Jamaica Medical Device Regulation

Comprehensive Guide to Medical Device Registration in Jamaica: PRA, Regulations, and Market Insights

 Updated on 26/01/24

Regulatory Authority: Pharmaceutical and Regulatory Affairs (PRA)

Link for Regulatory Authority:https://www.moh.gov.jm/

Local Regulation: Food and Drugs Act 1964

Classification:

Listing or Registration Requirements:

Submit your application through the Ministry of Health (MOH) online using the MOH Trade System to the Pharmaceutical and Regulatory Affairs (PRA) department.

Approval is required for products regulated under the Food and Drugs Act, 1964 and Precursor Chemicals Act, 2005 before they can be imported into the country. Before importation, the customer should fill out the appropriate application form and pay the application fee. Permission to import is granted only if the product being requested has been reviewed and approved for importation before sale or use in Jamaica.

Documents Required for Registration:

• Three copies of a summarized statement (not package insert) giving information on the following where applicable:

1. All ingredients present in the device and their concentration
2. Instructions for use
3. Therapeutic/diagnostic claims/intended use
4. Patient population for which the device is intended
5. Description of the device, including components
6. Functioning principle (diagrammatic representation of the mechanism of action)
7. Physical and performance characteristics (device design, material used and physical properties)
8. Contraindications/precautions;
9. Adverse effects and complications
10. Toxic effects and protocol for treating toxicity
11. Performance tests

• Details of the tests conducted to control the potency, purity, and stability.Stability data with shelf-life conclusion will be required.
• Summary of:

1. Effectiveness: controlled studies; uncontrolled studies;
2. Safety: adverse reactions in volunteers and where the device has been marketed for less than five (5) years, adverse reactions in patients.

• A Certificate of Analysis (original, not photocopy) or a certified report containing:
• Assay report on a recent batch of the product analyzed; including specifications.
• Two (2) copies of the method of analysis used.
• Three (3) copies of a draft of every label bearing the name and address of themanufacturer proposed to be used in connection with the product, a batch/lotnumber, date of manufacture, storage conditions (including temperature) and expiry date of the product.
• Three (3) samples of the device in the finished form in which it is to be sold and/or biological reference standards of active ingredients necessary to perform analyses described above.
• Manufacturing processes and the quality assurance programme designed to assure and verify the quality of the process used to manufacture the device. This should include the methods used in and controls used for the design, manufacture, packaging, labelling and storage of the device.
• A “Certificate of Good Manufacturing Practice” providing information on the facilities and operations as recommended by the World Health Organization.
• The Premarket Approval (original, not photocopy) bearing information asrecommended by World Health Organization from the competent health authority in the country of manufacturer certifying that the device is approved for use in that country and the conditions under which it may be sold in that country.
• Package insert for physicians which provides information on the risks of thedevice, instructions for use and age indication.
• Information brochure for patients which includes short-term as well aslong-term risks.

• A statement showing:

1. The countries in which the product is approved for sale other than the country in which it is manufactured.
2. Any country in which use of the product has been refused and the reasons for refusal.

 Registration Timeline:Products submitted for registration should be on the market in the country
of manufacture or export for at least one (1) year prior to submission.

Special Labelling Requirements:The labelling submitted must be in the English Languageor authenticated translation.

Who should make this communication:

• Manufacturer
• Authorised representative

When to make this communication: Before placing a medical device into the market.

Market overview:
The projected revenue for Jamaica’s Other Medical Devices market is expected to reach US$49.70 million in 2024, with an anticipated annual growth rate of 4.67% from 2024 to 2028, reaching a market volume of US$59.66 million by 2028. In contrast, the United States is forecasted to lead in revenue, expected to generate US$73,490.00 million in 2024. The growth of Jamaica’s Other Medical Devices market is fueled by a rising demand for innovative medical devices in the country.

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