CDSCO Publishes List of Notified Bodies under MDR 2017

The Central Drugs Standard Control Organization (CDSCO) has released the updated list of Notified Bodies registered under the Medical Device Rules (MDR), 2017.

Certified Medical Device Testing Laboratories under MDR 2017

A list of Certified Medical Device Testing Laboratories (MDTLs) registered under MDR 2017 has also been published by CDSCO. These laboratories are authorized to conduct evaluations and testing of medical devices as per regulatory requirements.

Classification of Rehabilitation Medical Devices under MDR 2017

CDSCO has issued the classification of rehabilitation-related medical devices under MDR 2017, outlining device categories based on intended use, associated risk, and regulatory parameters to ensure compliance and safety.

Guidelines for Registration Review of Quantitative In Vitro Diagnostic Reagents

The National Medical Products Administration (NMPA) issued the “Guidelines for the Registration and Review of Analytical Performance Evaluation of Quantitative In Vitro Diagnostic Reagents” (2022 No. 32) to further standardize the management of IVD reagents for quantitative detection.

Filing Requirements for Class I Medical Devices

NMPA’s Announcement No. 62 (2022) provides detailed guidance on filing procedures for Class I medical devices and in vitro diagnostic reagents, based on the “Regulations on the Supervision and Administration of Medical Devices” and related administrative measures.

Updates to Trial Schemes for Accepting Overseas Marketing Approvals

The Medical Device Division (MDD) has announced revisions to trial schemes under the Medical Device Administrative Control System (MDACS), enabling acceptance of marketing approvals from China’s NMPA and South Korea’s MFDS. Updated forms are now available on the MDD website.

Updated Advisory on Paclitaxel-Coated Devices

Singapore’s Health Sciences Authority (HSA) has updated its advisory on paclitaxel-coated medical devices following a meta-analysis showing higher risks of amputation in patients treated with paclitaxel-coated balloons (PCBs).

Notification on Changes to Medical Device Technical Document Review Organizations

The Ministry of Food and Drug Safety (MFDS) has notified changes to the representatives of medical device technical document review institutions, in line with Article 15-2 of the Enforcement Rule of the Medical Device Act.

Guidelines on Facility Licensing and Violation Penalties

The Saudi Food and Drug Authority (SFDA) has issued two key guidelines: one on “Medical Devices and Supplies Facility Licensing Requirements (MDS-REQ9)” and another on the “Classification of Violations and Prescribed Penalties” under the medical devices regulatory framework.

Table of classification of violations and penalties prescribed for them according to the system of medical devices and supplies and its executive regulations

SFDA has published guideline on Table of classification of violations and penalties prescribed for them according to the system of medical devices and supplies and its executive regulations.

Updated Application for Priority Medical Device Determination

The Therapeutic Goods Administration (TGA) has updated its application form for priority applicant determination, simplifying the submission process for medical device manufacturers seeking expedited review.