• 2020-05-06 01:48:16

Pharmaceutical drugs in India will now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.

• 2020-05-06 01:40:30

CMDE has made the necessary adjustments to pave way for a faster process in obtaining clinical trial approval. Prior to these changes, the applicant shall wait for CMDE’s go signal before starting the clinical trial procedure. With this change, the applicant may already start conducting the clinical trial, given some conditions.

• 2020-05-05 07:31:28

Registration of both local and foreign-manufactured medical devices in Malaysia is generally a two-part process. They are mainly regulated by the Medical Device Authority (MDA) of Malaysia, a local regulation and authorization body.

• 2020-05-06 05:39:48

HSA constantly improves the quality of guidance documents with the periodical revision of the same. Just recently, HSA made minor revisions for GN-02 and GN-15.

• 2020-05-06 05:29:23

HSA has conducted an industry briefing last March 28, 2019 regarding the guidance revision for Change Notification (CN) which aims to address typical concerns that results in confusion among stakeholders. Additional updates on the requirements for CN applications were also added.

• 2020-05-06 01:39:35

A team of Qualtech managers and regulatory specialists participated in the OMETA Seminar in Indonesia last month from March 05 to March 08.

• 2020-05-05 09:53:48

The Indian government has issued draft Quality Control Orders (QCOs) for medical electrical equipment, sphygmomanometers, clinical electrical thermometers, blood glucose monitoring system, gloves and surgical blades, to better ensure their safety and effectiveness.

• 2020-05-05 09:22:34

Seeking for the public comment for 3 three months, ThaiFDA amended “the Draft of the Product Containing Alcohol for Humans and Animals Sterilization” on several points, including the scope of the guideline, the verification report and labelling etc.

• 2020-05-05 09:19:30

As security attacks and threats brought by outside connectivity are on the rise, Health authorities from Asian countries have started taking necessary measures to protect the public. Here's an overview of the current situation of Cyber-regulations in Asia

• 2020-05-05 08:05:23

HSA requires Class A devices to be listed in SMDR database prior to importation and selling in Singapore. GN-22 includes this list of Class A medical devices of which an item was recently revised by HSA.