Medical Devices-Asia and ROW Regulatory News-Sep. 2023

ASIA

INDIA (CDSCO)

India puts regulations that facilitate R&D at heart of new policy on pharma and medtech

India’s Department of Pharmaceuticals (DoP) has released the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector in India. In the document, DoP identifies the need for a regulatory environment that “facilitates innovation and research in product development.”

Indian officials are concerned about “the relatively low pace of development of biologics, biosimilars and other emerging products/trends” and see the innovation policy as a way to “help enhance domestic availability and affordability of these categories of new age therapeutics.” The concern informed the decision to make enabling “rapid drug discovery and development and innovation in medical devices by streamlining of regulatory processes” the first objective of the policy.

DoP sees changes to the regulatory environment as a way to facilitate its other objectives. The policy names regulatory complexity as a barrier to private investment in innovation, a core goal, and discusses the need to develop a “talent ecosystem” that creates a medical device workforce that includes people with “knowledge of navigating regulatory policies.”

MALAYSIA (MDA)

Placement of HIV Self-Test (HIVST) Kit in Malaysia Market

World Health Organization (WHO) has introduced HIV self-testing as an approach to reach people who may not test otherwise, including people from key populations, men and young people3. HIV self-testing could be done by introducing HIV self-test (HIVST) kits in the in-vitro diagnostic market. This emerging technology could be used as an effective method for controlling HIV risk transmission, which could later help initiate the Pre-exposure prophylaxis (PrEP) programme for the high-risk infected person.

This document is written to guide the establishment on both pre-market, placement on the market and post-market requirements including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labelling, advertising and distribution and post-market surveillance and vigilance activities.

Draft – Public Comment First Edition Guidance Document: Importation of Medical Device for Re-Export (IRE)

This guidance document applies to all products that fall within the definition of medical device, as defined in MDA/GD/0001: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices.

This guidance document is intended to provide requirements and notification process for applicant such as established company in Malaysia, licensed establishment or forwarding agent to obtain permission from the Authority for import for re-export medical devices for the purposes of maintenance, testing, sterilization, packaging, labelling, distribution hub or other purposes specified by the applicant and intends not to be placed in the Malaysian market.

Upon issuance of IRE approval letter, the applicant allows to import medical devices to Malaysia through international courier or accompanied with passengers through various modes of transportation by land, sea or air.

Public Comment First Edition Guidance Document: Wearable Medical Device

The guidance document to determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical Device Act 2012 (Act 737).

This guidance document excludes the products that are intended for general wellness and do not have medical claims.

This guidance document is applicable to the establishments that are dealing with wearable medical devices.

Announcement: Medical Device Authority (MDA) Circular Letter Number 1/2023: Permission to Place in the Market Self-Test Kits for Human Immunodeficiency Virus Disease (HIV)

The authorization of the placement of HIV self-testing kits (HIVST) in the market was approved by the MDA Members’ Meeting on the 15th. March, 2023 and its implementation is effective from the 14th. August, 2023 which is in line with the publication of Circular Letter of the Director General of Health Malaysia No. 14/2023 and the publication of the document Guidelines for the Implementation of HIV Self-Screening Tests in Malaysia by the Disease Control Division, Ministry of Health.

Guidelines by the MDA regarding the placement of HIV self-testing kits (HIVST) in the market are in the final stages of development and will be published by the 25th. August, 2023 as a reference and establishment guide for registering HIVST medical devices.

CHINA (NMPA)

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on Issuing the Guiding Principles for the Registration and Review of the Clinical Evaluation of the Same Type of Electronic Endoscope (No. 35, 2023)

Electronic endoscopes have been included in the “Catalogue of Medical Devices Exempted from Clinical Evaluation (2021)” (referred to as the “Catalogue”), such as electronic upper gastrointestinal endoscopes. This guideline is formulated based on the “Technical Guidelines for Clinical Evaluation of Medical Devices” (hereinafter referred to as “General Rules”) and combined with the characteristics of electronic endoscopes.

This guideline does not apply to products such as capsule endoscopes. The clinical evaluation of ultrasound electronic endoscopes can refer to the applicable parts of this guideline, but the evaluation of ultrasound technical characteristics also needs to be considered.

The clinical evaluation method defined in this guideline is based on the framework and basis of the general principles and is based on the technical review requirements for comparison of electronic endoscopes of the same type.

Notice from the Device Review Center of the State Food and Drug Administration on the release of guiding principles for clinical evaluation registration review of soft contact lenses (No. 33, 2023)

This guideline applies to single-focus daily wear soft contact lenses (hereinafter referred to as soft contact lenses) that adopt the principle of optical correction for the purpose of correcting myopia, hyperopia and astigmatism. They can be colored or not. The common materials are hydrogel, Silicone hydrogel and other materials. The product classification code is 16-06-01, and the management category is Category III. Excludes continuous wear, bifocal, multifocal or graduated focal soft contact lenses.

Soft contact lenses belong to the third category of medical devices with high risks for clinical use mentioned in the “Technical Guidelines for Decision-making Whether to Conduct Clinical Trials of Medical Devices”.

Announcement of the State Food and Drug Administration on Adjusting Some Contents of the “Medical Device Classification Catalog” (2023 No. 101)

In order to further deepen the reform of the medical device review and approval system, based on the actual development and regulatory work of the medical device industry, and in accordance with the relevant requirements of the “Regulations on the Supervision and Administration of Medical Devices” and the “Working Procedures for Dynamic Adjustment of Medical Device Classification Catalogs”, the State Food and Drug Administration has decided to Some contents of the “Device Classification Catalog” have been adjusted.

The content of the “Medical Device Classification Catalog” involved in 58 categories of medical devices has been adjusted.

Announcement of the State Food and Drug Administration on the release of 4 information standards including the “Basic Data Set for Medical Device Registration and Filing Management”

This document specifies the data set classification, data item description, medical device registration management data subset and filing management data subset involved in medical device and in vitro diagnostic reagent registration and filing management.

This document specifies the identifier, Chinese name, short name, definition, data type, representation format, allowed value, measurement unit, version and source of data elements related to the registration and filing of medical devices (including in vitro diagnostic reagents) in drug regulatory information. This document specifies the data element value field codes for the registration and filing information of medical devices (including in vitro diagnostic reagents) in drug regulatory information. This document applies to the representation, exchange, identification and processing of information related to medical devices (including in vitro diagnostic reagents) in the field of drug supervision.

Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of Artificial Intelligence Software for Magnetic Resonance Imaging Systems (No. 36, 2023)

This review point applies to magnetic resonance (MR) imaging systems using artificial intelligence (AI) technology. According to the currently effective “Medical Device Classification Catalog”, the classification code of this type of product is 06-09, and the management category is Class III.

The AI software functions referred to in this review point must run on the MR system and be registered with the MR system as a software component. Some AI software functions are presented in the form of dedicated independent software that runs on the general computing platform (workstation, etc.) of the MR system. If it is registered with the MR system as an accessory, it can be regarded as a software component of the MR system.

Notice on publicly soliciting opinions on two industry standards including the “Quality and Technical Specifications for Clinical Trials of Medical Devices”

This standard covers the entire process of pre-market clinical trials of medical devices, including the design, implementation, monitoring and auditing of medical device clinical trials. Check, inspect and collect, record, save, analyze, summarize and report data, etc.

This standard defines the protocol design, implementation, and implementation of clinical trials conducted to evaluate the clinical performance and safety of in vitro diagnostic (IVD) reagents. Quality and technical specifications for monitoring, auditing, inspection, and data collection, recording, preservation, analysis, summary, and reporting.

The purpose of clinical trials is to evaluate the use of in vitro diagnostic reagents by intended users in the intended use environment, and to target the acquisition and acceptance of the target population.

Notice on the public solicitation of opinions on “Guiding Principles for Registration Review of Absorbable Internal Fixation Implants Part 1: Synthetic Polymer Materials (Draft for Comments)”

This guideline applies to Class III implantable medical devices made of absorbable synthetic polymer materials that are expected to perform bone-to-bone or bone-to-soft tissue fixation. The product is made of absorbable synthetic polymer materials such as homopolymers, copolymers or blends of lactide, glycolide, trimethylene carbonate, and ε-caprolactone. It may also be made of the above synthetic polymers. The material is made of a composite material mixed with inorganic materials such as hydroxyapatite, beta-tricalcium phosphate, and calcium sulfate.

This guideline does not apply to intraosseous fixation implant devices made of absorbable natural polymer materials and degradable metal materials. This guideline does not apply to orthopedic filling and restorative materials.

SINGAPORE (HSA)

GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices Revision 4

For medical device to be supplied in Singapore, it must conform to the Essential Principles of safety and performance for medical device. Medical device dealers in Singapore are responsible to ensure that the relevant Essential principles of safety and performance are met, making reference to internationally recognized standards or equivalent.

The document provided an overview on meeting the essential principles of safety and performance of medical device. All medical devices supplied in Singapore, regardless of whether the respective medical device require registration or has an exception from product registration requirements, are require to conform to the essential principles for safety and performance.

GN-05-R3 Guidance on the Reporting of Adverse Events Revision 3

The Authority uses a number of post marketing risk assessment measures to ensure the continued safe use of medical devices. These measures include reporting from healthcare professionals, consumers or patients, mandatory reporting from medical device dealers and exchange of regulatory information with other medical device regulatory agencies.

The document is applicable to all persons who register, manufacture, import and supply medical devices in Singapore. Persons who register, manufacture, import and supply medical devices in Singapore shall also be referred to as dealers of medical devices in the document.

GN-07-R3 Guidance on Complaint Handling  Revision 3

An effective compliant handling system is an important part of any quality system. Any compliant received on a medical device should be evaluated and if necessary thoroughly investigated and analysed and corrective actions should be taken.

The document is applicable to all persons who register, manufacture, import and supply by wholesale medical devices in Singapore.
Complaints cornering death and serious injuries should be reported to the authority in accordance to mandatory reporting timelines stipulated in medical devices Regulation 2010. 

GN-33 R2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices Revision 4

The company should develop a quality management system that conforms to the requirements of SS GDPMDS and demonstrate its ability to maintain the quality and integrity of medical devices throughout the supply chain.

SS GDPMDS is applicable to importers wholesalers and outsourced service providers dealing with medical devices in Singapore. The guidance illustrates some approaches which an organization may follow in order to implement and maintain a quality management system hat conforms to the requirements of SS GDPMDS.

ROW

MEXICO (COFEPRIS)

Mexico accepts other countries’ GMPs to facilitate import of biologics; claims doubling of device approvals

Citing the need to improve access to vital medicines, COFEPRIS is allowing foreign makers of biologics sold in Mexico to forego obtaining a Certificate of Good Manufacturing Practices (GMP) from the agency before their products can be released in the country. Instead, as of 23 August, they may present GMPs issued by other health authorities accredited by the World Health Organization (WHO), PAHO, or members of the Pharmaceutical Inspections Cooperation Scheme (PIC/S) in lieu of a COFEPRIS certificate.

The new rule is intended to complement ongoing efforts by COFEPRIS, announced earlier this month, to promote local manufacturing of biologic and biosimilar products, according to a statement from the agency. Together, “these actions are an important step to ensure that Mexicans have access to safe, effective, and high-quality biotechnological and biosimilar medicines, and reinforce the health authority’s commitment to the health of the entire population,” the statement said. Days earlier, in a separate announcement, the agency said it had authorized 1,588 new medical devices in 2023, representing an increase of some 125% from 2022 and an 88% approval rate.

In 2023, Cofepris Doubles Authorizations for New Medical Devices

Mexico City, August 20, 2023.- The Federal Commission for the Protection against Sanitary Risks (Cofepris) carries out robust and specific efforts to expedite the attention to authorizations and procedures regarding medical devices**, which are beneficial of the health and quality of life of the population.

So far in 2023, 3,285 health registration procedures have been attended, of which 1,588 new medical devices have been authorized, that is, 125 percent more authorizations than the same period in 2022; Two thousand 937 procedures for modifications to the health registration conditions and more than three thousand 450 extension procedures have been attended, so it is projected that the attention to procedures will more than double by the end of the year. It is important to note that 88 percent of the procedures handled have been approved.

AUSTRALIA (TGA)

Varying entries in the ARTG Medical Devices and IVD Medical Devices

The guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.

It is important that the information included in the ARTG is kept up-to-date and is correct from a public health, regulatory and transparency point of view. When any information included in the ARTG has changed, the sponsor should consider if they need to request the TGA to vary the respective ARTG entry.

If you want to correct an ARTG entry that is incomplete or incorrect, you will need to apply to the TGA under subsection 9D (1) of the Therapeutic Goods Act 1989 by submitting either a Variation to Class III/AIMD, IVD Variation or Device Change Request (DCR) application.

Changes that may require variation of an ARTG entry:

• Information entered on the ARTG is not complete or correct
• Manufacturer’s details (e.g. name or address) have changed
• Change of GMDN code by the manufacturer to a more relevant, active, or preferred code
• Change to the intended purpose of the device by the manufacturer (e.g. broadening or reducing clinical indications)
• Manufacturer has added or removed product variants
• Total number of devices has changed (increased or decreased)
• Manufacturer changed the Unique Product Identifier (UPI)
• Sponsor wants to vary the list of IVD devices included in the ARTG entry

There is no legislated timeframe for the evaluation of an application to vary an ARTG

Application for TGA Conformity Assessment Certificates (Medical Devices)

The TGA uses a number of identifiers to track various elements of the conformity assessment application process

This document provides guidance on how to apply for a TGA conformity assessment certificate.

Reclassification of active Medical Devices for Therapy with a Diagnostic Function

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Requirements for reclassification

The requirements include:

• More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
• Conformity assessment documents demonstrating procedures appropriate for a Class III device
• Mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

Reclassification of Medical Devices in direct contact with the Heart, Central Circulatory and Central Nervous Systems

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Reclassification of medical devices that administer medicines or biologicals by inhalation

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb). 

Reclassification of Medical Devices that are Substances to be introduced into the Body or Applied to and Absorbed by the Skin

This guidance aims to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

This guidance is specific to medical devices that are composed of substances or of combinations of substances that are intended to be introduced into the body via a body orifice or applied to and absorbed by the skin.

Reclassification of Spinal Implantable Medical Devices

The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.

From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:

• More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
• Conformity assessment documents demonstrating procedures appropriate for their classification
• A mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

The classification of spinal implantable medical device will determine the safety and performance requirements to be demonstrated to meet regulatory requirements.

Active Medical Devices

Active medical devices are a subset of devices that use energy to operate and converts energy in a significant way. For a device to be an active device, the form of energy does not include gravitational or directly provided human energies. This document includes guidance on the requirements that specifically apply to these devices.

Regulation of Software Based Medical Devices

The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply.

This is a guide only, and manufacturers and sponsors are encouraged to familiarize themselves with the legislative and regulatory requirements in Australia, and if necessary, to seek professional advice. It is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.