Certification of Single-Use Sterile Hypodermic Needles and Single-Use Sterile Dental Needles
On February 10, 2021, Inmetro published Ordinance No. 84, which approves the Conformity Assessment Requirements for Single-Use Sterile Hypodermic Needles and Single-Use Sterile Dental Needles, consolidating with other regulations that dealt with the same topic. This publication revokes Inmetro Ordinance No. 501, of December 29, 2011, and Annex A of Inmetro Ordinance No. 289, of September 4, 2020. This act is in line with Decree No. 10,139 of November 28, 2019.
This scope aims to establish the criteria and procedures for assessing the conformity of single-use sterile hypodermic needles and single-use sterile dental needles, under the Health Surveillance regime, with a focus on health, through the certification mechanism. Exclusions from the scope of these requirements are defined, through a specific normative act, by the Brazilian Health Regulatory Agency – Anvisa.
The following supplementary documents are also adopted:
It is possible to choose between two different certification models
Model 5 – Initial assessment consisting of tests on samples taken from the manufacturer, including an audit of the Quality Management System – SGQ, followed by a periodic maintenance assessment, through the collection of a sample of the product in the market, to conduct the evaluation activities of the compliance, and QMS audit.
Model 1b – Batch verification. Assessment of test results on random samples from the batch. No maintenance of certification.
See the certification process steps for Model 5
After requesting certification with our commercial department, a technical requirement (RT) is conducted that will define the necessary tests and the respective standards. Some laboratories in Brazil will be pointed out, so we will start the certification process.
After receiving the test reports, an assessment is conducted, and when necessary, we request corrections or changes in cases of audit nonconformity or test failures.
In the ultimate step, we will send you a preview of the certificate, and if approved, we will register your product in ProdCert, Inmetro’s product registration program.
Maintenance of certification is conducted every 12 months, with the collection of product samples in the market, for conducting tests and auditing the QMS.
The Certificate of Conformity is valid for five (5) years from the certificate issuance.
With recertification, a new cycle of conformity assessment begins.
Quality Management System Audit Process – QMS
Below are the audit requirements for quality management system following ABNT NBR ISO 13485 to be verified:
Documents control
Control of Records
Communication with the customer (ref. Handling Customer Complaints 7.2.3. C)
Acquisition process
Verification of Purchased Product
Production and Service Supply Control
Identification and Traceability
Product Preservation
Control of Measuring and Monitoring Devices
Customer feedback
Product Measurement and Monitoring
Nonconforming Product Control
Corrective Action
Preventive Action
Also, the handling of complaints established in the RGCP.
Definition of Sampling for collection and testing
The sample collection shall be conducted randomly in the production process of the product object of the request, provided that the product has already been inspected and released by the factory’s quality control, or in the shipping area, in packaging ready for commercialization.
For each hypodermic needle family, thirty-two (32) results of each test shall be generated. For this, NCC will collect one thousand, six hundred and thirty-two (1632) units for the first sample, six hundred and thirty-two (1632) units for the counter-sample, and six hundred and thirty-two (1632) units for the control sample, totaling four thousand, eight hundred and ninety-six (4896) units. Also, considering that twenty-five (25) units are necessary to generate one (1) result for the Limits test for acidity or alkalinity, plus twenty-five (25) units to generate one (1) result for the Limits test for metals extractable, and another one (1) unit to generate one (1) result for the other tests; fifty-one (51) units of hypodermic needles are needed to generate one (1) result for all tests.
For each dental needle family, thirty-two (32) results of each test shall be generated. For this, NCC will collect eight hundred and thirty-two (832) units for the first sample, eight hundred and thirty-two (832) units for the counter-sample, and eight hundred and thirty-two (832) units for the control sample, totaling two thousand, four hundred and ninety-six (2496) units.
Tests to be performed on single-use sterile hypodermic needles
Tests to be performed on single-use sterile dental needles
Estimated process time
This depends a lot on the communication between the customer and NCC, so it shall always be clear what the next steps are so that the process can proceed. If not clear, please ask us
Benefits of acquiring a certified needle and certifying a needle
Greater confidence – safety, quality, and assurance that the needle complies with current regulations;
Customer satisfaction – the needle performs as expected;
Social responsibility – by exposing the consumer to lower risk, it shows respect and responsibility towards society;
Adds value – a certified needle gives confidence to the consumer, valuing the brand and the manufacturer before the interested parties.
Non-certified products
The Brazilian Health Regulatory Agency – Anvisa is responsible for defining, through its own normative act, the compulsory certification of single-use sterile hypodermic needles and single-use sterile dental needles, as well as conducting Market Surveillance, verifying, among others, if the sold needles have active certification. All irregular products are withdrawn from sale, and those responsible are fined.
Still have questions? Contact us! We will be happy to help!
Material subject to amendment(s) in case of change in the ordinance(s). Published: 03.19.21