Malta Medical Device Registration

Navigating Malta’s Medical Device Regulations: Insights from Malta Medicines Authority

Regulatory Authority

Malta Medicine Authority

The Malta Medicines Authority’s mission is to regulate medical products and pharmaceutical activities for human use, ensuring public health. It performs duties, advises the Licensing Authority, and monitors clinical trials. It provides high-quality monitoring and inspection services, enforces legislation, and enhances the use of medical products. The authority manages scientific research, supports cannabis regulation, and participates in European fora.

Link for Regulatory Authority

http://www.medicinesauthority.gov.mt/mdlegislation?l=1

Local Regulation

• EU MDR
• Maltese Legislation
• Medical devices regulations 21st March 2010

https://medicinesauthority.gov.mt/mdlegislation

Link for guidance documents

https://medicinesauthority.gov.mt/mdguidance

Classification of Medical Device

Class I, IIa, IIb and III

Listing or Registration Requirements

Manufacturer or AR placed in Malta must notify the authority. 

Documents Required

1. Certified copy of the registration certificate or other official document / normative document certifying the establishment of the requesting unit and the ascertaining certificate issued by the registry office trade from which the object of activity of the company results, for the requesting units that have the obligation to register at the trade register office the establishment of the requesting unit.
2. The EC declaration of conformity of the manufacturer provided in Annex no. 7 to the Government Decision 54/2009, with the subsequent amendments.
3. The declaration of conformity provided in annex no. 8 to the Government Decision 54/2009, with the subsequent modifications ÿ the declaration of conformity provided in art.29 of the Government Decision No 54/2009, with subsequent amendments.
4. A list of the components of the system or package of procedures, together with the EC declaration of conformity of the manufacturer for each component.
5. Technical specification
6. Instructions for use of the medical device
7. Medical device label
8. The declaration of conformity provided in annex no. 6 to the Government Decision 55/2009, with subsequent amendments
9. The document by which the manufacturer designates you as an authorized representative.
10. Copy of the certificate of conformity issued by a notified body 

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device. 

Registration Fee

• Initial Registration of Distributor / Importer – € 500
• Notification fee per device (renewable annually) – €15
• Application Form for MDRP (renewable annually) – €100

https://medicinesauthority.gov.mt/productfees 

License Validity

5 Years

Special Labelling Requirements

The information on the label must be in Maltese and/or English

Additional Comments

On April 5, 2017, new regulations for medical devices, MDR and IVDR, replaced the existing Directives. These underwent transitional periods, fully applying in May 2020 (MDR) and May 2022 (IVDR). Manufacturers and EU Authorized Representatives in Malta must register their business and device descriptions with the Regulatory Affairs Directorate. 

While specific data on Class IIa, IIb, and III devices may be requested when put into service, requirements depend on the device’s classification and risk. Remember, this summary is a starting point. For the most accurate and updated information, always consult official sources like the Malta Medicines Authority and EU regulations.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication? 

Before placing a medical device into the market.

Market overview

Anticipated to achieve US$67.51 million in 2024, the projected revenue in Malta’s Medical Technology market is led by the Medical Devices segment, expected to reach US$56.72 million. With an estimated annual growth rate of 4.11% (CAGR 2024-2028), the industry is poised to reach a market volume of US$79.31 million by 2028. 

In a global context, the United States is forecasted to generate the highest revenue, reaching US$215.80 billion in 2024. Malta’s medical technology market is witnessing rapid growth, particularly emphasizing innovative solutions tailored for advancements in the healthcare sector.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk