SQA Regulatory Surveillance Summary | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates
SQA Regulatory Surveillance Summary, #1 2021
Agência Nacional de Vigilância Sanitária (ANVISA)
The driving principles of the ANVISA Annual Management Plan (PGA) are to increase efficiency, improve the quality of service, focus on results, and guarantee better transparency. The PGA was produced after a thorough process, including the participation of various departments of ANVISA. The principal focus of the Plan is to introduce a management model that is more agile, dynamic, adaptable, and transparent, with the aim of better aligning the execution of strategy at all levels of the organization.
China Guidances and Regulations
The National Medical Products Administration (NMPA) has partially revised the Medical Device Classification Catalog, as described in Announcement No. 147 of 2020 (link in Chinese). Noteworthy changes consist of the down-classification of 15 device types (including optical endoscopes and medical microscopes) and revisions to the entries for 13 product categories (including additional classification adjustments). The changes are summarized in annexes attached to the announcement.
As of 31 December 2020, registration and filing applications must be submitted according to the adjusted classification catalog. Applications that have been accepted but not yet approved (including both initial registration and renewal applications) will be reviewed and approved according to the previous version of the catalog, and the registration certificate will indicate the adjusted classification or category. For registered devices, the registration will remain valid until expiration, but classification information may need to be adjusted upon the next renewal. If there are any changes during the validity period, the applicant must apply for these changes based on the original version of the catalog, and the registration certificate will include an indication of the adjusted classification.
The Center for Medical Device Evaluation (CMDE) issued its Announcement No. 26 of 2020 (link in Chinese), relating to the submission of Unique Device Identifier (UDI) information. China’s UDI pilot program wrapped up at the close of 2020; it was previously slated to end in October, but the NMPA extended this trial period due to the impact of the COVID-19 pandemic. Compliance with UDI requirements will now be enforced for the first batch of devices in the agency’s phased implementation plan. The announcement deals with UDI-DI submission via the eRPS system for medical device registration applications. An attachment to the announcement provides a list of the medical device categories currently subject to UDI requirements, and applicants with devices on this list must complete and upload UDI-DI information according to the template provided when submitting a registration, renewal, or modification application in the eRPS system.
Sunstar Americas Inc. is expanding its recall for its prescription anti-gingivitis oral rinse, GUM Paroex, to all lots on the Canadian market. The additional lots are being recalled, as a precaution, because they may be contaminated with the bacteria Burkholderia lata.
Health Canada is advising:
- Do not use rinses labeled with one of the lot numbers listed in the recall alert.
- Consult your healthcare provider immediately if you’ve taken this product and are experiencing respiratory or other medical issues.
- Report any health product-related adverse reactions or complaints to Health Canada.
Health Canada is warning Canadians that the company Maskopia (formerly known as Medkem Canada Inc.) in Brampton, Ontario, has been selling personal protective equipment (PPE), including gowns, masks, and gloves, via social media and websites such as Kijiji without the required Medical Device Establishment License (MDEL) from Health Canada. Canadians are advised to immediately stop using these products and to dispose of them, as they may not provide the level of protection advertised due to unknown quality and safety. Maskopia does not hold a MDEL, which is required to import or sell medical devices (including PPE) in Canada. Health Canada also refused an application from the company for authorization to sell its gowns under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 because they did not meet all of the requirements. Despite Health Canada’s direction to stop sale, the company has continued to sell its isolation gowns to various healthcare practitioners and consumers. Maskopia has also falsely advertised and sold non-medical masks as medical masks.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidances
The ICH Reflection Paper on Patient-Focused Drug Development (PFDD) identifies key areas where incorporation of the patient’s perspective could improve the quality, relevance, safety, and efficiency of drug development and inform regulatory decision making. It also presents opportunities for the development of new ICH guidelines to provide a globally harmonized approach to the inclusion of the patient’s perspective in a way that is methodologically sound and sustainable for both regulated industries and regulatory authorities. As part of ICH public consultation on this Reflection Paper, stakeholders are invited to provide their comments to their respective Regulatory Authorities or directly to the ICH Secretariat by 07 March 2021 at firstname.lastname@example.org.
Medicines and Healthcare Products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. The Guidance – Regulating Medical Devices in the United Kingdom (UK) provides information on the UK system, including:
- Getting your device certified
- Conformity marking your device
- Registering your device with the MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland, and the European Union (EU). Great Britain includes England, Wales, and Scotland. For Northern Ireland, different rules apply from those in Great Britain. The guidance includes information on the regulatory system for medical devices in Northern Ireland.
Since 01 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales, and Scotland). These are:
- CE marking will continue to be recognized in Great Britain until 30 June 2023
- Certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- The EU no longer recognizes UK Notified Bodies
- UK Notified Bodies will not able to issue CE certificates (other than for the purpose of the “CE UKNI” marking, which is valid in Northern Ireland) and have become UK Approved Bodies
- A new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market
Additional information is provided with respect to the requirements for MHRA registration of medical devices.
CSL Behring UK Ltd is recalling two batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process. There is a risk of potential microbial contamination due to the failure of the HEPA filters at the manufacturing site, and the batches are being recalled as a precautionary measure. This product is only supplied to pharmacies and/or hospital pharmacies and not to wholesale, via Third-Party Logistics (3PL) partner Alloga UK Ltd.
Merck Sharp & Dohme Limited is recalling six batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion, EL (20)A/60, due to the presence of Ralstonia pickettii (R. pickettii) in recent batches that were manufactured. The batches are recalled as a precautionary measure whilst investigations into the microbiological quality of the distributed products are underway. The potential for contamination of the batches is low. If R. pickettii is found to be present, the risk that these products would contain viable R. pickettii in a level that could cause serious adverse health consequences is considered to be low. R. pickettii is a gram-negative, non-motile, non-spore-forming, rod-shaped bacteria found in soils, rivers, and lakes. It is also present in biofilms bacteria (collective of one or more types of microorganisms that can grow on surfaces) in industrial plastic water systems.
Therapeutic Goods Administration (TGA)
Under the current medical devices regulatory framework, custom-made medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically. Higher risk custom-made medical devices, including orthopedic implants, are now available, and their continued supply under the custom-made medical devices exemption requires independent oversight. The Therapeutic Goods Administration (TGA) has conducted extensive consultation and liaison with industry members and other global regulators, designing a new framework for medical devices that are designed and manufactured for individual patients. Collectively, these changes are known as the “personalized medical devices framework.” The framework has been introduced by the Australian Government to ensure that an appropriate level of regulation is applied to personalized medical devices in order to manage the risks associated with their use.
Under the new framework, regulatory requirements that apply from 25 February 2021 will:
- Introduce new definitions for personalized medical devices, thereby reducing the scope of the existing definition of a custom-made medical device
- Change the conditions of exemption for custom-made medical devices to:
- Require annual reporting of custom-made devices supplied in the previous financial year
- Allow the TGA to inspect production facilities
- Require documentation about the device to be retained for five years (for non-implantable devices) or 15 years (for implantable devices)
- Require manufacturers to provide information about each custom-made medical device to the intended recipient
- Introduce the new concept of a Medical Device Production System (MDPS) and a framework for regulating these systems to allow healthcare providers to produce personalized devices for treating their patients, without the need for manufacturing certification
- Update the classification rule for medical devices that record diagnostic images to include a broader range of technology now used for the purpose of recording patient anatomy for diagnosis and investigation, including anatomical models