China has taken a major step forward in strengthening its medical device regulatory framework. On 7 November 2025, the National Medical Products Administration (NMPA) officially released the revised Good Manufacturing Practice for Medical Devices (GMP), replacing the decade-old version issued in 2014. The new GMP will come into full effect on 1 November 2026 , giving the industry one year to transition. This revision marks a significant shift toward globalised standards, en

China’s National Medical Products Administration (NMPA) released two draft announcements for public consultation on September 25, 2025 , outlining plans to expand the Unique Device Identification (UDI) system to nearly all classes of medical devices. This proposed expansion marks a significant step in China’s ongoing effort to enhance post-market surveillance, traceability, and regulatory transparency within the medical device sector. Strengthening Device Traceability and Pa

On 5 September 2025, the National Medical Products Administration (NMPA) announced an update to the Medical Device Classification...

On 28 July 2025, the National Medical Products Administration (NMPA) officially issued two new information standards that will come into...

The National Medical Products Administration (NMPA) has officially issued the updated Announcement No. 45 of 2024, introducing six...

With the exponential rise of e-commerce in healthcare, China is taking significant steps to safeguard patient and product integrity...

The recent adjustment to the “Announcement of the State Drug Administration on Matters Related to the Production of Imported Medical...

Effective on the issuance date, 26 January 2025, the National Medical Products Administration (NMPA) has started implementing “Several...

The National Certification and Accreditation Administration (CNCA) recently announced changes to the national standards for wire...

The State Drug Administration of China has released an important update aimed at strengthening the quality management of pharmaceutical...

To enforce the Drug Administration Law of the People’s Republic of China and the Vaccine Administration Law of the People’s Republic of...

The National Institutes for Food and Drug Control (NIFDC) formulated three new technical documents to facilitate the industry in cosmetic...

On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products...

As part of the initiative to boost foreign investments in the pharmaceutical industry and improve high-quality drug developments and...

China Clinical Requirements Update On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical...

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Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...

Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...

China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...