March 3, 2022 Regulatory Updates

Medical Devices- Asia Regulatory Updates Roundup, Feb 2022


Draft GSR 104(E)_Regulation of sale of medical devices via registration of premises under MDR, 2017

G.S.R. 104(E).—The following draft of certain rules further to amend Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to public.

Notice: Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017

Classification of Medical Devices Pertaining to General Hospital/Orthopaedic Instruments

For Updated List of medical devices please check the link below


MDA publishes guidance on refurbished medical devices

This guidance document specifies requirements for refurbished medical devices to be place in the Malaysian market.


Guidelines for Compilation of Technical Requirements for Medical Device Products (No. 8 of 2022)

In order to improve the normative and scientific nature of the technical review of medical devices, and to guide the registrant/filer of medical devices in the preparation of product technical requirements, according to the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for Medical Device Registration and Filing, and the In Vitro Diagnostic Reagents Registration and Filing Management Regulations.


Safety measure Notice (medical equipment) – Occurrence of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL) in Patients Implanted with a Gel-filled Breast Implant or Tissue Expander, and Information Provision to the Patients (Request for Information Dissemination)

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared updated information on breast implant safety after professional bodies announced two new cases of a rare cancer linked to the devices.

In the past, PMDA has worked with regional officials to share information on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) prepared by professional bodies. Late last week, the agency again called for the commissioners of cities with health centers to help disseminate updated information about the risk of BIA-ALCL.

The update comes after reports of the third and fourth reported cases of the blood cancer in Japan. Both patients had received “an unapproved gel-filled breast implant,” according to PMDA.

PMDA wants to disseminate the update to reach people in Japan who have undergone, or are considering undergoing, breast reconstruction with a gel-filled breast implant. The materials encourage regular medical examination and self-examination to enable the detection of the disease.


MDS-G002 Guidance on Innovative Medical Devices

The purpose of this guidance is to define the designation criteria for Innovative Medical Devices, to outline the requirements for applying through the Innovative Medical Devices Pathway, and to explain the submission process. The guidance applies to the innovators, developers, manufacturers, and authorized representatives of Innovative Medical Devices.


Information for medical practitioners on up-classification of surgical mesh devices

Purpose of this guidance

This guidance is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1 December 2021.

Supply disruption may be the result of some sponsors not able to demonstrate they meet Australian regulatory requirements for safety, quality, and performance for these types of devices.

For more information, please find the link below.

Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia

The TGA sought feedback on a Discussion paper on potential changes to mandatory reporting of medical device adverse events.

For more information, please find the link below.

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