Japan, Updated guidance on biocompatibility testing of medical devices

Japan, Updated guidance on biocompatibility testing of medical devices

Updated guidance relating to biocompatibility testing of medical devices was released by The Ministry of Health, Labour and Welfare of Japan in February 2020.

With reference to the updated guidance, all biocompatibility testing must be done in accordance with the requirements provided by standard JIS T 0993-1:2020 which actually constitutes an ISO 10993-1 standard in Japanese.

This new document mainly covers the standards when confirming compliance with biocompatibility requirements for the application of approval for manufacturing or marketing medical devices.

It also details the way biocompatibility testing should be done and the particular testing methods to be applied for the results to be reliable and acceptable for its intended purposes.

Partial implementation of the requirements set forth in ISO 14971, which describes the risk management in regards to medical devices was also done in this new update.

Essential definitions such as Raw materials, The final product, Hazard and Risk were specifically highlighted.

The Japanese authorities cautioned that national and international standards could be subjected to review due to the constant development of science and technologies.

Hence, manufacturers are strongly encouraged to stay updated with the latest standards to implement the most appropriate testing method themselves.

India’s central government to regulate all medical devices as drugs

All medical devices in India will be regulated as drugs under Drugs and Cosmetic Act of 1940 with effect from April 2020.

This regulation would focus on ensuring all medical devices in India meets certain standards of efficacy and quality.

The current statistics showed that only 24 out of over 6,000 medical devices are regulated and being notified as drugs.
This change would potentially lead to a higher input cost, especially for local start-ups.

On the flip side, once devices are regulated they would give investors and surgeons the extra confidence to invest and try the products on patients. It will also inspire start-ups to do further research and innovation on medical devices.


New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

Coming into effect on the 1st of July 2020.

Duties and obligations of this regulation are categorized into 6 categories.

  1. Distribution records

Contents required for a distribution record, implantable medical device distribution record and the period of maintenance required.

  1. Records of complaint handling

Complaint handling procedures and requirements for a record of complaint handling and the holding of a complaint record.

  1. Mandatory problem reporting

This involves submitting the investigation report to the Authority which must be done within 30 days.

  1. Field corrective or preventive action

This states that establishments shall notify the Authority before any field corrective or preventive action is being done.

  1. Voluntary recall

This involves the voluntary recall within the time frames as follows,

 Class I (High risk)

No less than 48 hours before the recall is made.

 Class II (Medium risk)

No less than 3 days before the recall is made.

 Class III (Low risk)

No less than 5 days before the recall is made.

  1. Mandatory recall

The Authority may order a recall of any medical device at any time for reasons of patient safety and public health.

Japan, Changes to medical device regulations

An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices (PMD) Act.

The latest version of the PMD Act covers issues such as

  • Application of Artificial Intelligence
  • Unique Device Identifiers
  • Instructions For Use provided in electronic form

There were also changes made to the requirements relating to pre-marketing application submission and post-marketing surveillance.

The goals of this new change are:

  • Simplification of access to the market to make innovative medical devices accessible to patients.
  • Providing a new vision on the functions of healthcare institutions and professionals.
  • Improvement of the regulatory compliance system.

We would see drastic improvements in compliance and supervision systems, thus making communications with manufacturers more efficient through providing legal clarity and certainty of the regulatory requirements.

Indonesia, Directorate of Assessment providing assurance for medical devices and healthy products

Directorate of Assessment Indonesia is providing an assurance for medical devices and household health supplies distributed.

Before products enter the market for distribution all medical devices and household health supplies must attain a marketing authorization number.

This is to ensure that the product quality, safety and efficacy requirements are met. Additionally, providing legal certainty and a healthy business environment. Alongside providing public assurance in the products they use.

This initiative would be done in 4 simple steps.

Step 1: Product Testing

Tests would be done to the product to identify and check for quality and safety requirements and to ensure product consistency and also detect the presence of fake or illegal products.

Step 2: Label Controls

To prevent misleading information from being included. Also ensure that advertising and labeling are objectives, ethical and not include any misleading information or language.

Step 3: Vigilance System Supervision

To prevent the recurrence of the same event and to correct any unexpected event which can potentially still occur even the product has passed its assessment. Such as serious injury, death or deterioration in the health of the patient.

Step 4: Clinical and Technical Information Audit

This activity is under the MoH Directorate Surveillance roles & duties.

Vietnam MOH amend regulations for effective period of the import license and date of CSDT

Vietnam, Ministry of Health (Department of Medical Equipment and Construction) had a Business Dialogue Conference in regard to amended regulations on the management of medical equipment.

Here are some highlights on changes:

  1. Import license validity is till 31st December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid till 31st December 2018) and on import licenses issued in 2019.
  2. For Class B, C, D medical devices that don’t require an import license, importation can continue as normal until 31st December 2021 without a Confirmation Letter from the Ministry of Health, Vietnam.
  3. Vietnam is extending of application of CSDT format until 1st January 2022.

Every registrant should be clear and understand the medical devices and the regulations that are registered.

More details are in the link: www.dmec.moh.gov.vn

Malaysia, Medical Devices advertising

As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from the Ministry of Health Malaysia.

In order to make an advertisement an application for an approval to advertise a registered medical device must be submitted to the Ministry of Health Malaysia in writing accompanied by specific documents.

This regulation will come into full effect starting from 1st July 2020.

Anyone found guilty of breaching this regulation shall be liable to a fine not exceeding RM 200,000 or imprisonment for a term not exceeding 2 years or to both.

To facilitate a smooth process for an approval to advertise a registered medical device.

The following documents and steps are required,

  • Copy of advertisement plan of the medical device.
  • Processing fee of RM 1,000.
  • Letter of appointment from the origin of the medical device which it was registered.

Alongside the following 2 pointers to be included in the advertisement.

  • A certificate that the medical device is registered under the Act.
  • Registration number assigned to the registered medical device by the Authorities.

IMDRF released 3 documents on clinical evaluations, clinical investigations and clinical evidence for medical devices

International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices.

This would replace earlier versions of the documents developed by the Global Harmonization Task Force (GHTF). The documents provides an overview of:

  • General principles of clinical evaluation for medical devices.
  • Principles for designing a clinical investigation and ethical considerations.
  • Key concepts and definitions for clinical evidence.

More details on the IMDRF website:

Malaysia’s guideline for registration of combination products

Malaysia has fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products.

Medical devices with substances incorporated when used on their own could be considered as a medical product, must adhere to this regulation.

Falling under Class D, Rule 13 of the Medical Device Regulation 2012. A medical device-drug combination product registration requires a 3 stage process:

Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)

  • Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
  • Ancillary Drug Dossier (Appendix 2)

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)

Submitting the documentation to the CAB, CAB to issue a certificate and report upon satisfactory assessment.

Stage 3 – Application for Registration to MDA

After obtaining the endorsement letter from the NPRA, certificate, and report from the CAB, an application can be made on Medcast 2.0 for the MDA to evaluate the medical device application.

European Commission released 8 documents for unique device identifiers (UDIs) for medical devices

The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices.

4 of them are relating to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose.  These UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA respectively. The other 4 documents would deal with UDI human readable interpretation (HRI) formats, including HRI qualifiers for UDI-DI, lot number, expiration date, serial number and manufacturing dates.

More details can be found in the EC website: