Zambia medical device regulations

ZAMRA's recall guideline, dated March 2023 on its cover and stated to be a cross-product instrument: its scope covers medicines and allied substances, and devices fall in through the Act's definition of "allied substances". It sets the recall classes and levels, the steps of the recall procedure, notification of a quality problem or defect, initiation and risk evaluation, assessment and recall strategy, the roles and responsibilities of each stakeholder (ZAMRA, the marketing authorisation holder, wholesalers, health facilities, retail outlets, health professionals and the public), effectiveness checks, reinstatement of supply and penalties. Five appendices are ingested with it, including the reporting form, the customer reply form and the post-recall report form. Note that the copy's own table of contents carries several "Error! Bookmark not defined." placeholders where page numbers failed to generate — a defect of the source, ingested as published.

ZAMRA/MA/GUD/0002, the device classification guideline, and the instrument that states Zambia's four-class system and its classification rules. It adapts the GHTF classification document: its cover states "Version 1" with "Date of implementation 2018", while the running footer on every page carries "November 2nd, 2012" — the date of the GHTF document it derives from, not of the ZAMRA document. All nineteen rules are ingested as their own `rule` blocks so an individual rule can be cited, and two decision-tree appendices are ingested with them.

ZAMRA/MA/GUD/0001, the essential-principles guideline, and the substantive safety-and-performance standard a Zambian device application is assessed against. It follows the IMDRF GRRP WG/N47 FINAL: 2018 structure: the principles applicable to all devices and IVDs, then the principles applicable to devices other than IVDs, then those applicable to IVDs. It cites IMDRF/GRRP WG/N040:2017 in its references, and the running footer carries "31 October 2018". Two appendices are ingested with it (use of standards in meeting the essential principles, and guidance on the essential principles).

ZAMRA/MA/GUD/0003, the IVD marketing-authorisation guideline, and the IVD counterpart to the non-IVD guideline. It runs from the general requirements and the application through screening, evaluation, laboratory analysis and GMP inspection to the grant, validity, amendment and renewal of an IVD marketing authorisation, with the IVD classification rules and the application compilation at 1.14 and 1.15. One thing about the copy is recorded rather than repaired: its own cover version-history block states "Version 2 published for implementation" with no date, while the running footer on every page reads "V 1.0". The version stated here is the footer's, which is the one the document repeats on every page and the one the round-207 registry row carries.

ZAMRA/MA/GUD/0005, the labelling guideline, setting the label and instructions-for-use content separately for devices other than IVDs and for IVDs. It adapts the GHTF labelling document: the running footer carries "September 16th, 2011", the date of the GHTF source rather than of the ZAMRA document, and the copy states no ZAMRA implementation date. A reference to the consolidated ZAMRA labelling requirements is what a Zambian registration submission is screened against.

Zambia's medicines and allied substances statute: assented to on 21 March 2013 and enacted on 22 March 2013, continuing the Pharmaceutical Regulatory Authority as the Zambia Medicines Regulatory Authority, and providing for the registration of medicines and allied substances, licensing, manufacture, import and export, and the control of pharmacies. Device relevance is in the definitions and in Part VII: "allied substances" is defined to include "medical and surgical sundries, medical devices and condoms", which is the hook ZAMRA uses to regulate devices and the hook its GUD-series guidelines cite. Section 65 is the device-safety offence (selling a medical device that may cause injury to the user), and section 69 is the regulation-making power under which the subsidiary instruments are made. Ingested in full — all 70 sections and 11 Parts. Its arrangement page and the Part titles set in a decorative face extract as letter-salad from the source PDF; the section text itself extracts cleanly and is ingested as published.

The core ZAMRA device marketing-authorisation guideline and this market's lead instrument. Its cover version history reads "Version 1 draft 21st May, 2021 / Version 1 released for comment 17th September, 2021 / Version 2 published for implementation 21st June, 2024"; the copy states no ZAMRA document number, so the version and date are what identify it. It sets the general requirements on the applicant and the dossier, the product information, the classification of a non-IVD device, and the technical information required for each class, and it carries the application form and the product-dossier checklist as annexes (ANNEX I with Parts I to III, ANNEX II, Annex III and Annex IV, which is ZAMRA's 1.xx-numbered dossier item index). It is the instrument that states the device marketing-authorisation requirement in Zambia today.

The transitional renewal guideline for marketing authorisations issued before 2015, made under section 39 of the Medicines and Allied Substances Act and Statutory Instrument No. 79 of 2019. Its cover version history reads "Draft Zero December 2019 / Version 1 draft December 2019 / Version 2 / Date of implementation December 2019"; the copy states no ZAMRA document number. It sets the general, administrative and technical requirements for a renewal submission and carries the application forms and the key-product-information template as its annexes. ZAMRA states on its face that it will issue a separate guideline for products registered from 1 January 2015 onwards, so this document is scoped to the pre-2015 cohort and should be read as such. It is ingested as `form-instructions` because what it principally contains is the completion requirements for a prescribed form.