Medical Devices-Asia and ROW Regulatory News-Jan 2023

INDIA (CDSCO)

Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer

In order to enhance the testing capacity of medical device in the country identification registration & empanelment of government private testing laboratory for Medical Devices testing is under consideration as per MDR 2017.

In this regard, laboratories which have capacity for testing of medical device & are NABL accredited are requested to submit the application in Form MD-39 along with requisite fees and documents, through online portal www.cdscomdonline.qov.in., for taking further necessary action in the matter.

CHINA (CFMDE-NMPA)

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the “Guidelines for the Registration and Review of Single-Use Epidural Anesthesia Catheters” (No. 45, 2022) 

In order to further standardize the management of single-use epidural anesthesia catheters, the Center for Device Evaluation of the State Food and Drug Administration organized the formulation of the “Guidelines for the Registration and Review of Single-use Epidural Anesthesia Catheters”, which are hereby released.

Attachment: Guidelines for Registration Review of Single-Use Epidural Anesthesia Catheters

HONG KONG (MDD-DOH)

Listed Rapid Antigen Tests for COVID-19 under MDACS 

The Medical Device Division (MDD) has granted listing approval for the following rapid antigen tests for COVID-19. All the listed devices meet the listing requirements of Medical Device Administrative Control System (MDACS) on safety, quality and performance. Department of Health also monitors the safety alerts issued by oversea regulatory authorities and manufacturers, and handles adverse events associated with devices listed under MDACS.

Details of listed rapid antigen tests for COVID-19 can be found in The List of Medical Devices.

New Procurement Requirement of the Department of Health for Medical Devices

A pilot run of a new requirement on the procurement of Medical Devices (MD) by the Department of Health (DH) has been implemented with effect from 1st Oct 2022. Under the pilot run, certain MD (including, condoms, lubricants of Class II or above*, auditory evoked potential system, blood glucose meter and blood glucose strip) being purchased for use in the Services of DH should preferably be listed under the Medical Device Administrative Control System (MDACS). Subject to the experience gained from the pilot run, DH will include more MD into the scheme.

Traders who are interested to submit bid/ quotation/ tender for the supply of the above MD for DH Services are encouraged to apply their relevant MD for listing under the MDACS as soon as possible. If you are interested to apply your MD for listing under the MDACS.

Update of the Post-Market Surveillance (PMS) Reporting Form for Certain Medical Devices 

The post-launch monitoring report form for certain medical devices has been updated. The local responsible person can use the above form to report on the monitoring of specific medical devices after they are launched on the market. The form number is now fixed as MD108 and can be found on the Medical Devices Division.

MALAYSIA (MDA)

GUIDELINE DOCUMENT ON HOW TO SUBMIT AN APPLICATION FOR REGISTRATION OF A REFURBISHED MEDICAL DEVICE 

This guideline specifies requirements and application process to register the refurbished medical devices. It covers all registered or unregistered medical devices that are intended to be refurbished.

In accordance with this recommendation, refurbished medical equipment must be registered via the Medical Device Centralised Online Application System (MeDC@St). The manufacturer or the authorised representative is in charge of registering a refurbished medical device.

Exclusion: This document’s guidelines do not apply to the remanufacturing of medical devices.

GUIDELINE FOR DRUG-MEDICAL DEVICE AND MEDICAL DEVICE-DRUG COMBINATION PRODUCTS

Combination product: A product comprised of two or more regulated components, i.e., drug/device, biological/device, or drug/device/biological, that are physically, chemically, or otherwise combined or mixed and produced as a single entity or Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products.

Registration Process of Combination Products

The primary agency for registration of combination product is based on the primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved:

Medical device does not achieve its primary mode of action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; shall be regulated by MDA.

REGISTRATION OF COVID-19 TEST KITS THAT HAVE BEEN APPLIED VIA CONDITIONAL APPROVAL AND SPECIAL ACCESS

MDA would like to inform that all Conditional Approval and Special Access for COVID-19 test kits have been halted and future placement of COVID-19 test kits on the market shall be subjected to their registration under section 5 of the Medical Device Act 2012 (Act 737). Application to register the test shall be made online via our Medical Device Centralized Online Application System (MeDC@St).

With this arrangement, all COVID-19 test kits that have completed evaluation at the testing facilities and passed the set performance criteria shall proceed for registration via MeDC@St. Please refer to the relevant reference documents, namely MDA/GL/MD-01, MDA/GL/IVD-1, MDA/GL/07 and MDA/GD/0059 to get further information on the requirements and procedure for the registration of COVID-19 test kits.

SAUDI ARABIA (SFDA)

MDS – G009 – Guidance for Points of Care (POC) Medical Devices Manufacturing 

This Guidance applies to healthcare providers wishing to manufacture medical devices within their facilities for their own use and for non-industrial scale (with regard to the magnitude and methods of production).

This Guidance document applies to the following activities:

1. Manufacturing of medical devices using 3D printer inside a healthcare facility.
2. Manufacturing according to the Medical Device Production System (MDPS).
3. In-House IVD.
4. All Medical Devices modified or developed within Healthcare facility.

MDS – G010 – Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices

The purpose of this guidance is to clarify the requirements for obtaining Medical Devices Marketing Authorization (MDMA) for Artificial Intelligence (AI) and Machine Learning (ML) based medical devices, in order to place them on the market within KSA.

This guidance applies to Artificial Intelligence (AI) and Machine Learning (ML) technologies that diagnose, manage or predict diseases by analyzing medical data.

BAHRAIN (NHRA)

Circular No. (02) 2023: To All Medical Devices Importers- Authorized Representatives Scope verification with the Imported Shipments

The National Health Regulatory Authority would like to announce the initiation of scope verification for authorized representatives with the scope of importation shipments as part of the importation applications review process.

As a result, any importation shipment that is not within the authorized representative’s registered scope will not be approved.

Importers can contact Medical Device Regulations department via Medical_Devices@nhra.bh email for any inquiries. Authorized representatives who intend to add or modify the scope registered in their license can apply online through AJHEZA system.