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A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 30th Year of Publication
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Global Market

Preparing For Global Markets :

Classification of your device - The starting point

Mr. Amit Dave,
M. Pharm, MBA,
Former CEO - Brazil Operations/ Vice President Export – Zydus Cadila/Claris Lifesciences

Understanding and classifying your device correctly is the first step for going ahead for overseas registration, as you know.

In this article, we will see how various Regulatory Authorities are classifying Medical Devices in their countries. Countries selected are mentioned in alphabetical order. Based on this information, we are sure you would be clear about where your devices fall. The next steps will go according to this classification though there are some common steps also, going across classes of devices. There are some fine differences in the classes in countries though they look almost similar, and sometimes, one can argue out his case with the authorities if there is sufficient ground to discuss and prove. In most of the cases, the descriptions are straightforward, however, and do not generate any disputes.

Algeria

Algeria is the largest country in African subcontinent (and the next is Congo). Public health in Algeria is free of cost to the citizens.

 

DPM (Direction de la Pharmacy et du Medicament) which is covered under the Ministry of Health and Population (MOHP) is responsible for Medical Devices registration.

 

Classification Of Medical Device in Algeria

Class I: Low Risk (Example: Simple Surgical Instruments)
Class IIa: Moderate-Risk (Example: Catheters, Infusion Pumps, Powered Wheelchairs)
Class IIb: Moderate-To High-Risk (Example: Dialyzers, Orthopaedic Implants)
Class III: High-Risk (Example: Coronary Stents)

Australia

TGA, The Therapeutic Goods Administration is the regulatory authority here. TGA covers the mainland of the Australian continent, the island of Tasmania and many smaller islands.

Classification Of Medical Device in Australia is also based on the risk to patients or to public health.

Class A: Low Risk
Class B: Low Moderate-Risk
Class C: Moderate-High Risk
Class D: High-Risk

Brazil

As the readers know, Brazil is the largest in Latin America, and represents almost 50% of South American subcontinent. Also, Brazil is the largest medical devices market in south America. ANVISA (Agência Nacional de Vigilância Sanitária) regulates registration of medical devices in Brazil. The systems of ANVISA are highly complex, one must note, though ANVISA is stating that theu=y are working on simplification. ANVISA is controlled by the Ministry of Health through a complex system. Often, Brazil is seen to follow European style and regulations rather than American norms.

Classification of devices in ANVISA is :

Class I: Low Risk (Non-invasive Medical Devices)
Class II: Medium Risk (Invasive Medical Devices)
Class III: High Risk (Active Medical Devices)
Class IV: Very high risk (Special Rules)

Ireland

Growth of medical devices in Ireland is somewhat low. HPRA (Health Products Regulatory Authority) is the regulatory authority in Ireland.

Classification Of Medical Device in Ireland:

Class I: Low Risk
Class IIa: Medium Risk
Class IIb: Higher Risk
Class III: Highest Risk

South Africa

In South Africa, SAHPRA, South Africa health products Regulatory Authority is the agency responsible for Medical Devices registration. Class A devices, below, are exempted from the licensing requirements though it will be better to have their registration done.

Classification Of Medical Device in South Africa:

Class A: Low Risk
Class B: Low Moderate-Risk
Class C: High Moderate-Risk
Class D: High Risk

Thailand

Medical Device Control Division (MDCD) falling under their Food and Drug Administration is looking after Medical Devices registration.

Classification Of Medical Device in Thailand

Class I: Low Risk
Class II: Medium Risk
Class III: High Risk (like Syringes, Contact Lens, Surgical Gloves, IVDs)

Please see that gloves are considered high risk. This is an example where country-wise definitions of classes differ.

Our readers are encouraged to compare these classes with the Indian classification of Class A (Low Risk), Class B (Moderate- Risk), Class C (Moderate-To High-Risk) and Class D: High-Risk.

Once the category / class of the product under review is clear, the next steps become easier..

 
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