Medical Devices-Asia and ROW Regulatory News-Jan 2023

INDIA (CDSCO)

Registration of Medical Device Testing Laboratories (Form MD‑40)

To strengthen national medical device testing capacity, CDSCO is considering the registration and empanelment of government and private laboratories under MDR 2017. Laboratories with the capability to test medical devices and holding NABL accreditation are invited to submit Form MD‑39, along with required fees and documents, through the online portal (www.cdscomdonline.gov.in) for further assessment.

CHINA (CFMDE–NMPA)

Guideline for Single‑Use Epidural Anesthesia Catheters

The Center for Medical Device Evaluation (CMDE) has released the “Guidelines for the Registration and Review of Single‑Use Epidural Anesthesia Catheters” (No. 45‑2022). The document aims to standardize regulatory review and strengthen oversight of these devices.

HONG KONG (MDD–DOH)

Listed COVID‑19 Rapid Antigen Tests under MDACS

The Medical Device Division has granted listing approval for several rapid antigen test kits for COVID‑19. All listed products comply with MDACS requirements for safety, performance, and quality. DOH continues to track international safety alerts and monitors adverse events for devices listed under MDACS.

New Procurement Requirements by the Department of Health

A pilot program that began on 1 October 2022 introduces a new procurement requirement: selected medical devices (e.g., condoms, Class II lubricants, blood glucose meters/strips, auditory evoked potential systems) should preferably be MDACS‑listed when procured for DH services. Depending on pilot outcomes, additional device categories may be included. Traders are encouraged to seek MDACS listing before submitting bids.

Updated Post‑Market Surveillance Reporting Form

The PMS reporting form for selected devices has been revised. Local responsible persons must now use Form MD108 to report post‑market monitoring activities. The updated form is available on the Medical Device Division website.

MALAYSIA (MDA)

Guideline for Registration of Refurbished Medical Devices

MDA has published guidance outlining the requirements and procedures for registering refurbished medical devices. The process applies to both registered and unregistered devices intended for refurbishment. Applications must be submitted through MeDC@St by the manufacturer or authorized representative. The guideline does not apply to remanufactured devices.

Guideline for Drug–Medical Device and Device–Drug Combination Products

Combination products consist of two or more regulated components (drug/device/biologic) marketed as a single product or packaged together. Regulatory responsibility depends on the product’s primary mode of action. Products primarily functioning as medical devices—i.e., not acting mainly via pharmacological, immunological, or metabolic means—fall under MDA oversight.

Registration of COVID‑19 Test Kits After Conditional or Special Access Approval

MDA has ended conditional and special access pathways for COVID‑19 test kits. Future market placement requires full registration under Section 5 of the Medical Device Act 2012 (Act 737), submitted through MeDC@St. Test kits that successfully complete performance evaluation should proceed with formal registration. Relevant reference documents include MDA/GL/MD‑01, MDA/GL/IVD‑1, MDA/GL/07, and MDA/GD/0059.

SAUDI ARABIA (SFDA)

MDS‑G009 – Guidance for Point‑of‑Care Device Manufacturing

This guidance applies to healthcare facilities manufacturing medical devices for in‑house use on a non‑industrial scale. It covers:

• Devices manufactured using 3D printing 
• Devices produced under the Medical Device Production System (MDPS) 
• In‑house IVDs 
• Any devices modified or developed within healthcare institutions
• MDS‑G010 – Guidance for AI/ML‑Based Medical Devices

SFDA issued guidance describing requirements for obtaining MDMA authorization for artificial intelligence and machine‑learning–based medical devices intended for disease prediction, diagnosis, or management. The document clarifies essential data, performance expectations, and regulatory standards for market placement in Saudi Arabia.

BAHRAIN (NHRA)

Circular No. 02/2023 – Scope Verification of Authorized Representatives

NHRA has introduced scope verification for authorized representatives as part of the review of medical device import applications. Import shipments outside the representative’s approved scope will not be accepted. Importers may contact the Medical Device Regulation Department at Medical_Devices@nhra.bh for inquiries. Representatives seeking to update their licensed scope may apply via the AJHEZA system.

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.