The Medical Device Control Division, Thai FDA has been recognized by WHO as a reference agency, which allows Thailand to participate in the Collaborative Registration Procedure (CRP) program, that can shorten the duration of registration. The Thai FDA will assess the performance and safety of the medical device in cooperation
Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION. This guidance document will serve as a revised version of MDA/GD/0057 that was released in June 2020, which provides information on the requirements for registration of medical gas system “placed
On 11 January 2023, the Medical Device Authority (MDA) of Malaysia released the Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products. The revised guideline document covers the following matters : Revision on Changes/Variation to Particulars of a Registered Combination Product. Revision of Post-Marketing Activities: Management of
On January 11 2023, the MDA has announced the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10). This guidance document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with
The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2022-2045 on 29 December 2022, to warn all Prescription Pharmaceutical Products and Medical Devices (PPPMD) companies, and healthcare professionals (HCPs) not to engage in unethical business practices as mentioned in the provisions of Administrative Order (AO) No. 2015-0053 entitled
On 09 December 2022, the Thai FDA issued a clarification on the Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, that has become effective on 03 December 2022. With this new regulation, all physical therapy products will be classified as either Class A, B
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