Regulatory Updates

EVERBIZ | EU MDR/IVDR Regulatory Update On 28 May 2026, the first four modules of the European database on medical devices, EUDAMED, became mandatory. Many companies breathed a sigh of relief after registering their new products, but it is easy to overlook the second milestone that follows – 28 November 2026: the deadline for registering existing devices. As of 14…

The new medical device GMP inspection guidelines take effect on 1 November, with 200 inspection items graded at three levels. Here are the key points.

A medical device warehouse in Cleveland is open for shared use, with a lead-shielded room and initial importer services available.

From 18 October, Class A devices containing animal components must hold a halal certificate.

The HSA has introduced a premarket submission checklist, fully enforced from 1 January 2027. EVERBIZ summarizes the key points and what to do.

To enter the EU market, cosmetics must be notified in the CPNP before they are placed on the market. In this issue, EVERBIZ covers four things: what it is, who notifies, how to notify and what to prepare. What Is the CPNP? The CPNP (Cosmetic Products Notification Portal) is the EU’s online notification system for cosmetics, under Article 13 of…

In August this year, police raided a warehouse in Bang Phli, Bangkok, after a tip-off that many online shops were selling cosmetics and supplements without Thai labels or approval. The inventory included more than 83,000 items imported from Japan alone, worth over THB 8.34 million. The warehouse had originally been a transit point for imported goods, but gradually became a…

On 20 April 2026, the EU Medical Device Coordination Group (MDCG) updated its classification guidance, officially MDCG 2021-24 Rev.1. This is the first revision since the guidance was published in 2021, and on the same day the product nomenclature and a supply-disruption decision table were also updated. Officially, the update “mainly clarifies and makes no major changes”. But for some…

Many medical device companies preparing to enter the six ASEAN markets (Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines) first hear the term “CSDT” at the submission stage. It appears in almost every ASEAN member state’s technical documentation guidance, yet few people explain its background clearly. This article covers the CSDT in full – from its legal status and internal…

Overview | In 2026, Singapore’s Health Sciences Authority (HSA) continued to update its guidance on medical device product registration, change notification, IVD grouping, dealer licensing and cybersecurity. For companies planning to enter Singapore or already holding SMDR registrations, the choice of registration route, document version control and post-market change management all need to be adjusted accordingly. In recent years Singapore…

On 11 September 2026, the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (the “Hague Apostille Convention”) enters into force for Vietnam, making Vietnam the 129th contracting party. For Chinese companies pursuing medical device registration and market access in Vietnam, this is not just diplomatic news but a compliance speed-up that directly affects “how soon company documents can…

On 19 February 2026, the US Food and Drug Administration (FDA) published in the Federal Register the latest revision of its list of FDA Recognized Consensus Standards, “Recognition List Number: 065” (List 065). The update took effect on publication, adding 31 standards and revising more than 75, an important adjustment to the standards used in premarket review of medical devices.…