Medical Devices – Asia Regulatory Updates Roundup, Apr 2022

Draft Rules: India proposes waiving BSE certificates if materials come from negligible risk countries

India has proposed changing its Medical Device Rules, 2017 to waive the need for companies to share certain transmissible disease certificates when sourcing animal products from negligible-risk countries.

Medical devices that use tissues or derivatives from animals that can carry transmissible spongiform encephalopathies (TSE) or bovine spongiform encephalopathy (BSE) pose a potential risk to humans. That risk has led regulators around the world to impose safeguards since the risk came to light. India is now proposing to selectively lift one of its safeguards.

DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country

This guidance document is aimed to provide requirements, procedures and practices for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS),Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, bio chemic and Chinese products) and their raw materials.

This document is applicable for import and export of therapeutic goods for commercial and non-commercial purposes

Notice of the Center for Device Review of the State Food and Drug Administration on Issuing the Guidelines for the Registration Review of Extracorporeal Membrane Oxygenation (ECMO) Devices (No. 19, 2022)

In order to further standardize the management of extracorporeal membrane oxygenation (ECMO) equipment, the Center for Device Review of the State Food and Drug Administration organized and formulated the “Guidelines for the Registration and Review of Extracorporeal Membrane Oxygenation (ECMO) Equipment”, which are hereby issued.

Notice of the General Department of the State Food and Drug Administration on the establishment of the “Recombinant Humanized Collagen” medical device industry standard

In order to encourage the research and development and innovation of new biomaterials of recombinant humanized collagen and promote the high-quality development of the medical device industry, combined with the needs of industrial development and supervision, the State Food and Drug Administration approved the “Recombinant Human Collagen”. Sourced Collagen” medical device industry standard formulation and revision project was established.

Circular of the Center for Device Review of the State Food and Drug Administration on Issuing 3 Guidelines for Registration Review of Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Reagents (No. 18, 2022)

In order to further standardize the management of new coronavirus-related detection reagents, the Center for Device Review of the State Food and Drug Administration has organized the formulation of the “Guidelines for the Registration and Review of Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Reagents” and “New Coronavirus (2019-nCoV) Antibody Detection”. Guidelines for Reagent Registration Review and Guidelines for Registration Review of Novel Coronavirus (2019-nCoV) Antigen Detection Reagents are hereby released.

Notice of the Center for Device Review of the State Food and Drug Administration on Issuing the Guidelines for the Registration Review of High-Strength and Toughness Pure Titanium Orthopedic Internal Fixation Implants (No. 14, 2022)

In order to further standardize the management of high-strength and toughness pure titanium orthopaedic internal fixation implants, the Device Review Center of the State Food and Drug Administration organized the formulation of the “Guidelines for the Registration and Review of High-strength and toughness pure titanium orthopaedic internal fixation implants”, which are hereby issued.

Draft Medical Device Guidance Document Requirements for Labelling Of Medical Devices

Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft requirements for the labeling of medical devices. The fifth edition of the guidance features changes to the rules on the general contents of labeling and to other sections of the text.

The ISO 14971standard addresses the application of risk management to medical devices. MDA’s proposal covers information such as the instructions for use, any postmarket servicing needs of the device, and any undesirable side effects, limitations or warnings.

Draft Medical Device Guidance Document Change Notification for Registered Medical Device

Malaysia’s Medical Device Authority (MDA) is seeking feedback on change notification guidance. The draft defines three categories of changes to registered medical devices and what they mean for affected companies.

MDA splits postmarket changes into three categories. Companies can implement category 3 changes immediately, although they still need to submit a request to MDA before taking action. The other two categories cover more substantive changes. Category 2 changes need MDA evaluation and endorsement prior to implementation. Category 1 changes require new registration because they affect the safety and performance of the medical device.

Innovative medical device designation notice (No. 19)

In accordance with Article 21 of the Medical Device Industry Promotion and Innovative Medical Device Support Act and Article 15 of the Enforcement Decree of the same Act, it has been designated as an innovative medical device and announced as attached.

Partial amendment to the Medical Device Act Enforcement Regulations (Ministry of Food and Drug Safety Notice No. 2022-180)

Reason for revision: In accordance with the revision of the Medical Device Act (Act No. 18319, partial revision on July 20, 2021, enforcement on July 21, 2022) due to mandatory medical device liability insurance, the necessary matters for its implementation are set, and administrative sanctions aggravated disposition standards This is to improve and supplement some deficiencies in the operation of the current system, such as clarifying the point of view.

In vitro diagnostic medical device clinical performance testing institution inspection plan and inspection target/schedule notification in 2022

The inspection plan for the in vitro diagnostic medical device clinical performance testing institution for the year 022 and the inspection target/schedule are announced as attached materials, so please refer to the clinical performance test management and inspection preparation work.

MDS-G002 Guidance on Innovative Medical Device

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.

This guidance applies to the innovators, developers, manufacturers, and authorized representatives of Innovative Medical Devices.