical documents do not meet authority inspection purposes, the Licensor shall have the power to request further documents.
6. Technical Documents Preparation timeline is as follow:
(1) Classification 1, 2, and 3 as defined in Ministry of Public Health, Classification Rule of Medical Device, shall come into force as after the 270 days of its publication in Government Gazette or on June 13, 2021
(2) Classification 4 as defined in Ministry of Public Health, Classification Rule of Medical Device, shall come into force after the 360 days of its publication in Government Gazette or on September 11, 2021.
Technical Documents Preparation Details:
References:
1. Food and Drug Administration Announcement regarding Technical Documents Preparation for Inspection Purpose 2020
2. Guidance for Food and Drug Administration Announcement regarding Technical Documents preparation for inspection purpose 2020