The new article highlights the aspects related to the application of the reliance approach in the context of marketing authorization for medical devices.
Table of Contents
The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the reliance mechanism in regulatory processes, i.e., the authority’s approach to Good Reliance Practice. In particular, the document describes how the regulatory decisions taken by foreign national regulating authorities could be taken into consideration by DRAP when making its decisions with respect to healthcare products intended to be marketed and used in Pakistan. The guidance provides an overview of the existing regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance document and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Marketing Authorization of Medical Devices: Key Points
Under the general rule, registration of medical devices intended to be marketed and used in the country is governed by the Medical Devices Rules 2017. As set forth by the said Rules, Medical Devices Board (MDB) is empowered to grant establishment licenses and establishment/registration of medical devices for marketing in Pakistan. The guidance further describes in detail the corresponding provisions of the aforementioned Rules prescribing the way the reliance approach should be applied.
In accordance with the applicable regulatory requirements, if a medical device subject to review has been already registered by a foreign national regulating authority imposing stricter requirements, the MDB will grant the respective certificate based on such registration.
Furthermore, the rules establish the requirements to be fulfilled in order for the outsourcing of medical devices to be permitted, which also includes registration/approval granted by a foreign national regulatory authority. For the purpose of this provision, the list of trusted jurisdictions includes the USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom.
The reliance approach could also be applied with respect to inspections and exemptions associated thereto. In this regard, the Rules provide that a medical device shall be exempt from inspection under sub-rule (1) where the medical device is approved by regulatory authorities of countries specified in rule 67 irrespective of the fact that the manufacturing unit is not located in these countries.
In accordance with the aforementioned regulatory requirements, the DRAP will apply the reliance approach in cases when:
- Medical device registration is based on the reliance approach;
- Reliance applies to outsource activities.
Reliance Mechanism
The document further describes in detail the reliance mechanism and outlines its key elements which include the following:
- Review of public assessment reports, summary of product characteristics and labeling information;
- Recognition of reported safety and efficacy concerns of already registered medical devices;
- In case information is not available on the official website, the reference regulatory authority is contacted directly via electronic mail for a query or clarification on a particular issue under consideration;
- Regulatory status or any other regulatory information available in the public domain through their website.
Reliance Approach and Importation of Medical Devices
The authority also mentions that the reliance approach to exemptions is quite new. Moreover, starting from 2021, the said approach applies also to the importation of medical devices of various classes.
In particular, in order to be allowed to import Class A medical devices, an interested party should submit the appropriate certificate (ISO 13485, duly notarised), as well as the letter for authorization from the initial medical device manufacturer (should be notarised as well), accompanied with the following documents:
- Notarised free sale certificate from country of origin; or
- Notarised declaration of conformity from a manufacturer abroad; or
- Notarised production or full quality assurance certificate (CE-marking certificate) from the conformity assessment body (CAB).
The document further outlines the scope of documents to be submitted when applying for importation permits for medical devices of higher classes under the applicable risk-based classification (namely Classes B, C, or D). Apart from the aforementioned ISO 134851 certificate and letter of authorization issued by the medical device manufacturer, an interested party will have to submit:
- Notarised free sale certificate from country of origin along with the declaration of conformity, full quality assurance certificate (CE-marking certificate) from CAB. However, for Class D medical devices, a design examination certificate shall be mandatory; or
- Notarised free sale certificate from any of the reference countries i.e., USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom; or
- Notarised free sale certificate from country of origin along with WHO prequalification status.
In summary, the present DRAP guidance describes in detail the way the reliance approach should be applied in the context of the marketing authorization of medical devices intended to be supplied in Pakistan. The document outlines the respective regulatory requirements, highlights the key points to be taken into consideration by medical device manufacturers and their authorized representatives, and also provides additional clarifications regarding the application of the reliance mechanisms with respect to importation approval.
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