Regulatory Updates

The QMSR builds on ISO 13485, but FDA-specific requirements still apply — plus an MDSAP roadmap and a self-check list.

Indonesia’s new software and AI medical device guidelines apply immediately, with local clinical validation for imported AI.

The UK will indefinitely recognise EU MDR / IVDR CE-marked devices — but UK local obligations remain.

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…

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…

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…

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…

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…