Home About Qualtech NEWS [ANALYSIS] Post-Market Surveillance Systems in Asia: How Authorities Watch Over Your Products? - July, 2019
[ANALYSIS] Post-Market Surveillance Systems in Asia: How Authorities Watch Over Your Products? - July, 2019

July 18, 2019

Post Market Surveillance (PMS) serves to promote an active teamwork among stake holders – the local government, manufacturers, authorized representatives (AR) and distributor, each taking respective obligations to maintain safe and high-quality products in the local market. PMS carries on a succession of strategies throughout the product life cycle until such time that the product finally exits the market. In a global sense, Post Market Surveillance System covers all aspects of product monitoring, annual reporting, adverse event reporting, and product recalls, with some slight variations across different countries.

Recently, a new definition of PMS has been added in ISO 13485:2016 – “Systematic process to collect and analyse experience gained from medical device that have been placed on the market”, so as to include nonconforming products, feedback, complaint handling, and data analysis within its scope thereby encouraging manufacturers to maintain high quality and safe products. This is roughly analogous to PDCA – a never ending cycle for process improvement.

Local Authorized Representatives are the ones obliged to assist foreign manufacturers in facilitating Post Market Surveillance Activities. AR plays an important role by liaising foreign manufacturers with local Health Authorities. With the impending enforcement of rigorous PMS measures, a broader range of responsibilities would be expected for AR’s. Understanding the expected qualifications and legal competencies of a local Authorized Representative would prove beneficial in accessing the target market. 

As per current regulations, all Health Authorities require foreign manufacturers to appoint a local entity who act as an Authorized Representative of a Locally Registered Foreign Product. The AR takes responsibility of constantly getting in touch with the manufacturer to inform them of product-related regulations issued by the government and local health agencies.

In the succeeding paragraphs, we will quickly go over the current system of Post Market surveillance across three different countries in Asia – China, Singapore, Indonesia, with special emphasis on the responsibilities of Local Authorized Representatives.

China

Background:

In 2008, CFDA has published the “The Measures of Adverse Event Monitoring and Re-evaluation of Medical Device”. The high volume of medical device-related complaints and adverse events has prompted the NMPA to establish a PMS system in order to facilitate an effective approach for managing these issues.

NMPA highly focuses on the obligations of the Legal agent (common term used in China also referred to as “Authorized Representative”). In fact, in 2018, the agency has already issued a draft guidance on the duties and responsibilities of Legal Agents. Although the guidance hasn’t been implemented yet, we can see how Chinese Government proactively responds to keep the current Post Market Surveillance System moving forward.

AR Rights, Obligations, and Qualifications

The obligations of Legal Agent covers the submission of annual product analysis report to NMPA, sending of Chinese regulatory updates to foreign manufacturers, and providing assistance in product registrations , such as license renewal or amendment. Moreover, the Legal Agent shall assist in PMS activities whenever an adverse event or product recall has occurred, and communicate the recall incident or adverse event information to the manufacturer and NMPA.

Currently, the obligation of Legal Agent doesn’t include the importation or distribution related activities. NMPA only authorizes the NMPA-accredited firms to distribute medical devices across the country. With close observation of the future trend, however, NMPA seemed to widen the scope of Legal Agents’ responsibilities in order to improve the current PMS system. Based on the newly published draft guidance of Authority Responsibility in 2018, the Legal Agents shall also be involved in the importation, management of distributors, management of unique distribution identification of each product and so on.

How the Government carries out PMS:

NMPA focuses on post market inspections which covers factory on-site and product inspections conducted yearly. NMPA publishes the overseas inspection guidance of medical device manufacturer to ensure that foreign manufacturers follow Good Manufacturing Practice. In addition, NMPA randomly conducts product inspection throughout the country. For the post market surveillance, NMPA collects the product recall and adverse event report from the Legal Agent. Sometimes, they would ask manufacturers to re-evaluate the safety and effectiveness of the medical device in order to assess whether the medical device needs further modifications.

NMPA branches situated in the provinces oversee the issuance of the distributor licenses and conduct distribution inspection. NMPA branch would report the inspection records to NMPA main institute.

Regulation:

If you are interested in to know the regulation system of Medical Device Distribution in China, here is the quick access for the related regulations:

  

Before we move on to the next Asian country, one thing needs to be clarified. The term “License Holder” refers to a firm having a legal capacity to manage the product license.

License Holder Responsibilities in ASEAN countries may be designated to either the Importer or the Authorized Representative (AR). In Philippines, Indonesia and Thailand, the importer assumes responsibility of the License Holder.

Singapore, Malaysia and Vietnam, on the other hand, requires an AR to hold the license. AR can authorize other qualified device distributor to do the import and distribution locally. For this issue, we will focus on Singapore and Indonesia’s PMS system while incorporating some information on the responsibilities of Authorized Representatives in the respective countries.

 

Singapore

Background:

With the country’s high dependence on international trade, Singapore HSA has developed a comprehensive system for post-market surveillance. SG Medical Device Establishments comprise different roles in the market:

❃ Manufacturer: Any company who manufacturers medical device in Singapore;

❃ Importer: Any company who imports medical devices into Singapore;

❃ Registrant: In relation to a registered health product, means the person who applies for and carries out registration activities in accordance with the Health Products Act;

❃ Wholesaler: Any company who supplies medical devices in bulk quantities (which includes export) in Singapore.

Singapore HSA has amended the current guidance documents in order to help the agency effectively regulate the legal scope of license and company qualification and to further assist companies to get the corresponding license they are applying for.

AR Rights, Obligations, and Qualifications

Authorized Representative assumes responsibility as a Registrant. Registrants are scope of obligations cover not only the registration part but also product recalls, field safety corrective actions (FSCA) and mandatory adverse event reporting. As per HSA regulations, only the importer and wholesaler could carry out distribution activities. If AR’s wish to expand their scope of service as a distributor, they should obtain the certificate of Good Distributor Practice Medical Device (GDPMD). Only Class A medical devices are exempted from this requirement.

How the Government carries out PMS:

Importers and wholesalers are required to compile all distribution records which will later be inspected by Conformity Assessment Body (CAB) according to GDMPDS. The registrant shall also notify HSA all reportable adverse events and recalls , and provide all the necessary documentations requested by the HSA. Manufacturers, in turn, shall do appropriate actions to correct the errors and reduce risks associated with the use of the device. Finally, the manufacturer shall submit the Field Safety Corrective Action (FSCA) and Field Safety Notice to HSA via the registrant. Safety communication of FSCAs  reported to the HSA are publicly accessible as filed safety notices (FSN) on the HSA website.

Regulation

If you are interested in to know the regulation system of Medical Device Distribution in Singapore, here is the quick access for the related regulations on their website:

❃ GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

❃ GN-10: Guidance on Medical Device Field Safety Corrective Action

 

Indonesia

Background

Indonesian Government has established system for distribution processes early in 2004. The system has been developed based from the Regulation of the Minister of Health Number 1184/MenKes/Per/X/2004. In order to improve surveillance of products in the market, Indonesian Ministry of Health (MoH) has published the 1191/MENKES/PER/VIII/2010 Regarding Distribution of Medical Devices, which covers the requirements of quality, safety and efficacy of the distributed medical device should comply with.

AR Rights, Obligations, and Qualifications

In Indonesia, the term “distributor” is most often used compared to “AR”. The medical device distributors, also termed as “PAK” (Penyalur Alat Kesehatan) is a company that is duly licensed to procure, store, import, and export medical devices. In addition, PAK also holds the “market license” (a commonly used term in Indonesia also referring to “product license”). The warehouse should comply with norms and regulations in order to ensure safety and preservation of the devices’ critical attributes (e.g., sterility, packaging integrity, etc.) during storage. Moreover, following the Good Distribution Practices of Medical Device (GDPMD) is necessary to obtain the PAK license issued by the Director General.

PAK’s is required to report pertinent distribution activities (e.g., vigilance, product recall, eradication, procurement) once every year. They are also in charge of product license renewal and amendment. During product recalls or vigilance reporting, PAK also serve as a contact person of the MoH. Hiring a staff with a good regulatory background in PAK would be highly necessary for these types of businesses.

Government Action on PMS

The MoH carries out the following regulatory measures to ensure that HED’s act as duly in accordance with National Regulations

  • Audits PAK on GDPMD,
  • Inspection on the means and infrastructure,
  • Sampling and testing, and
  • Control on labelling and advertisement.

When the vigilance or product recalls are being reported, the government also follows up the report from the HED. The MoH Directive General is also in charge of issuing the PAK license to the HED. The license has a 5-year validity period, which shall be renewed periodically.

Regulation

If you are interested in to know the regulation system of Medical Device Distribution in Indonesia, here is the quick access for the related regulation: 1191/MENKES/PER/VIII/2010 Regarding Distribution of Medical Device.

 

Conclusion

PMS takes most of the entire length of the product’s lifespan. During the initial registration, the Health Authorities study all key information relating to the device’s safety and performance. This information, however, does not truly reflect the overall performance of the device once it gets into the market. Measures in reducing risks related to device’s use is a critical topic and remains as an ongoing goal for Health Authorities across the globe. Clearly, putting emphasis on product monitoring and post-market surveillance is one efficient way to achieve this goal.

Most countries in Asia has not fully responded yet to the current situation on skyrocketing recalls and adverse event occurrences due to lacking resources in setting up regulatory systems to effectively control the safety and quality of devices entering the local market. Hopefully, with the introduction of Unique Device Identification (UDI) systems, Health Authorities could start putting up some measures on how to utilize such information in the domestic surveillance systems.

Designating Authorized Representatives locally is essential for all manufacturers. Not all manufacturers are willing to put up businesses in local countries. However, choosing the right AR’s is an important question. With 20-year experience and excellent background on local representation, we believe that we could provide our clients with a better understanding on who Authorized Representatives are. If you have any concerns or questions, feel free to contact us.

 

References:

1.  Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device

2. Provisions for Supervision of Medical Device Distribution

3.  Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices

4.  Product Recall Regulation

5.  The Measure of Qualification of Medical Device Usage

6.  Regulations on the Administration of Overseas Inspection of Medicine and Medical Devices

7.  GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

8.  GN-10: Guidance on Medical Device Field Safety Corrective Action

9.  1191/MENKES/PER/VIII/2010

 

Tags:

Post Market, Asia, Authorized Representative

 

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Home About Qualtech NEWS [ANALYSIS] Post-Market Surveillance Systems in Asia: How Authorities Watch Over Your Products? - July, 2019