Thursday, 28 March 2024


MEDICAL DEVICES - The How To Guide

24 April 2014 | Regulatory | By BioSpectrum Bureau

Australia

MEDICAL device is any instrument, apparatus, appliance, material or any other article (whether used alone or in combination, and including the software necessary for its proper application) intended for use by the person under whose name it is to be supplied. These are used for the purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease. Conformity assessment is a series of procedures, which the manufacturers are obligated to meet, that check whether the medical devices measure up to the specifications of a relevant standard in order for them to be placed on the markets in regulated countries (eg: Australia, Europe, the US). Device electronic application lodgement (DEAL) is an online regulatory submission process for registering medical devices on ARTG. Australian register of therapeutic goods (ARTG). This is a list of therapeutic goods that have been included on the Register. Sponsor is responsible for import, export, or manufacturing medical devices.

Therapeutic Goods Administration

Australian manufacturer obtains a conformity assessment certificate from the TGA. Overseas manufacturer obtains an MRA/CE certificate and an Australian declaration of conformity. Manufacturer gives the appropriate conformity assessment certificate to the sponsor. Sponsor submits the certificate as the manufacturer's evidence through the DEAL system.

TGA reviews and accepts the submitted manufacturer's evidence. Sponsor submits medical device application through the DEAL system with the appropriate application fee. TGA accepts the application. TGA includes the device in the ARTG. Annual charges must be paid by the sponsor and post-market monitoring is conducted by the TGA.
www.tga.gov.au


India

MEDICAL device is any device intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals. The covering letter should clearly specify the intent of the application, duly signed and stamped by the authorized signatory, indicating the name and designation of the firm. Form 40 is as per the performa prescribed in the Drugs and Cosmetics Rules.

Central Drugs Standard Control Organization

Dossier including covering letter, authorization letter, wholesale license, free sale certificate, ISO 13485:2003 certificate, full quality assurance certificate, CE design examination certificate, declaration of conformity, inspection/audit report. An application for issue of a registration certificate shall be made to the licensing authority in Form 40, either by the manufacturer or by an authorized agent in India. Authorization by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a magistrate, or in the country of origin before such an equivalent authority. A fee of $1,500 shall be paid along with the application in Form 40 as registration fee for premises that are meant for manufacturing of drugs intended for import into and use in India. Applicant shall be liable for the payment of a fee of $5,000 for expenditure as may be required for inspection or visit of the manufacturing premises or drugs. A registration certificate, once received, shall be valid for a period of three years from the date of its issue. If the applicant does not receive the registration certificate within the period as specified he may appeal to the central government.
www.cdsco.nic.in

China

CHINA categorizes medical devices into passive and active devices. A passive device includes those for transportation and storage of pharmaceutical product, for alteration of blood and body fluids, for medical dressing and surgical equipment, implantable device, and those for contraception. Active device includes device of treatment through energy, for diagnostic monitoring, for ionized radiation and other general devices.

China FDA

Appoint a legal agent in China and get acceptation by CFDA. Determine the medical device classification as class I, II, III. Prepare testing product sample tested by medicine device testing center. All class III and class II medical devices need to undergo clinical trial except those similar products already registered by CFDA. Technical evaluation by Center of Medical Device Evaluation of CFDA. Final approval by CFDA. Obtain registration certificate. 
www.sfda.com

Singapore

CLASS A includes low risk products like surgical retractors/tongue depressors; class B includes Low-moderate risk products like hypodermic needles/suction equipment; class C includes moderate-high risk products like lung ventilator/bone fixation plate; and class D includes high risk products such as heart valves/implantable defibrillator.

Health Science Authority

Applications must be submitted online via medical device information and communication systems (MEDICS). Medical device dealers must be registered to accounting and corporate regulatory account. A CRIS (client registration and identification service) account is required for companies to access MEDICS. Once authorization has been, granted employees or service providers can access MEDICS using their SingPass or HSA PIN. Registration of class A medical device involves application process in four steps, including application submission, screening, review and regulatory decision by authority.

For class B, C, D category, product registration application must be prepared in accordance with ASEAN common submission dossier template (CSDT) in English and must be accompanied by all relevant certificates, reports and copies of labeling. A pre-submission consultation may be necessary if there are specific issues or when there is uncertainty as to whether the application dossier will meet the prevailing submission requirements. On evaluation of whether the authority determines a product to be 'registrable' the registrant may submit an application to list the medical device on the Singapore medical device register (SMDR). The registrant must comply by all post registration conditions laid by the authority. A key contact person appointed by the company would be the person, who will liaise with the authority on all issues regarding applications submitted by the company including input request on applications. Application must be accompanied by certificate of good distribution practice for medical devices in Singapore (GDPMDS) or ISO 13485 certificate, with scope of storage and distribution.
www.hsa.gov.sg

Taiwan

TFDA is responsible for the regulatory approval of medical devices. Center for drug evaluation, under the department of health, evaluates new drugs and new medical devices for regulatory requirements and offers consultation services to related parties. Regulatory framework for a medical device in Taiwan covers product classification, quality system and GMP manufacturing, registration of products, labelling control, commercial advertisement control, control of clinical investigation, adverse event reporting, and sales and distribution control. Medical devices are, by their functions, purpose, method of use and operational principles, divided into the following 17 categories. For regulatory administration purposes, medical devices are further classified into 3 classes by degree of risk to a human body, like, class 1: low risk, class 2: medium risk and class 3: high risk.

Taiwan Food and Drug Administration

Submission for class I device includes application form and a copy of pharmaceutical medical device manufacturer/distributor license. No quality system documentation is needed. Medical devices in different classes are subject to different levels of regulatory control for product registration. Class II requires quality system documentation registration and product registration with TFDA or certification with a third party. Class III requires quality system documentation registration and product registration with TFDA, clinical data. Submission for class II/III medical device license include medical device GMP, pre-market review of class II and class III devices, technical review of class II and IV devices, and approval and maintenance of medical device license.
www.fda.gov.tw

Malaysia

MEDICAL device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related articles intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes diagnosis, prevention, monitoring, treatment or alleviation of disease. Medical device is classified based on the risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device. It includes - class A (low), class B (low moderate), class C (high moderate), class D (high). MeDC@St is a web-based Online application system for establishment licensing, medical device registration and export permit. It is a centralized system where only one account needs to be created by an applicant to apply for establishment licensing, medical device registration or export permit.

Malaysia Medical Device Authority

Determine whether the product is a medical device and classification of medical device. Appoint conformity assessment body to conduct conformity assessment. Apply to register medical device using MeDC@St.
www.mdb.gov.my

South Korea

KFDA's medical devices and radiation health department undertakes inspection and quality assurance for medical devices, sets radiation standards, manages radiation safety control programs, and conducts research on medical devices.

Korea Food & Drug Administration

A medical device undergoes different regulatory pathways, depending on its classification. KFDA requires pre-market notification for class I devices and pre-market approval for class II and III devices. KFDA issues product licenses only to local firms. Class II or III devices require a documentary review of the technical file (registration dossier), as well as a local type test performed in Korea on samples imported with KFDA permission. Korean regulations require medical device importers to maintain certifications of compliance to quality management system (QMS) for imported devices from a KFDA-authorized entity that can issue such licenses. Once KFDA approves a medical device, every import shipment of a class II or III device must be tested locally before the products can be offered for sale. When clinical trials are required, foreign clinical studies is accepted in lieu of local trials when conducted according to Good Clinical Practices (GCP).
www.mfds.go.kr

Sign up for the editor pick and get articles like this delivered right to your inbox.

Editors Pick
+Country Code-Phone Number(xxx-xxxxxxx)


Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account