Global ISO Requirements

Global ISO Requirements

What is ISO?

ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the ISO. Having around 165 member states, with one representative from each, ISO is a global entity catering to the needs of industry requirements.

Are ISO standards important?

The ISO medical device standards are the Bible for many countries, especially ones which do not have predefined regulations or processes. For regulated countries, in addition to their respective regulations and guidance, ISO standards are also preferred. The most popularly referred ISO standard is the ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. In addition to general standards, ISO also publishes product-specific guidance such as for Implants, Orthopedic, Medical Electric Equipment, and many more.

Global ISO Requirements

In Europe, the European Commission has the Medical Device Regulation MDR 2017/745 and In-vitro Diagnostic Device Regulation IVDR 2017/746. These regulations provide a detailed framework for introducing a medical device in the European market. However, in addition to that, certain ISO standards may also be referred to for ensuring a better-quality product. Some of the many popularly used standards include:

  • ISO 14971:2019 Medical Devices – Application of Risk Management to medical devices
  • ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
  • IEC 60601-2-83 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
  • IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

The European Commission also has Harmonized Standards, developed by European Standards Organization CEN, CENELEC, or ETSI, per the international standards. It provides a list of the applicable harmonized standards for enhanced product safety and quality.

In the USA, the US Food and Drug Administration (FDA) has a Code of Federal Regulations (CFR) and Guidance.

  • CFRs are legally binding. Manufacturers must comply with the requirements of CFR
  • The guidance provides Agency’s thinking on regulatory issues. They are NOT legally binding

In addition to these, the FDA also accepts certain recognized consensus standards from different organizations such as ISO, CLSI, ANSI, IEC, CEN, etc. These standards may be used to justify a Declaration of Conformity for a product. The widely accepted medical device ISO standards are, but are not limited to:

  • ISO 10993 – Biological Evaluation for Medical Devices
  • ISO 14160 – Sterilization of Healthcare Products
  • ISO 11737 – Sterilization of Medical Devices

In Canada, the Standards Council of Canada (SCC) is the ISO member body. Similar to the US FDA, the Therapeutic Products Directorate (TPD) of Health Canada periodically releases a list of acceptable international or national standards for medical devices. Manufacturers can use these recognized standards in conjunction with the Health Canada’s Medical Devices Regulations (SOR-98/282) and the Guidance Documents, to prove product conformity and safe use in the market.

China‘s National Medical Products Administration (NMPA) is developing indigenous standards that more closely align with those of ISO. Biocompatibility testing is one avenue where the scope and requirements for China are more than that of the US/EU. Hence, NMPA has developed various biocompatibility testing standards which are to be used in addition to the ISO standard.

For the rest of the world’s medical device industry,

  • India encourages ISO certification for all its industries. The medical sector must be ISO 13485 compliant while the pharmaceutical sector must be ISO 9001 compliant for Quality Management Systems, in addition to other relevant and applicable ISO standards.
  • Japan’s The Japanese Industrial Standards Committee (JISC) is an ISO member body. The regulatory authority, Pharmaceutical and Medical Device Agency (PMDA) revised its Ordinance No. 169 in 2021 to closely align with the ISO 13485:2016 standard. The transition period is 3 years and must comply by March 25, 2024
  • For the Korean regulatory authority, aligning the requirements of Korean Good Manufacturing Practice (GMP) to that of ISO 13485:2016 is believed to be a step closer to entering the Medical Device Single Audit Program (MDSAP)
  • Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) is known to accept ISO 13485:2016 certification. Information on acceptance of other ISO standards cannot be confirmed. It does not accept market approvals in the US, EU, or other countries as a reference for market authorization in Russia
  • Australia’s Standard Australia is a member of the ISO, IEC, and ICSID. It strongly encourages the use of international standards, except where their use is ineffective or inappropriate and does not develop any national Australian standard for which there is already an international standard in existence. In 2019, TGA published Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 which provides a list of applicable conformity assessment standards.
  • Brazil’s ANVISA accepts Good Manufacturing Practices (GMP) along with the ISO 13485

FAQs

Can QMS be established solely based on ISO standards?

For countries that do not have their own QMS regulations, the ISO standard can be used as a reference. For countries with established local regulations, and that accepts ISO, both ISO standard and local/national regulations must be considered.

Are ISO standards freely available?

No. ISO standards are available for purchase from the ISO official website. However, they do have FREE read-only formats available.

Comparing ISO standards to local regulations, which one takes precedence?

The local or national regulation always takes precedence over the ISO standard.

Can the manufacturer use an older version of an ISO standard for compliance?

No. Manufacturers must make sure they comply with the active or most recent version of the ISO standard. This is not restricted just to ISO standards but applies to National regulations too. Manufacturers must keep their QMS up to date with the latest requirements of the industry. The ideal way to be updated is to refer to the latest version of any Standard or Regulation.

Updates in ANVISA GMP 2022 document 

Updates in ANVISA GMP 2022 document 

Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.  

What is Good Manufacturing Practice (GMP)? 

Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices. 

The GMP document released on 30th March 2022 for Medical and IVD products replaced the GMP document released by ANVISA in 2013. In this article, we will discuss the Significant changes that were made in the latest 2022 Regulations, which supersedes the 2013 version. 

  1. In Art 35 2022 GMP Document, under the document review and archive section, it is explicitly mentioned that – “All digitally stored documents and records shall be backed up.”  
  1. In Art 71 2022 GMP Document, under the Personal health and hygiene section, it is now clearly explained that – “Any individual who, upon medical examination or observation by supervisors, appears to be in a health condition which could affect the product shall be removed from operations until the health condition is deemed adequate.” 
  1. In Art 87 2022 GMP Document under labels and instructions for use, there is an additional point which states – “In the case of importers, the approval documentation referred to in “Labels and instructions for use” article may be recorded in a specific document in lieu of the history record of the product.” 
  1. In Art 112 2022 GMP Document under Distribution Records section, it is now mentioned as:   

Each manufacturer shall maintain distribution records which include or reference: 

I – the name and address of the consignee. 

II – risk: combination of probability of occurrence and severity of damage. 

III – any number control used for traceability. 

Previously in the 2013 GMP document, it was mentioned as: 

Each manufacturer shall maintain distribution records, including or making reference to: 
(i)Names and addresses of the consignee;                                
(ii) Identification and amount of products shipped, with shipment date;  
(iii) Any numerical control used for traceability.  

  1. In Art 114 2022 GMP Document under Identification and traceability of batch production units’ section, there is an additional point added which states- “Each manufacturer shall establish and maintain a program for maintenance, adjustment and, where necessary, cleaning of equipment to ensure that all manufacturing specifications are met.” This is in addition to the identification of the units that are manufactured with every product history record. 
  1. In Art 118 2022 GMP Document, under the Non-conforming components and products section, there is an additional point added which states – “The disposal of the products referred to as “non-conforming” shall be documented, and a record of the justification and manual or electronic signature of the person-in-charge for the disposal of such non-conforming products or components shall be kept.” 
  1. In Art 120-VIII 2022 GMP Document, under the Corrective and preventive actions section, there is additional information added which states – Each manufacturer shall establish and maintain procedures to determine the collection of products and other field actions for those products that are already distributed. The quality process to determine the corrective actions in regard to the identified potential causes shall be based on a valid statistical technique for detecting recurring quality problems, where applicable.” 
  1. In Art 123 2022 GMP Document under the Quality Audit section, there is an additional point added which states – “Those in charge of conducting the quality audit cannot be directly responsible for the matters under audit.” 
  1. CHAPTER 10 in 2022 GMP Document (Final Provisions) is additionally introduced – The chapter includes rules such as:  
  • “The documentation evidencing compliance with the requirements set out in this Resolution shall be made available whenever requested by the health regulatory agencies.” 
  • “Failure to comply with the provisions contained in this Resolution constitutes a health violation, under the terms of Law No. 6.437, of August 20, 1977, without prejudice to applicable civil, administrative and criminal liabilities” 
  • “The following are hereby revoked: 
    I – the Resolution of the Collegiate Board of Directors – RDC No. 16, of March 28, 2013, published in the Federal Official Journal No. 61, of April 1, 2013, Section 1, p. 75;  

II – Normative Instruction – IN No. 8, of December 26, 2013, published in the Federal Official Journal No. 252, of December 30, 2013, Section 1, p. 758.” 

Source: RESOLUTION RDC No. 665, OF MARCH 30, 2022 – RESOLUTION RDC No. 665, OF MARCH 30, 2022 

FAQ 

When will this Resolution come into effect? 

This Resolution comes into force on May 2, 2022. 

What are the terms that got replaced in the new document? 

2013 2022 
Regulation Resolution 
Device history record Product history record 
Device Master Record (DMR) Product Master Record (RMP) 
Compliance Conformity