A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

India Implements Code of Conduct for Medical Device Marketing

/in , /by

October 10, 2024: India medical device marketing now adheres to strict ethical guidelines under the DoP’s Uniform Code.

Read more

Singapore Issues Guidance on Change Management for SaMD

/in , /by

Singapore’s SaMD Change Management Program (CMP) is a new regulatory framework for streamlining software update approvals with the HSA.

Read more

China to Enact Medical Device Law

/in , /by

On August 28, 2024, China released a draft of the medical device law for public comment on significant regulatory changes.

Read more

Vietnam Allows Amendments to Registration Applications Under Review

/in , /by

On August 16th, 2024, Vietnam MoH introduced new guidance allowing amendments to registration applications under review, enabling document updates during the process.

Read more

Vietnam Clearing Backlog of Medical Device Registration Applications

/in , /by

Survey of the Vietnam Ministry of Health (MoH) database on May 9, 2024, showed a significant rise in Class C/D medical device processing.

Read more

Vietnam MoH Audits License Holders for Compliance

/in , /by

Asia Actual Vietnam completed an MoH audit, covering key compliance areas including licensing, documentation, and operational procedures.

Read more

India Changes Medical Device Application Processing System

/in , /by

On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.

Read more

India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses

/in , /by

India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.

Read more

Thailand Adds Qualified Personnel Requirements for Establishment Licensing

/in , /by

Thailand’s Ministry of Public Health issued a new notification affecting medical device establishment licensing and controller qualifications

Read more

Philippines Incentivizes Local Medical Device Manufacturing

/in , /by

July 31st, 2024: Philippines established its first inaugural Pharma-Med Development Hub, which will contribute to local medical development.

Read more