Medical Devices-Asia and ROW Regulatory News-Feb 2023

CHINA (CFMDE-NMPA)

Announcement of the State Food and Drug Administration on Issuing YY/T 1888-2023 “Recombinant Humanized Collagen” Medical Device Industry Standard (2023 No. 14) 

The Center for medical device evaluation of china has issued a Standard. YY/T 1888-2023 “Recombinant Humanized Collagen” medical device industry standard has been approved and is now published.

The document specifies the quality control, technical requirements, test methods, stability, biological evaluation, packaging, transportation and storage of recombinant humanized collagen. This document is applicable to the quality control of recombinant humanized collagen that does not contain the amino acid sequence of non-human collagen as raw material for medical devices.

PHILIPPINES (FDA)

FDA Circular No.2023-002 – Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities

FDA Circular No. 2020-035 included provisions in the conduct of alternative arrangements and virtual inspections for continuous government service delivery while ensuring the safety of both its clients and regulatory officers. The conduct of on-line and virtual inspections are one of the risk-mitigating measures established by FDA in line with the goals of Republic Act.

The Department of Health (DOH), through the issuance of Administrative Order (AO) No. 2020-0035 or the “Rules and Regulations on the Licensing and Registration of Radiation Facilities Involved in the Use of Radiation Devices and Issuance of Other Related Authorizations,” provided an updated, re-engineered, and streamlined regulatory guideline in the authorization of radiation facilities, repealing DOH AO No. 124 s. 1992 or the “Rules and Regulations Governing the Establishment, Operation and Maintenance of an X-ray Facility in the Philippines.”

MALAYSIA (MDA)

MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION

This guidance specifies requirement for registration of medical gas system “placed in market” as defined in Medical Device Act 2012.

This Guidance explains about Medical gases are used for healthcare purposes in different ways. Some are used for treatment, some for anaesthesia, and some for driving medical devices and tools. The medical gas system (MGS) is an essential part of any healthcare facility, a failure of which can contribute to the morbidity and/or death of the patient.

It is essential that all elements such as the design, manufacturing and installation of MGS intended to be placed in Malaysian market shall meet the standards of safety, quality and performance as per the guidance. Section 5(1) of Medical Device Act 2012 (Act 737) requires that a medical device is registered under the Act before it can be imported, exported or placed in the market. This guidance document is made pursuant to Section 5 of Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. Only devices that comply with these requirements may be placed in the Malaysian market.

PANAMA (MINSA)

Resolution No.001 – Regulation of Medical Devices Provision

The ministry of health Republic of panama has released guidelines for the storage and distribution of medical devices and related products and adopts the Form called Good Practices for Storage and Distribution of Medical Devices and Related Products.

All applications for operating license procedures for manufacturing, conditioning, distribution, and warehouse establishments must contain documentation of the Compliance with the Guidelines for the storage and distribution of MEDICAL DEVICES and end products, as a requirement for their evaluation.

The details regarding the storage and distribution practices of medical devices and related products are defined in the document 

BAHRAIN (NHRA)

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

The main Subject this circular about 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.
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.  

SAUDI ARABIA (SFDA)

National Diagnostic Reference Levels

The purpose is to introduce the national references in order to identify and establish the National Diagnostic Reference Levels (NDRLs) for different diagnostic ionizing radiation applications, as well as to clarify the SFDA’s requirements in applying these references. These references protect patients from medical radiation doses that may exceed the approved limits and levels, which may be unjustified, without affecting the image’s quality and its diagnostic characteristics.

This national reference is applied to radiology department that have the following imaging modalities:

• Computed Tomography (CT) devices.
• General X-Ray devices.
• Mammography devices.
• All Medical Devices modified or developed within Healthcare facility

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

The purpose of this document is to define and clarify the requirements for manufacturing medical devices at Points of Care (POC). 

This 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.