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In our previous blog we have discussed about Ophthalmoscope. Please check out for the link below.

In today's blog we will discuss about Medical Device Single Audit Program (MDSAP).

MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.

Let's get into the topic.

WHAT IS MEDICAL DEVICE SINGLE

AUDIT PROGRAM?

The Medical Device Single Audit Program (MDSAP) is a program that allows performing a single audit of a medical device manufacturer’s quality management system which satisfies the requirements of multiple regulatory bodies. The MDSAP Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities (Participating countries) to audit under MDSAP requirements.

Audits performed under the MDSAP program will be based on the requirements for risk management. Effective implementation of the risk based approach usually starts with the design and development process, product realization, including the selection of suppliers. It also considers feedback from post-market monitoring and continues until the time the product is decommissioned.

The verification of QMS documentation should be performed as part of the pre-audit preparation and documentation review, to minimize the on-site audit time and also to increase auditor’s familiarity with the medical device organization’s QMS.

WHAT ARE THE COUNTRIES

PARTICIPATING IN MDSAP?

The following are the countries participating in MDSAP.

1. Health Canada

2. The Australian Therapeutic Goods Administration (TGA)

3. The Brazilian Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA)

4. The Japanese Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

5. The United States Food and Drug Administration (FDA).

HOW MDSAP AUDITS CONDUCTED?

The MDSAP Audits covers the Medical device – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) and corresponding regulatory requirements of the Australian Therapeutic Goods (Medical Devices) Regulations (SR 236, 2002), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Canadian Medical Device Regulations (CMDR, Part 1), the Japanese QMS ordinance (MHLW MO 169), the Quality System Regulation (21CFR 820), and other country specific requirements.

WHAT IS MDSAP AUDIT SEQUENCE?

The MDSAP Audit sequence has four primary processes which include Management process, Measurement, Analysis and Improvement process, Design and Development process, Production and Service control process along with the links for supporting process of purchasing.

The MDSAP has two additional supporting processes, Device Marketing Authorization and Facility Registration, Medical Device Adverse Events and Advisory Notices Reporting.

WHAT IS MDSAP AUDIT CYCLE?

The Medical Device Single Audit Program follows a three year audit cycle. The first step starts with the Initial Audit, which is also referred to as the Initial Certification Audit. It is a complete audit of a medical device organization’s quality management system (QMS). The Initial Audit consist of a Stage 1 Audit (17021-1:2015 – Cl 9.3.1.2) and a Stage 2 Audit (17021-1:2015 – Cl 9.3.1.3).

The initial Audit is followed by a partial Surveillance Audit (17021-1:2015 – Cl 9.6.2.2) in each of the following two years and a complete Re-audit called as a Recertification Audit (17021-1:2015 – Cl 9.6.3.2) in the third year. A recertification audit may also include a Stage 1 audit if there have been significant changes to the QMS that have not been otherwise adequately assessed.

Special Audits (17021-1:2015 – Cl 9.6.4.2) are audits Conducted by Regulatory Authorities.

Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle.

WHAT ARE THE ANNEXES?

ANNEX 1:

The annex 1 contains country specific information as to the expectations for the audit of product or process related technologies (other than sterilization – See Annex 2) and the audit of technical documentation as part of the execution of the Audit Tasks.

ANNEX 2:

The annex 2 contains information as to the expectation for the audit of requirements for sterile medical devices.

ANNEX 3:

The annex 3 contains a table showing a summary of time frames for reporting advisory notices and individual adverse event reports in the participating MDSAP jurisdictions.

ANNEX 4:

The annex 4 contains country specific guidance on expectations for various types of written agreements for regulatory purposes.

AUDIT OF EXTERNAL SUPPLIERS

Auditing Organization has the rights to audit external suppliers of a medical device organization, including corporate suppliers. The medical device organization must have proper controls over outsourced processes that provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The term critical suppliers covers the entities with following functions.

1. The suppliers who supply the organization with finished devices. Example: Device, or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labelled, or sterilized.

2. The suppliers of products, including services, that impact design outputs that are essential for the proper functioning of the device.

3. The suppliers of products and services that require process validation

HOW NON CONFORMITIES ARE

HANDLED?

Particular attention should be given to the potential interrelationship of the nonconformities observed. Nonconformities identified from the audit should be graded on a scale from 1 - least critical to 5 - most critical, and will be managed according to criteria defined in the document GHTF/SG3/N19:2012, Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange.

Now I hope you have acquired some knowledge about Medical Device Single Audit Program. We will discuss in detail about a topic related to Biomedical Engineering in our future blogs.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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