Thailand Food and Drug Administration (TFDA) revised the medical device regulations in terms of the classification of the medical device,...

The Indonesian Ministry of Health urges the relevant License Holders to monitor regularly and report on the compliance of standard...

Based on the amendment made for the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023, Egyptian...

Due to the amendment of Paragraph 8 of Article 16 in Product Safety and Technical Regulations Law, No. 7223, the Turkish Medicines and...

HSA announced that 1 August 2023 will be the commencement date for Phase 2 of the voluntary notification for the Health Supplement (HS)...

MHRA released updates on the guidance of the legislation file for the in-vitro diagnostic (IVD) medical devices. There are 2 additional...

On 16 June 2023, the Ministry of Health of the Republic of Indonesia (KEMKES) announced the application of the CPAKB certificate as the...

ASEAN Cosmetic Committee has agreed to revise few materials stated in Annex II, III, VI, and VII after the 36th and 37th virtual meeting....

Starting from 1 July 2023, all shipments containing pharmaceutical products from India to The Gambia, are required to undergo...

On 14 July 2023, MDA announced the Covid-19 test kit evaluation during the emergency/pandemic will be shifted to the registration phase...

All non-registrant importers or non-authorized importers will need to apply for importation approval before importing registered...

Referring to EU Directives 90/385/EEC and 93/42/EEC, the Medical Device Authority (MDA) recognizes the EC Certificate as an approval type...

HSA revises the regulatory requirement and process for Therapeutic Products Registration and updates the guidance for the industry. As of...

Thailand FDA prepared a systematic CONCISE method to assist with medical device registration submission. The CONCISE method is expected...

The Drug Regulatory Authority of Pakistan (DRAP) revised the data requirement needed for the application of extending permission on drug...

National Pharmaceutical Regulatory Agency (NPRA) notified all product registration holders (PRH) to act on the addendum of the warning...

On June 20, 2023, the Therapeutic Goods Administration (TGA) released new requirements guidance to help manufacturers adopt the annulment...

The Cosmetic Product Regulation was published on 8 May 2023 by the Turkish Medicines and Medical Devices Agency (TITCK) with the purpose...

The Department of Health (DH) announced the implementation of a new requirement for medical devices procurement will be effective from 21...

In the previous blog, the Medicines and Healthcare products Regulatory Agency (MHRA) proposed for timeline extension for CE-marked...