Tanzania Medicines and Medical Devices Authority (TMDA), the country’s agency responsible for healthcare products, has published a draft regulation prescribing the rules and procedures for laboratory analysis of medical and non-medical products.

The new draft regulation covers such aspects as:
– Engagement of a laboratory to conduct analysis,
– General aspects of collaboration with a laboratory,
– Disposal of samples and waste,
– Solving disputes regarding results of analysis,
– Functions of laboratory technical committees,
– Dealing with conflicts of interest,
– Training and accreditation,
– Data protection and confidentiality,
– International cooperation in the sphere.

Regulatory Background

The new Regulation suggested by the TMDA shall become the main act regulating relationships arising with regard to laboratory analysis of both regulated and non-regulated products, including medical devices, which are intended to be marketed and used in the country. First, the Regulation provides the definitions of the most important terms used in the context of laboratory analysis, namely: 

  • Accreditation – formal recognition of a laboratory by the Authority in relation to the competence of the laboratory to conform to specified standards; 
  • Analyst blinding – the process by which an analyst is kept unaware of the identity of a sample allocated to him for analysis to avoid results bias;
  • Commercial samples – samples submitted by the customer for testing purposes that do not form part of marketing authorization;
  • Non-medical products – all products that do not meet the definition of a medicine, medical device, or diagnostics as set out in the Regulation;
  • Post-marketing surveillance program – a program for sampling and testing selected medical products to assess their quality after marketing authorization.

According to the draft regulation, the Authority is entitled to carry out laboratory analysis for the products described herein. In particular, the Authority may receive samples for analysis both in the course of premarket review and also for separate assessment on a commercial basis. It is important to mention that the Authority also has a right to outsource some of its functions in the sphere of laboratory testing if needed. The Authority can also provide training and perform accreditation. 

Laboratory Analysis Regulations in Detail

Depending on the type, all the samples could be divided into:

  • Port of entry samples,
  • Registration samples, 
  • Inspection samples,
  • Post-marketing surveillance samples,
  • Controlled drug samples,
  • Commercial samples,
  • Any other samples as it may be required. 

Further, the document describes the most important aspects associated with each type of sample. In particular, the Regulation outlines certain types of products for which the samples should be collected at ports of entry due to high risks associated with such products. For such products, the appropriate quality testing should be performed. Should the samples collected at ports of entry fail to pass the laboratory testing, such products should be re-exported or disposed. Moreover, if three different batches fail to pass testing, the product, in general, should be re-exported or disposed.  

Registration samples are those submitted by interested entities applying for marketing authorization for their products in Tanzania. 

The Authority is also entitled to collect inspection samples in the course of inspections it carries out in accordance with its powers and responsibilities. Under the general rules, samples could be subject to preliminary screening using portable equipment. The results of the screening could later be confirmed by testing conducted in a laboratory environment if the Authority finds it reasonably necessary. Should the products fail to pass such testing, they could be subject to recalls. The same approach applies to the samples collected in the course of post-marketing surveillance activities. 

The document also provides the list of sample types the TMDA laboratories are allowed to test on a commercial basis upon requests from industry representatives and other interested parties. 

Testing Process

Each time they provide samples for testing, the interested party shall also provide the laboratory with:
  • Request form in which the particular parameters subject to testing should be indicated,
  • Samples themselves,
  • Fees payable for analysis in accordance with the applicable regulations. 
The number of units to be provided depends on the nature of the medical device or other product submitted for testing. The Authority additionally emphasis the remaining shelf life should be at least three months at the date they are being submitted for testing to a laboratory. However, the manufacturer could be requested to provide additional samples which are closer to the expiration date. 
All the samples should be provided in original containers in order to exclude the impact of external factors. Each sample received by the Authority is subject to recording in a special register.
As mentioned, one of the most important concepts related to laboratory testing is “analyst blinding” – according to the Regulation, the analyst performing testing should not be aware of the manufacturer of the medical device or other products subject to review in order to avoid testing bias. This principle ensures that testing is conducted in an impartial and unbiased manner, and its results will be reliable accordingly. During the testing itself, the laboratory shall use the appropriate testing methods validated for the particular type of testing. 

Engagement of Third-Party Laboratories

According to the draft regulation, the TMDA is also entitled to outsource some of the testing functions to third-party laboratories. In this regard, the Authority will consider the following: 
  • Accreditation and prequalification status of the laboratory,
  • Completion of an audit carried out by the Authority before,
  • Desk review in the light of regulatory requirements for quality management system employed, and 
  • Costs associated with testing to be performed. 
Once the Authority identifies the particular third-party laboratories to work with, it will conclude the appropriate contracts with them prior to commencing any activity. It is important to mention that the terms of such a contract are to be determined by the Authority itself. 
In case of engagement of a third party laboratory, the Authority will be responsible for ensuring that the delivery of samples will be performed in the correct way. Once the testing is completed, the Authority will review the results provided and issue the appropriate certificate. It is also important to mention that it is the Authority that will be the party responsible for testing results provided by such a third party laboratory engaged in testing. 

Dispute Resolution

The TMDA acknowledges that in certain cases, disputes may arise with regard to laboratory testing results. The new draft regulation also prescribes the way such disputes should be handled. According to the document, a customer may submit objections in the form of a written notice within 14 days from the date a laboratory has provided the results. In such a case, the Authority will conduct an additional review in order to ensure the accuracy of the results and appropriate application of testing methods. Once completed, the author will notify a customer about the results of the additional review. A customer may also request testing to be conducted in the presence of a witness, together with the representative of a customer. In certain cases, an alternative laboratory could be enraged as well.

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.