Indonesia: Halal Certification

Halal

The Government of Indonesia issued Regulation No. 33 dated October 17, 2014, concerning the Halal Products Guarantee. Article 67 states that the obligation for halal certificates for products circulating and traded in the territory of Indonesia will come into effect 5 (five) years from the date the regulation was issued.

Indonesia is a country with the largest Muslim population in the world. Therefore, the Government are trying to guarantee that all products circulating in Indonesia are halal.

To support this, the Government of Indonesia issued Regulation No. 33 dated October 17, 2014, concerning the Halal Products Guarantee. Article 67 states that the obligation for halal certificates for products circulating and traded in the territory of Indonesia will come into effect 5 (five) years after the regulation was issued. Thus, the obligation to seek halal certification will come into effect on October 17, 2019.

On the 29 April 2019, the President of the Republic of Indonesia, Ir. Joko Widodo, set President Regulation, PP No. 31 of 2019 to initiate implementation of Regulation No. 33 of 2014 concerning the guarantee of halal products.

Products circulating in Indonesia that are required to have halal certification include food and beverage products, pharmaceutical drugs, cosmetics, chemical products, biological products, genetic engineering products, and goods that are used, or utilized. The items that can be utilized is Medical Devices. As for Goods that are required to be halal certified only those containing animal elements.

The application of halal certification for these products is carried out in stages with grace period for each. Medical devices are divided into 4 risk classes with the grace period as follows:

Risk Class A – 7 years (up to October 17, 2026)
Risk Class B – 10 years (up to October 17, 2029)
Risk Class C – 15 years (up to October 17, 2034)
Risk Class D – (set in President Regulation)

2019-08-02T17:11:46+08:00 July 31st, 2019|Insight, Medical Regulation Updates, News & Events|

Singapore: Health Science Authority sets up Committee to Review the Management of Sensitive Data

The Health Sciences Authority (HSA) Singapore has set up a committee to review its policies and processes for effectively managing sensitive data and to recommend appropriate measures to avoid future occurrence of breaches. The Health Ministry and its agencies will also be reviewing the life cycle management of the data that is being handled by their existing information technology vendors.

In March 2019, it was revealed by the Health Science Authority that the personal information of more than 800,000 blood donors which was put online improperly by a vendor for over two months was accessed illegally and was possibly stolen. It was confirmed by Secur Solutions Group (SSG), an independent vendor of the HSA, said the server had been accessed from several other IP addresses apart from the foreign cyber-security expert who had spotted the vulnerability in the server.

The database containing the personal information of blood donors was uploaded to the server around October last year. This information included the names, NRIC numbers, gender and number of donations of people who have donated or registered to donate blood in Singapore since 1986.

In a statement, the HSA said it was aware of the situation, and added that it takes a serious view of the matter, which the police are investigating. The agency said that SSG was in breach of its contractual obligations and it would decide the steps it should take regarding the vendor once investigations are concluded.

The HSA has set up a committee to review its policies and processes for effectively managing sensitive data and to recommend appropriate measures to avoid a future occurrence of similar breaches. The Health Ministry and its agencies will also be reviewing the life cycle management of the data that is being handled by their existing information technology vendors. One of the suggestions that came up is to streamline the procurement process of IT services across departments, statutory boards and public hospitals to reduce personal data access by multiple vendors.

2019-08-02T17:15:08+08:00 July 31st, 2019|Insight, Medical Regulation Updates, News & Events|

FDA’s Center For Device Regulation, Radiation Health and Research (CDRRHR) to host the 8th ASEAN Medical Device Committee Meeting

The CDRRHR will be hosting the 8th ASEAN Medical Device Committee Meeting and its related activities in the Philippines and will be held at the Shangri-la Hotel, Makati City from the 4-8 August 2019.

The FDA’s Center for Device Regulation, Radiation Health and Research (CDRRHR) will be hosting the 8th ASEAN Medical Device Committee Meeting and related activities in the Philippines and will be held at the Shangri-la Hotel, Makati City from the 4-8 August 2019. The event includes an Industry Training Session and Public-Private Forum, which will serve as capability building activities for the AMDC, and will run parallel to the closed door AMDC Technical Committee and Main Meetings for the regulators. The regulators program of activities is outlined below.

On a separate note, any transactions for medical device applications at the FDA will be suspended during the duration of this event. All transactions will resume on August 12, 2019.

2019-08-02T17:37:38+08:00 July 31st, 2019|Insight, Medical Regulation Updates, News & Events|

Malaysia: Notification of Export-Only Medical Devices

The Medical Device Authority (MDA) in Malaysia released the first edition guidance document, MDA/GD/0051, related to the Notification of Export Only Medical Devices. The ‘Acknowledgement on Notification’ letter permits multiple export consignments within a specific validity period.

On 16th July 2019, the Medical Device Authority (MDA) in Malaysia released the first edition guidance document, MDA/GD/0051, relating to the Notification of Export Only Medical Devices.

Back in 2018, the MDA released Circular Letter, No. 4 Year 2018, titled “Exemption from Registration Requirements for Export Only Medical Devices”. This Circular Letter exempts medical devices that are for export only from registration requirements; such devices only require notification to the Authority. Once the MDA has issued an “Acknowledgement of Notification” letter, then the medical devices are permitted to be exported. This newly released guidance document will explain to the license establishment, contract manufacturer and authorized exporter how to apply for the notification from the MDA.

The applicant is required to fill out a form, Annex B “Notification of Export Only Medical Device Form”. Once the form has been filled out, the applicant mustl submit the application form by email to exportonly@mda.gov.my. The applicant must submit the notification before exportation of the first shipment so that an “Acknowledgement on Notification” letter can be issued before exportation of the medical device. Any additional information, particulars or documents required by the authority must be provided by the applicant within 14 days of the date of request made to the authority. The inability of the applicant to produce documents when requested by the Authority may result in the cancellation of the application and the applicant must submit a new application. One notification application must be submitted for each medical device nomenclature.

Each notification shall be submitted together with a RM500 fee and the payment must be made via bank draft.
Upon receipt of a completed application and the clearance of payment, the Authority will issue an “Acknowledgement of Notification” letter to the applicant within 14 working days from the clearance of payment, by letter and email. This “Acknowledgement of Notification’ letter permits multiple export consignments within the validity period, which is set at five (5) years.

This guidance document can be accessed here and the Annex B form can be downloaded from here.

2019-08-05T09:03:31+08:00 July 31st, 2019|Insight, Medical Regulation Updates, News & Events|

Thailand: Updated Medical Device Act (2019) and Medical Advertisement Regulations

medical device act

The ThaiFDA has issued the amended Medical Device Act (Issue 2) B.E. 2562 (2019), which will come into effect in October 2019. This supersedes the Medical Device Act BE 2008.

The amendments include changes to the rules and process of evaluation of medical device and the inclusion of relevant provisions to improve efficiency in the medical device registration process. These changes were required because certain provisions in the previous version of the Act were inappropriate under current circumstances where there are rapid developments in technology and medical innovations. These developments have resulted in changes and expansion in the trade and industries related to medical devices. The key changes include:

  • Revision to the definition of registrant and accessory
  • Changes to the powers of the Minister to issue Notifications
  • Changes to the composition of the Board
  • Amendments to licence applications and licensing
  • Provisions implemented on the cessation and transfer of operations
  • Changes to the duties of the licensee, specifications provider and vendor
  • Amendments to labeling and medical device documentation,
  • Improvements in the control of medical devices such that no person shall manufacture, import or sell medical devices that are manufactured or imported without conforming to a license or declared specification
  • Changes regarding the advertisement of medical devices
  • Amendments to the powers and duties of the competent official
  • Provisions made regarding the suspension and revocation of the establishment registration certificate, license, and specifications declaration receipt, and appeals
  • Inclusion of provisions pertaining to the registration of establishments, medical device assessments, civil liabilities, including revisions of penalties and fees for greater suitability

Following the issuance of a Ministerial Regulation to prescribe fees, different fee rates may be prescribed based on the category, group, type of medical device, size and operation of the operator and type of amendment.

Changes to regulations regarding the advertisement of medical devices

The license to advertise a medical device in Thailand requires approval from the Thai FDA. The advertisement of a medical device must first be licensed by the licensor. A license shall be valid for a period of not more than three years as from the date of issue. A license application, licensing and license validity period shall be in accordance with the rules, procedures, and conditions prescribed by the licensor provided that the licensor may also prescribe specific conditions of advertisement and restrictions on advertising media.

A medical device advertisement must:

  • Not be a false or exaggerated representation of the benefits, quality, quantity, standard, constituent or origin of the medical device
  • Not represent any person’s endorsement or commendation of the medical device’s benefits
  • Not offer a prize conditional upon the taking of chance by any means
  • Not represent benefits in regard to the prevention, treatment, relief or cure of a disease or symptom of a disease for which advertisement is prohibited under a Notification published by the Minister
  • Not contain a misleading statement on an essential substance in relation to the medical device. And in the case where the licensor finds that an advertisement is in violation, the licensor shall have the power to issue any of the following orders:
    o To make changes to the content or means of advertisement
    o To prohibit the use of certain statements or means appearing in the advertisement
    o To suspend the advertisement. The licensor may also order the advertisement of correct information.

2019-07-09T22:20:32+08:00 July 1st, 2019|Insight, Medical Regulation Updates, News & Events|

E-Learning with Andaman Medical!

Andaman Medical is going to launch its first e-Learning platform in July 2019! Engaging us in this e-Learning program will let you gain insights on the regulatory framework and general pathway for medical device registration in the Southeast Asia region.

Andaman Medical is going to launch its first e-Learning platform in July 2019!

Andaman Medical is a consulting company that specializes in registering medical devices in Southeast Asian countries, as well as being your independent license holder. Those countries include Indonesia, Vietnam, Philippines, Thailand, Singapore, and Malaysia.

Engaging us in this e-Learning program will let you gain insights on the regulatory framework and general pathway for medical device registration in these countries.

The course will begin with an overview of the regulatory pathway for the country with an emphasis on the current system and the implementation of new regulations by the authorities. The e-Learning platform will also work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to the regulations and how these are submitted for approval. The execution of all work within the main workflow will be covered with details of tasks, timelines, and costs.

2019-07-09T22:31:03+08:00 July 1st, 2019|Event, Insight, News & Events|

Vietnam: Common Mistakes Made When Importing Medical Devices

importation

A delay in the importation process can contribute to profit loss and uncertainty for companies looking to import medical devices into Vietnam. We have identified several ways to help prevent delays in the process.

With the implementation of the guidelines for medical device importation in 2019 (Decree 36) in Vietnam, there are several points worthy of consideration that can help to prevent delays in the implementation process:

1. Make sure all documentation is consistent
In order to import a medical device, the importer must apply for an import license if that medical device belongs to the list of 49 medical devices that require an import license as per Circular 30/2015/TT-BYT. The format of the documentation must follow the guidelines from the Vietnam Ministry of Health in terms of phrasing and wording. Documents that require legalization must be legalized correctly. All the product codes should be stated on the CFS of the product.

2. Label
The label should be consistent with the application documentation for the import license. Information such as “Model”, “Manufacturer”, “Made in” on the label must be identical to the declared information otherwise the shipment could be delayed, and the importer may be required to pay a Customs fine.

3. Incorrect information:
Different information (Model, Manufacturer, Name,…) between the label and the import license and/or product license could cause delays in customs clearance. The Customs Department will require the importer to re-apply for a new license.

4. Differentiation between non-commercial goods and tax-duty goods:
Medical devices for use in exhibitions, repair and/or maintenance must apply for permission from the Ministry of Industry and Trading to be gain duty-free status. The serial number on the model intended for a special purpose should match the devices in the shipment. Medical devices that require an import license as per Circular 30 must obtain the import license first. Other samples or medical devices for trials should be classified as per the regulations, by attaining a classification result in Vietnam first. If the device is a Class A medical device, the importer should apply for the notification of applicable standards (Class A) before importation.

5. Systems of a medical device:
Parts of a system of a medical device should be listed as a single list in order to have the same tax duty.

6. Classification of medical devices before importation:
Devices that do not require an import license as per Circular 30 can be imported without an import license as long as they have attained a classification result by from the necessary Vietnamese establishment.

2019-07-04T05:33:19+08:00 July 1st, 2019|Insight, Medical Regulation Updates, News & Events|

Malaysia: Post-Marketing Responsibilities for Manufacturers and Authorized Representatives

The first circular letter of 2019 from the Medical Device Authority in Malaysia has addressed the post-marketing responsibilities for manufacturers and authorized representatives who have ceased business after placing medical devices in the market.

On 15th April 2019, the Medical Device Authority (MDA) of Malaysia released the first circular letter of 2019, which addressed the post-marketing responsibilities for manufacturers and Authorized Representatives who cease business after placing medical devices in the Malaysian market.

The enforcement of this regulation is important because of the need for accountability for post-marketing issues such as complaints, incidents, and recall of medical devices.

According to the circular letter, this regulation relates to three potential situations:

a) The authorized representative (AR) closed its business with no replacement after placing a medical device in the market.
Policy Decision: the AR shall be responsible for post-marketing issues for at least the projected useful life of the medical device as determined by the manufacturer.

b) The AR closed its business after placing the medical device in the market and is replaced by another AR.
Policy Decision: The newly appointed AR shall be responsible for post-marketing issues associated with the medical device.

c) The manufacturer closed its business with no replacement after placing a medical device in the market.
Policy Decision: The manufacturer shall be responsible for post-marketing issues for at least the projected useful life of the medical device as determined by the manufacturer.

The implementation and enforcement control of post-marketing responsibility for manufacturers and authorized representatives shall come into effect on the 15th April 2019. The circular letter can be viewed here.

2019-07-09T22:19:11+08:00 July 1st, 2019|Insight, Medical Regulation Updates, News & Events|

Vietnam: In Vitro Diagnostic Reagent Registration And Importation

Registration numbers of medical devices that are In Vitro Diagnostic Reagents and granted the Certificate of Registration in accordance with the 2005 Law on Pharmacy and its instructional documents, will be effective until the expiration date on their Certificate of Registration.

The registration numbers of In Vitro Diagnostic Reagents with an expiry date after January 01, 2019 and before December 31, 2019 will be effective until the end of December 31, 2019.

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2019-06-04T20:34:37+08:00 June 4th, 2019|Insight, Medical Regulation Updates, News & Events|

Singapore: Update For Change Notification Guidance For Registered Medical Devices

On March 28th, 2019, the Health Science Authority (HSA) provided updates corresponding to the GN 21: Change Notification of Registered Medical Devices.

The updates come following industry feedback to the range of terminology used across the various guidance documents and the lack of clarity in documentary requirements for different change notification cases.

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2019-06-04T20:28:33+08:00 June 4th, 2019|Insight, Medical Regulation Updates, News & Events|